Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Mohan Z Mani

"Thank you very much for having published my article in record time.I would like to compliment you and your entire staff for your promptness, courtesy, and willingness to be customer friendly, which is quite unusual.I was given your reference by a colleague in pathology,and was able to directly phone your editorial office for clarifications.I would particularly like to thank the publication managers and the Assistant Editor who were following up my article. I would also like to thank you for adjusting the money I paid initially into payment for my modified article,and refunding the balance.
I wish all success to your journal and look forward to sending you any suitable similar article in future"



Dr Mohan Z Mani,
Professor & Head,
Department of Dermatolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Research Protocol
Year : 2024 | Month : August | Volume : 18 | Issue : 8 | Page : QK01 - QK04 Full Version

Effect of Callisthenic Exercises vs Yoga on Health Related Quality of Life, Lipid Profile, Anthropometric Measurements and ultrasonography Findings in Polycystic Ovarian Syndrome: A Research Protocol


Published: August 1, 2024 | DOI: https://doi.org/10.7860/JCDR/2024/70336.19725
Ashwini Bulbuli, Vijay Kage, Manjunath Hukkeri, MB Bellad

1. Associate Professor, Department of OBG Physiotherapy, KLE Institute of Physiotherapy, Belagavi, Karnataka, India. 2. Professor, Department of Orthopaedic Physiotherapy, KLE Institute of Physiotherapy, Belagavi, Karnataka, India. 3. Assistant Professor, Department of Obstetrics and Gynaecology, JN Medical College, Belagavi, Karnataka, India. 4. Professor, Department of Obstetrics and Gynaecology, JN Medical College, Belagavi, Karnataka, India.

Correspondence Address :
Ashwini S Bulbuli,
Associate Professor, Department of OBG Physiotherapy, KLE Institute of Physiotherapy, Belagavi-590010, Karnataka, India.
E-mail: ashwinichougala05@gmail.com

Abstract

Introduction: Polycystic Ovarian Syndrome (PCOS) is an endocrine disorder, and individuals with this condition are at a risk of developing complications like metabolic syndromes throughout their lifetime. Not much is known about studies reporting the combined effects of calisthenic exercise with either aerobic exercise or progressive resistive exercises that have shown positive outcomes in PCOS.

Need for the study: Extensive literature search has revealed gaps in reporting the individualised effects of calisthenic exercise in PCOS and its comparative effects with yoga. The present research article presents a study protocol comparing calisthenic exercises and yoga protocols prescribed for women with PCOS.

Aim of the study: To evaluate and compare the effects of calisthenic exercises and yoga in women with PCOS.

Materials and Methods: This research protocol is planned to conduct a randomised clinical trial in Belagavi, Karnataka, India, and will employ a randomised, open-label, parallel-armed, double-blinded clinical experimental design. The duration of the study will be near bout four years, from June 2022 to August 2026. A total of 102 females with PCOS, aged between 18 and 35, will be randomly allocated to either a yoga group (N=51) or a calisthenic exercise group (N=51). For a period of 1½ months (i.e., six weeks), group therapy sessions will be held five times a week. Ultrasonography scans, which will assess ovarian cyst count and size, ovarian volume, and total lipid profile, will be conducted twice (pre- and post-intervention). The PCOS Questionnaire (PCOSQ-26) will be utilised to assess health-related quality of life, as well as anthropometric measurements such as waist-hip ratio and Body Mass Index (BMI). These measurements will be assessed prior to the intervention, six weeks following the intervention, and at the 12-week follow-up. Inferential as well as statistical methods will be used to analyse the gathered data. A test for normal distribution will be conducted, depending on whether parametric tests (Z test and/or ANOVA) or non-parametric tests (Mann-Whitney U test or Wilcoxon signed-rank test) will be performed. A probability value of less than 0.05 will be considered statistically significant.

