Effects of High-Intensity Interval Training and Strength Training On Levels of Testosterone and Physical Activity Among Women With Polycystic Ovary Syndrome.
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
High intensity interval training
Strength training
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring High intensity interval training, Exercise, Polycystic Ovary Syndrome, Physical Therapy, Strength training, Testosterone, Physical activity
Eligibility Criteria
Inclusion Criteria:
BMI:
- Overweight: 23-24.9 kg/m2.
- Obese: greater than or equal to 25 kg/m2 .
- Diagnosed and referred PCO patients to the rehabilitation unit would be selected for the study.
- Aged 18-40.
- High serum testosterone level: normal range 6-86 ng/dl.
Exclusion Criteria:
- On-going pregnancy.
- Any cardiovascular complication.
- Any other endocrine disorder
- Any musculoskeletal condition that hinders in performing the exercise training protocol.
Sites / Locations
- Shamim clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HIIT Group
ST Group
Arm Description
High intensity interval training will be performed thrice a week using a treadmill.
Strength training will be performed thrice a week, each session will consist of eight dynamic drills (with resistance of 60 - 70 % of 1 repetition maximum).
Outcomes
Primary Outcome Measures
Serum testosterone
Levels of serum testosterone
Secondary Outcome Measures
Body fat composition
Using skinfold method (body caliper)
Physical activity
International physical activity questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04942366
Brief Title
Effects of High-Intensity Interval Training and Strength Training On Levels of Testosterone and Physical Activity Among Women With Polycystic Ovary Syndrome.
Official Title
Effects of High-Intensity Interval Training and Strength Training On Levels of Testosterone and Physical Activity Among Women With Polycystic Ovary Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
September 26, 2021 (Actual)
Study Completion Date
September 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziauddin 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 RCT is aimed towards determining the effectiveness of exercises based intervention strategy involving high intensity interval training exercises in improving serum testosterone level, body fat composition and physical activity in hopes to provide a definitive exercise regime for the ever common symptoms of pcos. It will be based on the theory that exercise helps in decreasing testosterone level that in turn decrease high androgen levels in the body, exercise further decreases body fat composition (obesity is a common cause or manifestation of pcos).
Detailed Description
High intensity interval training will be performed over the course of 12 weeks and will be compared with the group performing strength training. Baseline assessments will be done before the start of the first session and post-test assessment will be done after the last session of the study.
Envelope method is used for the purpose of randomization. 50 envelopes having a title of group A and group B will be made and divided into two (25 in each group). Mutually exclusive technique will be used and the envelope once picked will not be replaced within the groups.
Sample size is calculated by using a previous study conducted in 2015 titled as, 'Effects of High Intensity Interval Training and Strength Training on Metabolic, Cardiovascular and Hormonal Outcomes in Women with Poly cystic Ovary Syndrome: A Pilot Study' by taking a confidence interval CI of 95%, power of test 80%, standard deviation of 6.3 and mean difference of 5.2, a sample size of 50 is calculated.
For the analysis of the data MedCalc software version 19.0.5. will be used. Descriptive statistics will be performed for the purpose of demographic information and this data will be presented in terms of frequency and percentage. Skewness and Kurtosis will be used in order to determine the normality of data. If the data is normally distributed, then for within the group analysis dependent T test will be performed. However, in case the data is not normally distributed Wilcoxon Sign Rank test will be performed. Independent T test will be performed for the comparison between the two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
High intensity interval training, Exercise, Polycystic Ovary Syndrome, Physical Therapy, Strength training, Testosterone, Physical activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups in which participants are randomly allocated while both groups will perform warm up and cool down session, Group A will perform High intensity interval training and Group B will perform strength training exercises.
Masking
ParticipantCare Provider
Masking Description
While the exercise protocol will be explained to the participant and care giver however the they will be blinded regarding which is intervention group or control group and which exercise is the main interventional exercise will not be disclosed.
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HIIT Group
Arm Type
Experimental
Arm Description
High intensity interval training will be performed thrice a week using a treadmill.
Arm Title
ST Group
Arm Type
Active Comparator
Arm Description
Strength training will be performed thrice a week, each session will consist of eight dynamic drills (with resistance of 60 - 70 % of 1 repetition maximum).
Intervention Type
Other
Intervention Name(s)
High intensity interval training
Other Intervention Name(s)
HIIT
Intervention Description
HIIT using treadmill four sets of 4 minute interval session (at 90%-95% of the individual HR max calculated by using the karvonen method) and each set will be followed by three minute of moderate intensity exercise (at 70% of individual HR max).
Intervention Type
Other
Intervention Name(s)
Strength training
Intervention Description
Strength training will be performed thrice a week, each session will consist of eight dynamic drills.
Primary Outcome Measure Information:
Title
Serum testosterone
Description
Levels of serum testosterone
Time Frame
0-12 weeks
Secondary Outcome Measure Information:
Title
Body fat composition
Description
Using skinfold method (body caliper)
Time Frame
0-12 weeks
Title
Physical activity
Description
International physical activity questionnaire
Time Frame
0-12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI:
Overweight: 23-24.9 kg/m2.
Obese: greater than or equal to 25 kg/m2 .
Diagnosed and referred PCO patients to the rehabilitation unit would be selected for the study.
Aged 18-40.
High serum testosterone level: normal range 6-86 ng/dl.
Exclusion Criteria:
On-going pregnancy.
Any cardiovascular complication.
Any other endocrine disorder
Any musculoskeletal condition that hinders in performing the exercise training protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mubarra Rao
Organizational Affiliation
Ziauddin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amna Amir Khan
Organizational Affiliation
Ziauddin University
Official's Role
Study Director
Facility Information:
Facility Name
Shamim clinic
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75340
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of High-Intensity Interval Training and Strength Training On Levels of Testosterone and Physical Activity Among Women With Polycystic Ovary Syndrome.
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