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High Intensity Resistance and Aerobic Training Among Women With PCOS

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
High intensity resistance Exercise Training
High intensity aerobic Exercise 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

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Women diagnosed with PCOS according to Rotterdam criteria Age limit: 18-30 Women who are not part of planned physical activity for the last six months. BMI<=30 Exclusion Criteria: Women with PCOS who are already on birth control or hormone therapy. Women with PCOS who are already are taking some medication for psychological issues Women who are already taking cholesterol control medications. Women who are a part of any physical activity already

Sites / Locations

  • PostGraduate Lab FRAHS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

High Intensity Resistance Training

High Intensity Aerobic Training

Arm Description

This group will perform high intensity resistance training under supervised physiotherapist in a gym setting. The training load for the first 2 weeks will be 60%-75% of 1RM and increased to 75%-90% of 1RM the following weeks. Load would be increased if the participants will be able to perform 3 sets of 12 repetitions with that load.

This group will perform aerobic training under supervision of a physical therapist in gym setting. To calculate exercise intensity, the HR will be maintained at 75-90% of the maximum (HRmax). The training protocol will begin with a 5-minute warm-up and will end with a 5-minute cool down, during which the HR will be 60-75% of the HRmax. At least 90 min of exercise per week for obese PCOS patients, with treadmill walking that may include whole-body movement involving more than 2/3 of the muscles, the exercise intensity will be high intensity

Outcomes

Primary Outcome Measures

Body Mass Index
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
Body Mass Index
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
Body Mass Index
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
Waist Hip Ratio
The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips
Waist Hip Ratio
The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips
Waist Hip Ratio
The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips
Polycystic ovarian syndrome questionnaire (PCOSQ)
The PCOSQ consists of five domains, each relating to a common symptom of PCOS; body hair, emotions, infertility, menstrual problems and infertility. Each question on the PCOSQ is associated with a 7-point scale in which 7 represents optimal function and 1 the poorest function.
Polycystic ovarian syndrome questionnaire (PCOSQ)
The PCOSQ consists of five domains, each relating to a common symptom of PCOS; body hair, emotions, infertility, menstrual problems and infertility. Each question on the PCOSQ is associated with a 7-point scale in which 7 represents optimal function and 1 the poorest function.
SF-36 QOL
The SF-36 is a generic patient-reported outcome measure that quantifies health status and measures health-related quality of life.The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)
SF-36 Quality of life
The SF-36 is a generic patient-reported outcome measure that quantifies health status and measures health-related quality of life.The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)

Secondary Outcome Measures

LH/FSH ratios
Luteinizing hormone (LH), follicle-stimulating hormone (FSH), and LH/FSH ratio will be measured when considering a PCOS diagnosis. The LH/FSH ratio is a valid and frequently employed method to test the ovulation and menstrual health of such women and have been reported by many studies

Full Information

First Posted
October 28, 2022
Last Updated
May 17, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05603169
Brief Title
High Intensity Resistance and Aerobic Training Among Women With PCOS
Official Title
Effects of High Intensity Resistance and Aerobic Training Among Women With Polycystic Ovarian Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
May 10, 2023 (Actual)
Study Completion Date
May 10, 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
polycystic ovarian syndrome (PCOS) is the most common endocrine female disorder, affecting 4-18% women of reproductive age. The prevalence of PCOS in South Asian women, especially in Pakistani women, is much higher (52%) as compared to white population (20 - 25% in UK). On the basis of cultural, environment, diet and lifestyle practices these women are more prone to development of such disorder. So such public health issue needs to be addressed by strong evidence conducted by a clinical trial. The current study is planned to compare effects of two different exercise protocols of high intensity on anthropometric measures, hormonal profile and quality of life.
Detailed Description
PCOS is a prevalent condition that is affecting adolescent girls now and has serious impacts on menstrual health and quality of life making them prone to early risk development for chronic metabolic diseases. The comparison between high intensity resistance and aerobic training would give results that which one is more effective in gaining benefits and better effects on overall health both physically(menstrual) as well as mentally that would eventually tell us about the quality of life of such patients. After the initial screening process, the participants fulfilling the Roterdam criteria, willing to participate in the exercise trial will be recruited and then randomized to the allocated groups of either high intensity resistance or high intensity aerobics. At baseline, their anthropometrics measurements, LH/FSH ratios and fasting plasma glucose test will be done. Patient will be called thrice a week for 3 months for training. It is hypothesized that high intensity resistance or high intensity aerobics will improve anthropometric measures along with hormonal profile and quality of life.