Keywords

Body mass index, Diet, Exercise, Polycystic ovarian syndrome, Physical activity

In 1935, Irving Stein and Michael Leventhal coined the term PCOS also known as “Stein-Leventhal Syndrome,” to refer to the trio of “Amenorrhea,” “Obesity,” and “Hirsutism” (1). In 2017, estimates of PCOS prevalence worldwide ranged from 5.5% to 12.6% (2), while estimates for India in 2018 varied from 8.2% to 22.50% (3). PCOS is an endocrine disorder that primarily affects females between the ages of 17 and 45 who are fertile. It is heterogeneous in nature and is characterised by Hirsutism, irregular menstruation, chronic anovulation, hyperandrogenism, and central obesity. Additionally, it can cause acne and metabolic abnormalities such as insulin resistance, hyperinsulinemia, dyslipidemia, and adiposity (4). PCOS has a negative impact on mental health, which may manifest as depression (5), social isolation and anxiety related to sexual dysfunction, which is eight times more common compared to women without the condition (6). All these physical and psychological factors ultimately lead to infertility (4).

Standard care for PCOS includes lifestyle modifications such as diet and physical exercises like aerobics, resistance training, aquatic therapy, Pilates, High-Intensity Interval Training (HIIT), yoga, and acupuncture, which have been proven to be effective in managing PCOS (7).

Calisthenics exercises, performed according to basic principles, involve rhythmic movements to enhance body strength and flexibility, providing health benefits with minimal risk of injury (8). This form of exercise is gaining popularity in recent years due to its nature where no equipment is required, and exercises are performed using one’s body weight. Studies reporting the combined effects of calisthenic exercise with either aerobic exercise or progressive resistive exercises have shown positive outcomes in PCOS (9),(10). However, the individual effects of a calisthenic exercise program in PCOS remain understudied. Furthermore, these combinations of exercises have been studied in PCOS women with higher BMI but not in those with normal BMI.

Yoga therapy is an emerging complementary and alternative medicine that has been proven effective in women with PCOS (11). Since the nature of calisthenics and yoga training is different, it was hypothesised that their effects would be distinct. Extensive literature search has revealed gaps in reporting the individualised effects of calisthenic exercise in PCOS and its comparative effects with yoga. Additionally, the residual effects at a 3-month follow-up are not well understood. Hence, the present study is being conducted to determine and compare the effects of calisthenic exercises and yoga in females with PCOS.

Objectives

To determine and compare the effects of calisthenic exercises and yoga on ultrasonography findings in terms of ovarian cyst count and size, lipid profile, anthropometric measurements, and health-related quality of life in women with PCOS.

Study Hypothesis

Alternate hypothesis (Ha): There will be a significant difference in the effects of calisthenic exercises and yoga on ultrasonography findings in terms of ovarian cyst count and size, ovarian volume, lipid profile, anthropometric measurements, and health-related quality of life in PCOS.

Null hypothesis (H0): There will be no significant difference in the effects of calisthenic exercises and yoga on ultrasonography morphology in terms of ovarian cyst count and size, ovarian volume, lipid profile, anthropometric measurements, and health-related quality of life in PCOS.

Review of Literature

Lifestyle modifications, such as diet and physical activity including aerobic exercises, progressive resistance exercises, aquatic exercises, pilates, HIIT yoga, and acupuncture, have been proven to be effective in managing PCOS (7). A systematic review and meta-analysis published in 2020 on exercise interventions in PCOS suggests that moderate to vigorous intensity exercise may have the greatest impact on cardiorespiratory fitness, body composition, and insulin resistance, with a minimum of 120 minutes of exercise per week to yield favourable health outcomes (12).

Calisthenics first appeared in ancient Greece. The Greek words “kallos” for beauty and “thenos” for strength are the origin of the word “calisthenics” (13). Calisthenics exercises are a type of exercise consisting of a variety of simple, often rhythmic movements intended to increase body strength and flexibility (8). Studies in the literature describe the beneficial effects of calisthenics exercises on body composition, flexibility, aerobic capacity, leg strength, blood pressure, resting pulse, total cholesterol, triglycerides, systolic and diastolic blood pressure, decrease in BMI, and improvement in bone mineral density (8),(13),(14).

Yoga has been practiced since before the Vedic era. It is a form of mind-body medicine that unites the physical, mental and spiritual aspects and promotes overall wellness (15). Yoga is advantageous for enhancing the body’s biochemical processes and lowering metabolic risk factors (16). Yoga facilitates blood flow and oxygen delivery to cells and reproductive tissues, builds muscle strength and flexibility, lowers cortisol and testosterone levels, balances sex hormones, and regularises menstruation (16),(17).

