search
Back to results

Effect of Periodized Resistance Training and High Intensity Training on BMI and QOL in PCOS

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Periodized resistance training
High intensity interval training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • PSRD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Periodized resistance training

High intensity interval training

Arm Description

It consists of patients who will receive periodized resistance training 3 sessions per week for 8 weeks. Resistance training has been performed according to FITT principal and as per ACSM recommendation.

It consists of patients who will receive high intensity interval training 3 sessions per week for 8 weeks for 30-35 minutes.

Outcomes

Primary Outcome Measures

Body Mass Index
Body mass index is a screening tool derived from the weight and height of a person. It is a simple numeric measure of a subject"s thickness or thinness. Calculated values help in determining if a person is underweight, normal weight or overweight. Body mass index used to classify average sedentary (physically inactive) populations, with an average body composition. Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meters squared. A BMI of 25.0 or more is overweight, while the healthy range is 18.5 to 24.9.
WHO quality of life Bref
The WHOQOL- BREF is a 26 items self-report questionnaire consisting of 4 domains of quality of life. Physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains 2 items of overall QOL and general health.

Secondary Outcome Measures

Full Information

First Posted
December 7, 2022
Last Updated
June 14, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05651568
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
January 25, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Periodized resistance training
Arm Type
Experimental
Arm Description
It consists of patients who will receive periodized resistance training 3 sessions per week for 8 weeks. Resistance training has been performed according to FITT principal and as per ACSM recommendation.
Arm Title
High intensity interval training
Arm Type
Experimental
Arm Description
It consists of patients who will receive high intensity interval training 3 sessions per week for 8 weeks for 30-35 minutes.
Intervention Type
Other
Intervention Name(s)
Periodized resistance training
Intervention Description
It consists of patients who will receive periodized resistance training 3 sessions per week for 8 weeks. Resistance training has been performed according to FITT principal and as per ACSM recommendation. Frequency: Three days in a week Intensity: 60% intensity with one repetition maximum and 10% intensity were added each the two weeks.4 sets and 8-12 rep as per ACSM criteria. There will be rest of 60 second after every set and 120 seconds after every exercise. Type: 8 types of resistance exercises were performed. There were 4 set of each exercise with 8 to 12 repetitions. These exercises are smith press, seated press, squat, lying dumbbell leg curls, leg extension, leg press, standing barbell, lying barbell and sit ups. Time: 40 minutes per session.
Intervention Type
Other
Intervention Name(s)
High intensity interval training
Intervention Description
It consists of patients who will receive high intensity interval training 3 sessions per week for 8 weeks for 30 to 35 minutes. Active phase: Two weekly sessions of four times four minutes at 90-95% of individual heart rate maximum, separated by three minutes of active rest period and one weekly session of ten times one minute with maximal intensity, separated by one minute of active rest. The exercise mode will be treadmill or outdoor walking/running or cycling (self-selected).
Primary Outcome Measure Information:
Title
Body Mass Index
Description
Body mass index is a screening tool derived from the weight and height of a person. It is a simple numeric measure of a subject"s thickness or thinness. Calculated values help in determining if a person is underweight, normal weight or overweight. Body mass index used to classify average sedentary (physically inactive) populations, with an average body composition. Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meters squared. A BMI of 25.0 or more is overweight, while the healthy range is 18.5 to 24.9.
Time Frame
8th week
Title
WHO quality of life Bref
Description
The WHOQOL- BREF is a 26 items self-report questionnaire consisting of 4 domains of quality of life. Physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains 2 items of overall QOL and general health.
Time Frame
8th week

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeela Arif, Mphil
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
PSRD
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28546817
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.
Results Reference
background
PubMed Identifier
35104295
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. Erratum In: PLoS Med. 2022 Sep 2;19(9):e1004095.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
31390818
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.
Results Reference
background

Learn more about this trial

Effect of Periodized Resistance Training and High Intensity Training on BMI and QOL in PCOS

We'll reach out to this number within 24 hrs