Clinical trial NCT05651568: Effect of Periodized Resistance Training and High Intensity Training on BMI and QOL in PCOS
Official title: Comparison of Periodized Resistance Training and High Intensity Interval Training on Body Mass Index and Quality of in Polycystic Ovarian Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 26
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study may help to improve strength and body composition in females with PCOS. It will enhance ability of an overweight individual to perform functional tasks (i.e. daily living tasks or physical activity) to be physically active. This may facilitate the adoption of a more active lifestyle, thereby increasing the likelihood of success in overall weight-reduction strategies.

Detailed description: Poly cystic ovarian syndrome (PCOS) is a hormonal disorder which is most common in females with fertile age. A number of small fluid filled sacs formed in ovaries which results in failure of egg release. Poly cystic ovary syndrome (PCOS) is an endocrine problem which is characterized by the polycystic ovaries, menstrual problems, infertility, metabolic disorder, psychological problems, elevated androgens, hirsutism, acne and obesity. PCOS also causes psychological disorders which include depression, anxiety, poor body image, low self-esteem and decreased health- related quality of life. Some well-controlled randomized clinical studies have been conducted to evaluate the effects of exercise training program in women with PCOS. There are many beneficial effects of exercises which improve physical fitness, body composition, and cardiovascular, hormonal, reproductive and psychological outcomes. Periodization training program involves period of active rest which allows muscle adaptations through variable intensity, volume and rest. The advantage of periodization is that it prevent from overtraining symptoms such as muscle stiffness, muscle soreness, sprain, strain, possible injury and decreased performance. High intensity interval training is effective in reducing body mass index and improving body composition in females with PCOS.

The study will be a randomized clinical trial and will be conducted in Mohsin memorial hospital Faisalabad. This study will be completed in time duration of ten months after the approval of synopsis and convenient sampling technique will be used. Total twenty four subjects will be assigned randomly by using lottery method into two groups. Group A will receive periodized resistance training and Group B will receive high intensity interval training. Warm up and cool down period of ten minutes of treadmill training will be performed by both groups. Data will be collected from all participants at baseline and after 8 weeks of treatment by using BMI and WHO-QOL BREF questionnaire. After assessing the normality data will be analyzed by using parametric or non-parametric test by using SPSS-25.

Eligibility criteria: Inclusion Criteria:

* Age between 20-35 years
* Unmarried females
* Diagnosed patients of PCOS
* All women who are less physically active or have sedentary life style.
* BMI\>25kg/m2 (overweight obese)

Exclusion Criteria:

* Use of hormonal contraceptives.
* Diabetes
* Hypertension
* Thyroid disease
* Cushing disease
* Any physical disability

Primary outcomes:
measure: Body Mass Index
timeFrame: 8th week
measure: WHO quality of life Bref
timeFrame: 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: PSRD
state: Punjab
Study officials:
affiliation: Riphah International University
name: Adeela Arif, Mphil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christodoulopoulou V, Trakakis E, Pergialiotis V, Peppa M, Chrelias C, Kassanos D, Papantoniou N. Clinical and Biochemical Characteristics in PCOS Women With Menstrual Abnormalities. J Family Reprod Health. 2016 Dec;10(4):184-190.
citation: Venkatesh SS, Ferreira T, Benonisdottir S, Rahmioglu N, Becker CM, Granne I, Zondervan KT, Holmes MV, Lindgren CM, Wittemans LBL. Obesity and risk of female reproductive conditions: A Mendelian randomisation study. PLoS Med. 2022 Feb 1;19(2):e1003679. doi: 10.1371/journal.pmed.1003679. eCollection 2022 Feb.
citation: Jobanputra H, Pawar V, Guhe A, Kalambe SRNM, Chaudhary A. Polycystic Ovarian Syndrome with Physical Therapy Management and A Proof-Primarily Based Totally Evaluation Article for Exercise in Pcos. NVEO-NATURAL VOLATILES & ESSENTIAL OILS Journal| NVEO. 2021:1370-81.
citation: Clemente-Suarez VJ, Ramos-Campo DJ. Effectiveness of Reverse vs. Traditional Linear Training Periodization in Triathlon. Int J Environ Res Public Health. 2019 Aug 6;16(15):2807. doi: 10.3390/ijerph16152807.