Effects of Senobi Exercise & Aerobic Exercises in Polycystic Ovarian Syndrome

Официальное название

Combine Effects of Senobi Exercise & Aerobic Exercises on Body Mass Index, Fatigue and Quality of Life in Polycystic Ovarian Syndrome.

Обзор

One of the most prevalent endocrine system conditions affecting women of reproductive age is polycystic ovary syndrome (PCOS), also known as hyperandrogenic anovulation (HA) or Stein-Leventhal syndrome. This chronic and heterogeneous disorder manifests itself as menstrual dysfunction, infertility, hirsutism, acne, and obesity. This study will be randomized controlled trial and will be conducted in Qasim Sandhu medical complex, Iiffat Anwar Medical Complex and OMC Hospital Lahore. Data will be collected 10 months after approval of synopsis. The total duration of treatment will be 6 weeks. Non-probability convenience sampling technique will be used and 32 participants will be recruited in study after randomization according to selection criteria. The subjects will be divided into two groups, 16 participants in each group. Group A (experimental group) will receive senobi exercises and aerobic exercises, 3 days\\week for 6 weeks and Group B (control group) will receive aerobic exercises, 3days\\week for 6 week.

Подробное описание

One of the most prevalent endocrine system conditions affecting women of reproductive age is polycystic ovary syndrome (PCOS), also known as hyperandrogenic anovulation (HA) or Stein-Leventhal syndrome. This chronic and heterogeneous disorder manifests itself as menstrual dysfunction, infertility, hirsutism, acne, and obesity. It is usually only diagnosed when complications develop that significantly reduce a patient's quality of life (e.g., hair loss, alopecia, acne, and infertility-related problems). The World Health Organization (WHO) estimates that in 2012 PCOS affected 116 million women globally. Although PCOS can occur at any age, beginning with menarche, the majority of instances are identified between the ages of 20 and 30. Polycystic ovary syndrome (PCOS) is an important and highly prevalent obesity-related comorbidity that develops in girls and women who are genetically predisposed to its development. This study will be randomized controlled trial and will be conducted in Qasim Sandhu medical complex, Iiffat Anwar Medical Complex and OMC Hospital Lahore. Data will be collected 10 months after approval of synopsis. The total duration of treatment will be 6 weeks. Non-probability convenience sampling technique will be used and 32 participants will be recruited in study after randomization according to selection criteria. The subjects will be divided into two groups, 16 participants in each group. Group A (experimental group) will receive senobi exercises and aerobic exercises, 3 days\\week for 6 weeks and Group B (control group) will receive aerobic exercises, 3days\\week for 6 week. Nutritional counselling and deep breath for 5 minutes will be used as Baseline treatment. The tools that will be used are BMI Calculator for obesity, WHQOL-BREF Questionnaire for Quality of life and multidimensional fatigue inventory (MFI) questionnaire to assess fatigue. After data collection data will be analyzed by using SPSS version 25.

Вмешательства

• Другое Senobi exercises with aerobics exercises
  The participants in group A will receive interventional treatment (senobi exercises), 3 days a week for 6 weeks as a supervised exercise program, as well as they will receive aerobic exercises on treadmill with 10% grade and 5mph speed for 20 minutes a session with 5 minutes of warm up and 5 minutes of cool down of total 30 minutes a session, 5 sessions for a week for 6 weeks. Baseline treatment for both groups will be deep Breathing exercise- 5 reps/3 seconds inspiration 6 seconds expiration/1
• Другое aerobic exercises
  The participants in group B will receive aerobic exercises on treadmill with 10% grade and 5mph speed for 20 minutes a session with 5 minutes of warm up and 5 minutes of cool down of total 30 minutes a session, 5 sessions for a week for 6 weeks. Subjects will be assessed at baseline and after 6 weeks. The post-interventional assessment will be taken and the results will be interpreted. Baseline treatment for both groups will be deep Breathing exercise- 5 reps/3 seconds inspiration 6 seconds expi

Первичные конечные точки

• WHQOL-BREF Questionnaire [Срок оценки: 6 weeks]
• Multidimensional fatigue inventory [Срок оценки: 6 weeks]
• Body Mass Index [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• Women between the Ages of 18 to 35 Diagnosed with PCOS Menstrual disturbance > 3 months BMI of 29-35kg/m Unmarried and married with multiparous

Критерии исключения

• Women with other causes of menstrual disturbances (ovarian cancer) Known cardiovascular problems (cardiac arrhythmias) Uncontrolled hypertension or low blood pressure Presence of neurological disease (epilepsy, autism) Orthopedic illness (rheumatoid arthritis, osteoporosis) Cardiopulmonary disease (CVD, COPD) Musculoskeletal injuries (fracture, tendon rupture) Antiobesity medications

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Riphah International University, Lahore — Lahore

Публикации

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• Barber TM, Franks S. Obesity and polycystic ovary syndrome. Clin Endocrinol (Oxf). 2021 Oct;95(4):531-541. doi: 10.1111/cen.14421. Epub 2021 Jan 31. PMID 33460482
• Norman RJ, Dewailly D, Legro RS, Hickey TE. Polycystic ovary syndrome. Lancet. 2007 Aug 25;370(9588):685-97. doi: 10.1016/S0140-6736(07)61345-2. PMID 17720020
• Merkin SS, Phy JL, Sites CK, Yang D. Environmental determinants of polycystic ovary syndrome. Fertil Steril. 2016 Jul;106(1):16-24. doi: 10.1016/j.fertnstert.2016.05.011. Epub 2016 May 27. PMID 27240194
• Lujan ME, Chizen DR, Pierson RA. Diagnostic criteria for polycystic ovary syndrome: pitfalls and controversies. J Obstet Gynaecol Can. 2008 Aug;30(8):671-679. doi: 10.1016/S1701-2163(16)32915-2. PMID 18786289
• Hashemipour M, Amini M, Iranpour R, Sadri GH, Javaheri N, Haghighi S, Hovsepian S, Javadi AA, Nematbakhsh M, Sattari G. Prevalence of congenital hypothyroidism in Isfahan, Iran: results of a survey on 20,000 neonates. Horm Res. 2004;62(2):79-83. doi: 10.1159/000079392. Epub 2004 Jun 24. PMID 15237248
• Liu J, Wu Q, Hao Y, Jiao M, Wang X, Jiang S, Han L. Measuring the global disease burden of polycystic ovary syndrome in 194 countries: Global Burden of Disease Study 2017. Hum Reprod. 2021 Mar 18;36(4):1108-1119. doi: 10.1093/humrep/deaa371. PMID 33501984
• Bremer AA. Polycystic ovary syndrome in the pediatric population. Metab Syndr Relat Disord. 2010 Oct;8(5):375-94. doi: 10.1089/met.2010.0039. PMID 20939704

Идентификаторы

NCT: NCT07328048 · Syeda Iram Shahzadi

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