Material and Methods

A randomised controlled trial will be conducted in KLES Dr. Prabhakar Kore Hospital & Medical Research Centre, Belagavi, Obstetrics & Gynaecology Physiotherapy Outpatient Department (OPD). The duration of the study will be 4 years from June 2022 to August 2026. Recruitment of the participants will be conducted over a period of upto 30 months. Participants in this trial will be randomly assigned to one of two groups, with each group consisting of 51 participants, in an open-label, parallel-armed, double-blinded trial. Participants will be invited through advertisements and screening camps.

The research reference number KAHER/EC/22-23/ has been accepted by KLE University’s ethics board for the study involving individuals. The study is registered under CTRI number CTRI/2023/02/049579, registered in January 2023. Informed written consent will be obtained from each participant in the prescribed format prior to the performance of study-related procedures (e.g., physical examination, laboratory screening, or any other investigational procedure). Participants will receive full information about the study, including a description of any foreseeable risks and discomforts. They will also be informed of their right to opt out of the study at any time without providing any reasons.

Inclusion criteria: The participants will be women diagnosed with PCOS according to the 2003 Rotterdam criteria (18), aged between 18 and 35 years, including both nulliparous and multiparous women, who are willing to adhere to the treatment plan recommendations for the duration of the trial.

Exclusion criteria: Based on ACSM guidelines, participants with exercise contraindications will be excluded (19). Participants with associated co-morbid conditions such as diabetes mellitus, hypertension, endocrine disorders, cardiovascular disorders, cancer, tumours, etc., as well as pregnant women, those with physical disabilities, women on any medical management for PCOS or infertility treatment, and those currently on any form of exercise protocol, will be excluded from the study.

Sample size Estimation: The necessary sample size was determined using the results of a prior study that considered PCOSQ and BMI (10).

Sample Size at 95% Confidence Interval & 95% of Power

n=(Z1-α/2+Z1-β)2 (SD12+SD22)/(x1-x2)2

Z1-α/2=1.96 SD1=4.65 x1=21.50
Z1-β=1.64 SD2=3.54 x2=24.46

n=51

Required sample size: Hence, the required sample size was calculated as 50.52 x 2=101.46

Total sample size is 51+51=102

Recruitment: Attraction strategies will include flyers, advertisements, and screening events held at community centers and universities. Qualified participants will be provided with a comprehensive explanation of the study upon evaluation.

Randomisation: Group treatment will be conducted with participants randomly assigned to either yoga or calisthenics groups, with ten to twelve people in each group, depending on the location where they live. The groups will be assigned through block randomisation in a 1:1 ratio.

Blinding: Double-blinding will be used during the trial. Participants and the investigator will be blinded to the research groups.

The study protocol is reported in accordance with the SPIRIT reporting criteria for protocol studies (20). Statements from CONSORT-2010: Guidelines for Feasibility Trials and Extension to Pilot Studies have been cited in order to enhance trial reporting (Table/Fig 1).

After being divided into two groups at random, participants will be invited in groups at a designated time and day. They will be instructed about the equipment needed for the workouts, such as mats, shoes, clothes, etc. The warming-up and cooling-down phases of each intervention are scheduled first. The yoga and calisthenic exercise sessions will take place in a spacious recreation area.

Callisthenic Exercise

There will be a licensed physiotherapist leading the sessions. A total of 51 participants will receive supervised group therapy, with each group session consisting of 8-12 people. According to ACSM guidelines for exercise (19), intensity will be prescribed and maintained between 60-70% of the maximum heart rate (HR Max= 220- age). Participants will perform five sessions of calisthenic exercises per week for six weeks. Each session will include a 5-minute warm-up, a 45-minute calisthenic exercise session, and a 10-minute cool-down, totaling 60 minutes per session. The exercise protocol is registered with the Copyrights Office of the Government of India with registration number L-138873/2023.

Yoga Group

Sessions will be led by a licensed yoga instructor. An orientation workshop session will be conducted for study participants before commencing the intervention, where they will be explained in detail about the study protocol. Supervised group therapy will be provided, with each group consisting of 8-12 participants. Over a period of six weeks, a total of five intervention sessions will be conducted each week. The yoga program will consist of a 60-minute session, including warm-up, yoga poses, pranayama, and cool-down.