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
Model Description
Parallel assignment into two groups
Masking
Outcomes Assessor
Masking Description
Assessor of this study will be kept blind of the participants treatment group
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Resistance Training
Arm Type
Active Comparator
Arm Description
This group will perform high intensity resistance training under supervised physiotherapist in a gym setting. The training load for the first 2 weeks will be 60%-75% of 1RM and increased to 75%-90% of 1RM the following weeks. Load would be increased if the participants will be able to perform 3 sets of 12 repetitions with that load.
Arm Title
High Intensity Aerobic Training
Arm Type
Active Comparator
Arm Description
This group will perform aerobic training under supervision of a physical therapist in gym setting. To calculate exercise intensity, the HR will be maintained at 75-90% of the maximum (HRmax). The training protocol will begin with a 5-minute warm-up and will end with a 5-minute cool down, during which the HR will be 60-75% of the HRmax. At least 90 min of exercise per week for obese PCOS patients, with treadmill walking that may include whole-body movement involving more than 2/3 of the muscles, the exercise intensity will be high intensity
Intervention Type
Other
Intervention Name(s)
High intensity resistance Exercise Training
Intervention Description
The resistance training will consist of five resistance exercises (thrice a week on non-consecutive days): squat, leg press, knee extension, lunges, and abdominal crunches. Every participant will be assessed pre and post intervention for hormonal change, BMI/anthropometric measures, fasting glucose and quality of life.The plan will be followed for 12 weeks
Intervention Type
Other
Intervention Name(s)
High intensity aerobic Exercise Training
Intervention Description
The training protocol will begin with a 5-minute warm-up and will end with a 5-minute cool down, during which the HR will be 60-75% of the HRmax. At least 90 min of exercise per week for obese PCOS patients, with treadmill walking that may include whole-body movement involving more than 2/3 of the muscles, the exercise intensity will be high intensity
Primary Outcome Measure Information:
Title
Body Mass Index
Description
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
Time Frame
changes from Baseline to 4 weeks
Title
Body Mass Index
Description
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
Time Frame
changes from 4 weeks to 8weeks
Title
Body Mass Index
Description
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
Time Frame
changes from 8 weeks to 12 weeks
Title
Waist Hip Ratio
Description
The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips
Time Frame
changes from Baseline to 4 weeks
Title
Waist Hip Ratio
Description
The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips
Time Frame
changes from 4 weeks to 8weeks
Title
Waist Hip Ratio
Description
The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips
Time Frame
changes from 8 weeks to 12 weeks
Title
Polycystic ovarian syndrome questionnaire (PCOSQ)
Description
The PCOSQ consists of five domains, each relating to a common symptom of PCOS; body hair, emotions, infertility, menstrual problems and infertility. Each question on the PCOSQ is associated with a 7-point scale in which 7 represents optimal function and 1 the poorest function.
Time Frame
changes from Baseline to 6 weeks
Title
Polycystic ovarian syndrome questionnaire (PCOSQ)
Description
The PCOSQ consists of five domains, each relating to a common symptom of PCOS; body hair, emotions, infertility, menstrual problems and infertility. Each question on the PCOSQ is associated with a 7-point scale in which 7 represents optimal function and 1 the poorest function.
Time Frame
changes from 6 weeks to 12 weeks
Title
SF-36 QOL
Description
The SF-36 is a generic patient-reported outcome measure that quantifies health status and measures health-related quality of life.The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)
Time Frame
changes from Baseline to 6 weeks
Title
SF-36 Quality of life
Description
The SF-36 is a generic patient-reported outcome measure that quantifies health status and measures health-related quality of life.The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)
Time Frame
changes from 6 weeks to 12 weeks
Secondary Outcome Measure Information:
Title
LH/FSH ratios
Description
Luteinizing hormone (LH), follicle-stimulating hormone (FSH), and LH/FSH ratio will be measured when considering a PCOS diagnosis. The LH/FSH ratio is a valid and frequently employed method to test the ovulation and menstrual health of such women and have been reported by many studies
Time Frame
changes from Baseline to 3 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women diagnosed with PCOS according to Rotterdam criteria Age limit: 18-30 Women who are not part of planned physical activity for the last six months. BMI<=30 Exclusion Criteria: Women with PCOS who are already on birth control or hormone therapy. Women with PCOS who are already are taking some medication for psychological issues Women who are already taking cholesterol control medications. Women who are a part of any physical activity already
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huma Riaz
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
PostGraduate Lab FRAHS
City
Islamabad
State/Province
Fedral
ZIP/Postal Code
04486
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33638879
Citation
Benham JL, Booth JE, Corenblum B, Doucette S, Friedenreich CM, Rabi DM, Sigal RJ. Exercise training and reproductive outcomes in women with polycystic ovary syndrome: A pilot randomized controlled trial. Clin Endocrinol (Oxf). 2021 Aug;95(2):332-343. doi: 10.1111/cen.14452. Epub 2021 May 3.
Results Reference
background
PubMed Identifier
33467251
Citation
Shele G, Genkil J, Speelman D. A Systematic Review of the Effects of Exercise on Hormones in Women with Polycystic Ovary Syndrome. J Funct Morphol Kinesiol. 2020 May 31;5(2):35. doi: 10.3390/jfmk5020035.
Results Reference
background
PubMed Identifier
27771865
Citation
Mario FM, Graff SK, Spritzer PM. Habitual physical activity is associated with improved anthropometric and androgenic profile in PCOS: a cross-sectional study. J Endocrinol Invest. 2017 Apr;40(4):377-384. doi: 10.1007/s40618-016-0570-1. Epub 2016 Oct 22.
Results Reference
background
PubMed Identifier
34567361
Citation
Wright PJ, Corbett CF, Pinto BM, Dawson RM, Wirth M. Resistance Training as Therapeutic Management in Women with PCOS: What is the Evidence? Int J Exerc Sci. 2021 Aug 1;14(3):840-854. eCollection 2021.
Results Reference
background
PubMed Identifier
31319405
Citation
Kogure GS, Miranda-Furtado CL, Pedroso DCC, Ribeiro VB, Eiras MC, Silva RC, Caetano LC, Ferriani RA, Calado RT, Dos Reis RM. Effects of Progressive Resistance Training on Obesity Indices in Polycystic Ovary Syndrome and the Relationship With Telomere Length. J Phys Act Health. 2019 Aug 1;16(8):601-607. doi: 10.1123/jpah.2018-0256.
Results Reference
background
Citation
Mitrašinović-Brulić M, Buljan M, Suljević D. Association of LH/FSH ratio with menstrual cycle regularity and clinical features of patients with polycystic ovary syndrome. Middle East Fertility Society Journal. 2021;26(1):40.
Results Reference
background

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High Intensity Resistance and Aerobic Training Among Women With PCOS

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