Diet Program

The diet plan will be prepared by a licensed nutritionist. Study participants will receive a printed diet plan to follow for a period of six weeks. Participants in both groups will be provided with a diet modification chart that includes high-protein and low-carbohydrate foods, with calorie intake restricted to 1200-1500 calories per day.

Relevant concomitant care: Until the trial is over, participants will be instructed to abstain from all drugs, other types of exercise, and weight-loss regimens.

Adherence to interventions: Every two weeks, the daily exercise attendance log book and diet will be examined and maintained throughout the study.

Criteria for Dropouts

- Participants not complying with 70-75% attendance,
- Missing more than 10 sessions
- Participants who are not able to carry out the exercise due to a personal or medical condition.
- Any medical emergency or worsening of pre-existing concurrent medical conditions that the subject encounters during the study period.

Criteria for protocol modifications/discontinuation: The protocol will be amended or modified only in the event of an unfavourable occurrence or a practical obstacle encountered during the trial’s conduct. If any changes occur, the Research Ethical Committee will be informed of the modifications and the request for permission.

Data Collecting Procedures

A licensed physiotherapist who is blinded to the group assignment will conduct the outcome assessments. Age, co-morbidities, age at menarche, menstrual cycle information, and other demographics will be recorded (Table/Fig 2).

Outcomes

1. Ultrasonography Scan (21): A gynaecologist will perform ultrasonography using either a trans-vaginal probe or a trans-abdominal probe scanning method. Measurements of the number and size of ovarian cysts, as well as their volume, will be collected before the intervention (T0) and six weeks after (T1).

2. Lipid profile: The lipid profile will be measured at pre-intervention (T0) and in the sixth week post-intervention (T2), including triglycerides, HDL, and LDL levels.

3. Anthropometric Measurements:

a. Body Mass Index (BMI) (22): BMI is calculated by dividing a participant’s weight in kilograms (or pounds) by the square of their height in meters (or feet). BMI will be measured pre-intervention (T0), at six weeks post-intervention (T1), and during the 12-week follow-up (T2).

b. Waist Hip Ratio (23): With participants standing, the circumference of the waist will be measured using a non-stretch fibre tape in centimetres. To ensure accuracy, the measurement will be taken one centimetre above the umbilicus during full expiration. The nearest 1 centimetre will be used for rounding decimals. Measurements of waist circumference will be taken before the intervention (T0), six weeks after the intervention (T1), and again after the 12-week mark (T2).

4. Polycystic Ovarian Syndrome Questionnaire (PCOSQ-26) (24): This is a common, trustworthy, and legitimate tool for assessing the health-related quality of life (HRQOL) of women with PCOS. The questionnaire consists of 26 items categorised into emotions (8 items), body hair (5 items), weight (5 items), problems with infertility (4 items), and problems with menstruation (4 items). It will be evaluated six weeks following the intervention (T1), before the intervention (T0), and during the 12-week follow-up (T2).

Safety monitoring: The expected adverse events will include fatigue, sprains, joint pain, breathlessness, etc. In the event of an unfavourable incident, the participant will be eliminated after consulting the Ethical Review Committee. The individual will be transferred for further investigation and oversight.

Administration of data: To ensure anonymisation, the information will be recorded and entered into an Excel file. The lead investigator will be the only individual with access to these records, which will be securely stored. The statistician will remain blinded by assigning the intervention groups A and B. Without participant coding or de-identification, data cannot be accessed by anyone.

Confidentiality: The confidentiality and privacy of the study participants’ personal information will be maintained. Scientific articles and presentations containing a codified version of the group data will be made available. The information will be digitally secured and password-protected. In the unlikely event that participants’ photos are published, the authors will take measures to protect their identities and ensure their names are not disclosed.

Planned Statistical Methods

Statistical methods: SPSS software version 29.0 (SPSS, Inc., Chicago, IL, USA) will be used for the statistical analysis. For the collected data, both descriptive and inferential statistical analyses will be applied. Standard deviation and mean will be used to present quantitative variables. A test for normality distribution will be conducted to determine whether non-parametric tests (the Mann-Whitney U test or the Wilcoxon signed-rank test) or parametric tests (the Z test and/or ANOVA) should be performed. The intention-to-treat concept will be used in the primary impact analysis. Statistical significance will be determined by a probability value of less than 0.05.

Acknowledgement

The authors are thankful that the KAHER Institute of Physiotherapy and the KLE Dr. P K Hospital & M R C provided me with needed necessary facilities. The authors acknowledge the assistance of statistician Dr. (Prof) Prasad to calculate the sample size.

Disclosure statement: Ultrasonography and lipid profile were sponsored by the Obstetrics & Gynaecology (OBG) Department and the laboratory department of KLES Dr. PK Hospital & MRC, Belagavi, India with 40% discounted charges. The sponsor did not and will not contribute to the study’s conception, design, writing of the protocol, or publication. Additionally, they have no stake in the study’s findings or conclusions. Their influence does not affect the writers’ choice to submit the work for publication. The writers express gratitude to their sponsors for their support.

References

1.
Stein IF, Leventhal ML. Amenorrhea associated with bilateral polycystic ovaries. Am J Obstet Gynecol. 1935;29(2):181-85. Doi: 10.1016/s0002-9378(15)30642-6. [crossref]
2.
Ding T, Hardiman PJ, Petersen I, Wang FF, Qu F, Baio G. The prevalence of polycystic ovary syndrome in reproductive-aged women of different ethnicity: A systematic review and meta-analysis. Oncotarget. 2017;8(56):96351-58. Doi: 10.18632/oncotarget.19180. [crossref][PubMed]
3.
Gupta M, Singh D, Toppo M, Priya A, Sethia S, Gupta P. A cross sectional study of polycystic ovarian syndrome among young women in Bhopal, Central India. Int J Community Med Public Health. 2017;5(1):95-100. Doi:10.18203/2394-6040. ijcmph20175603. [crossref]
4.
Singh S, Pal N, Shubham S, Sarma DK, Verma V, Marotta F, et al. Polycystic ovary syndrome: Etiology, current management, and future therapeutics. J Clin Med. 2023;12(4):1454. Doi: 10.3390/jcm12041454. [crossref][PubMed]
5.
Chaudhari AP, Mazumdar K, Mehta PD. Anxiety, depression, and quality of life in women with polycystic ovarian syndrome. Indian J Psychol Med. 2018;40(3):239-46. Doi: 10.4103/IJPSYM.IJPSYM_561_17. PMID: 29875531; PMCID: PMC5968645. [crossref][PubMed]
6.
Costa EC, Soares EM, Lemos TM, Maranhão TM, Azevedo GD. Central obesity index and cardiovascular risk factors in polycystic ovary syndrome. Arq Bras Cardiol. 2010;94(5):633-38. [crossref][PubMed]
7.
Kite C, Lahart IM, Afzal I, Broom DR, Randeva H, Kyrou I, et al. Exercise, or exercise and diet for the management of polycystic ovary syndrome: A systematic review and meta-analysis. Syst Rev. 2019;8(1):51. Doi: 10.1186/s13643-019-0962-3. [crossref][PubMed]
8.
Santhosh R, Abraham Davidson S. Effect of calisthenics exercise on selected motor fitness variables among slum boys during COVID-19. J Xi'an Shiyou Univ Nat Sci Ed. 2021;17(4):163-68. Available from: https://www.xisdxjxsu.asia/V17I4-14.pdf.
9.
Vizza L, Smith CA, Swaraj S, Agho K, Cheema BS. The feasibility of progressive resistance training in women with polycystic ovary syndrome: A pilot randomized controlled trial. BMC Sports Sci Med Rehabil. 2016;8(1):14. Doi: 10.1186/ s13102-016-0039-8. [crossref][PubMed]
10.
Kirthika V, Paul J, Selvam S, Priya VS. Effect of progressive resisted exercises and aerobic exercises in the management of polycystic ovarian syndrome among young women- A pilot randomized controlled trial. Biomedicine. 2020;39(4):608- 12. Doi:10.51248/. v39i4.142. [crossref]
11.
Thakur D, Singh SS, Tripathi M. Effect of yoga on polycystic ovarian syndrome: A systematic review. J Bodyw Mov Ther. 2021;27:281-86. Doi: 10.1016/j. jbmt.2021.02.018. [crossref][PubMed]
12.
Patten RK, Boyle RA, Moholdt T, Kiel I, Hopkins WG, Harrison CL, et al. Exercise interventions in polycystic ovary syndrome: A systematic review and meta-analysis. Front Physiol. 2020;11:606. Doi: 10.3389/fphys.2020.00606. [crossref][PubMed]
13.
Rajeev S, Vikram S, Srivastava R, Sakthignanavel, Head, Singh V. Effect of pilates exercise calisthenics exercise and combination of pilates and calisthenics exercise on flexibility & strength of school boys. International Journal of Movement Education and Social Science. 2013;2(2):75-77.
14.
Preisinger E, Kerschan-Schindl K, Wöber C, Kollmitzer J, Ebenbichler G, Hamwi A, et al. The effect of callisthenic home exercises on postmenopausal fractures-A long-term observational study. Maturitas. 2001;40(1):61-67. Doi: 10.1016/ s0378-5122(01)00229-8. [crossref][PubMed]
15.
Collins C. Yoga: Intuition, preventive medicine, and treatment. J Obstet Gynecol Neonatal Nurs. 1998;27(5):563-68. Doi: 10.1111/j.1552-6909. 1998.tb02623.x. [crossref][PubMed]
16.
Shalini B, Elangovan R. Efficacy of yoga therapy on body mass index and testosterone among adult women with polycystic ovarian syndrome. European Journal of Molecular & Clinical Medicine. 2020;7(09):1103-09. Doi: 10.31838/ Ejmcm.07.09.114. [crossref]
17.
Patel V, Menezes H, Menezes C, Bouwer S, Bostick-Smith CA, Speelman DL. Regular mindful yoga practice as a method to improve androgen levels in women with polycystic ovary syndrome: A randomized, controlled trial. J Am Osteopath Assoc. 2020;120(5):323-35. Available from: https://doi.org/10.7556/ jaoa.2020.050. [crossref][PubMed]
18.
Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-47. Doi: 10.1093/humrep/deh098. [crossref][PubMed]
19.
Liguori G, American College of Sports Medicine (ACSM). ACSM's Guidelines for Exercise Testing and Prescription. 11th ed. Philadelphia: Lippincott Williams & Wilkins; 2021.
20.
Chan A-W, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: Guidance for protocols of clinical trials. BMJ. 2013;346:e7586. Doi: 10.1136/bmj.e7586. [crossref][PubMed]
21.
Rocha MP, Marcondes JA, Barcellos CR, Hayashida SA, Curi DD. Dyslipidemia in women with polycystic ovary syndrome: Incidence, pattern and predictors. Gynecol Endocrinol. 2011;27(10):814-19. [crossref][PubMed]
22.
Mohajan D, Mohajan HK. Body mass index (BMI) is a popular anthropometric tool to measure obesity among adults. Journal of Innovations in Medical Research. 2023;2(4):25-33. Doi: 10.56397/jimr/2023.04.06. [crossref]
23.
Misra A, Vikram NK, Gupta R, Pandey RM, Wasir JS, Gupta VP. Waist circumference cut-off points and action levels for Asian Indians for identification of abdominal obesity. Int J Obes (Lond). 2006;30(1):106-11; Doi: 10.1038/ sj.ijo.0803111. [crossref][PubMed]
24.
Cronin L, Guyatt G, Griffith L, Wong E, Azziz R, Futterweit W, et al. Development of a health-related quality-of-life questionnaire (PCOSQ) for women with polycystic ovary syndrome (PCOS). J Clin Endocrinol Metab. 1998;83(6):1976- 87. Doi: 10.1210/jcem.83.6.4990.[crossref][PubMed]

DOI and Others

DOI: 10.7860/JCDR/2024/70336.19725

Date of Submission: Apr 19, 2024
Date of Peer Review: May 04, 2024
Date of Acceptance: Jun 12, 2024
Date of Publishing: Aug 01, 2024

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was informed consent obtained from the subjects involved in the study? NA
• For any images presented appropriate consent has been obtained from the subjects. NA

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Apr 22, 2024
• Manual Googling: May 08, 2024
• iThenticate Software: Jun 11, 2024 (6%)

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