Back to resultsHigh Intensity Interval Training in PCOS
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Low Intensity steady state training
High intensity interval training
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
Inclusion Criteria:
- females 18 to 45 years of age
- Diagnosed with PCOS based on Rotterdam criteria
- Ferriman and Gallway score of >8 for hirsutism
Exclusion Criteria:
- Use of hormonal contraceptives or IUDs for contraception
- Taking metformin <3 months prior to the inclusion
- Breast feeding mothers
- Type I or II DM
- Hypo/hyperthyroidism
- Regular high-intensity endurance or strength training (defined as ≥ 2 sessions of vigorous exercise per week), Physical ailments/injuries that limited exercise performance.
Sites / Locations
- Pakistan Railway Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Low Intensity steady state training
High intensity interval training
Arm Description
Intervention will be provided for a period of 8 weeks. For the first 4 weeks the intervention will consist of 35-40 minutes of supervised slow paced treadmill walk, five days a week. From week 5 till 8 the intervention will consist of 50-60 minutes of supervised slow paced treadmill walk, five days a week.
Intervention will be provided for a period of 8 weeks, thrice a week. Intervention will start with a 5 minutes warm up period of jogging in place. For the first 4 weeks, 3 series of these exercises will be performed with 3 minutes of rest in between: 30 seconds burpees + 30 seconds recovery, 30 seconds lunges + 30 seconds recovery, 30 seconds skipping + 30 seconds recovery, 30 seconds squats + 30 seconds recovery. Exercise session will be followed by a cool down of 5 to 10 minutes with upper and lower extremity stretches. Intervention will start with a 5 minutes warm up period of jogging in place. For weeks 5 to 8, 4 series of these exercises will be performed with 3 minutes of rest in between: 30 seconds burpees + 30 seconds recovery, 30 seconds lunges + 30 seconds recovery, 30 seconds skipping + 30 seconds recovery, 30 seconds squats + 30 seconds recovery. Exercise session will be followed by a cool down of 5 to 10 minutes with upper and lower extremity stretches.
Outcomes
Primary Outcome Measures
Mental Well-being
Changes from the baseline Warwick Edinburgh Mental Well-being Scale is a 14 item scale of mental well-being covering subjective well-being and psychological functioning, in which all items are worded positively and address aspects of positive mental health. The scale is scored by summing responses to each item answered on a1 to5 scale. The minimum scale score is 14 and the maximum is 70.
Illness perception
Changes from the baseline The Brief Illness Perception Questionnaire (IPQ) it consists of 9 items rated on a scale of 0 to 10. First five items asses such as effect on life (item 1); duration of illness (item 2); control over illness (item 3); beliefs about the effectiveness of treatment (item 4); and experience of symptoms (item 5). Items 6 and 8 assess emotional aspects to include concern about illness and a multifaceted question about mood. Item 7 assesses degree of understanding of the illness. The final item is open-ended, asking respondents to rank the three most important factors causing their illness. . A higher score reflects a more threatening view of the illness.
weight
Changes from the baseline the Weight will be measured using a digital weighing scale in kilograms.
BMI
Changes from the baseline the BMI will be measured by dividing weight in kilograms by height in centimeters. BMI Asian will be used for categorization i.e. less than 18.5 kg/m2 is underweight, 18.5 to 23 18.5 kg/m2 is normal, 23 to 27.5 18.5 kg/m2 is overweight and more than 27 18.5 kg/m2 is obese.
waist-to-hip ratio
changes from the baseline waist to hip ratio will be measured using a measuring tape. A score of less than 0.8 is considered normal, 0.81 to 0.85 is moderate and more than 0.86 is higher.
Secondary Outcome Measures
Polycystic ovary syndrome health-related Quality of life questionnaire
Changes from the baseline The PCOSQ contains the following domains: emotions (8 items), hirsutism (5 items), weight (5 items), infertility (4 items), and menstrual disorders (4 items). Each item can be answered by choosing from a Likert scale with 7 options from 1 (always) to 7 (never). Higher scores are indicative of better function.
Full Information
NCT ID
NCT05348265
First Posted
April 21, 2022
Last Updated
November 24, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05348265
Brief Title
High Intensity Interval Training in PCOS
Official Title
Effects of High Intensity Interval Training on Psychological Well Being, Anthropometrics, and Quality of Life in Females With Polycystic Ovarian Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
August 25, 2022 (Actual)
Study Completion Date
August 25, 2022 (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
Yes
5. Study Description
Brief Summary
Study objective is to determine the effect of High intensity interval training on psychological wellbeing, Anthropometrics and Quality of life in females with Polycystic Ovarian Syndrome
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
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Intensity steady state training
Arm Type
Active Comparator
Arm Description
Intervention will be provided for a period of 8 weeks. For the first 4 weeks the intervention will consist of 35-40 minutes of supervised slow paced treadmill walk, five days a week. From week 5 till 8 the intervention will consist of 50-60 minutes of supervised slow paced treadmill walk, five days a week.
Arm Title
High intensity interval training
Arm Type
Experimental
Arm Description
Intervention will be provided for a period of 8 weeks, thrice a week. Intervention will start with a 5 minutes warm up period of jogging in place. For the first 4 weeks, 3 series of these exercises will be performed with 3 minutes of rest in between: 30 seconds burpees + 30 seconds recovery, 30 seconds lunges + 30 seconds recovery, 30 seconds skipping + 30 seconds recovery, 30 seconds squats + 30 seconds recovery.
Exercise session will be followed by a cool down of 5 to 10 minutes with upper and lower extremity stretches.
Intervention will start with a 5 minutes warm up period of jogging in place. For weeks 5 to 8, 4 series of these exercises will be performed with 3 minutes of rest in between: 30 seconds burpees + 30 seconds recovery, 30 seconds lunges + 30 seconds recovery, 30 seconds skipping + 30 seconds recovery, 30 seconds squats + 30 seconds recovery.
Exercise session will be followed by a cool down of 5 to 10 minutes with upper and lower extremity stretches.
Intervention Type
Other
Intervention Name(s)
Low Intensity steady state training
Intervention Description
Intervention will be provided for a period of 8 weeks. For the first 4 weeks the intervention will consist of 35-40 minutes of supervised slow paced treadmill walk, five days a week. From week 5 till 8 the intervention will consist of 50-60 minutes of supervised slow paced treadmill walk, five days a week.
Intervention Type
Other
Intervention Name(s)
High intensity interval training
Intervention Description
Intervention will be provided for a period of 8 weeks, thrice a week. Intervention will start with a 5 minutes warm up period of jogging in place. For the first 4 weeks, 3 series of these exercises will be performed with 3 minutes of rest in between: 30 seconds burpees + 30 seconds recovery, 30 seconds lunges + 30 seconds recovery, 30 seconds skipping + 30 seconds recovery, 30 seconds squats + 30 seconds recovery.
Exercise session will be followed by a cool down of 5 to 10 minutes with upper and lower extremity stretches.
Intervention will start with a 5 minutes warm up period of jogging in place. For weeks 5 to 8, 4 series of these exercises will be performed with 3 minutes of rest in between: 30 seconds burpees + 30 seconds recovery, 30 seconds lunges + 30 seconds recovery, 30 seconds skipping + 30 seconds recovery, 30 seconds squats + 30 seconds recovery.
Exercise session will be followed by a cool down of 5 to 10 minutes with upper and lower extremity stretches.
Primary Outcome Measure Information:
Title
Mental Well-being
Description
Changes from the baseline Warwick Edinburgh Mental Well-being Scale is a 14 item scale of mental well-being covering subjective well-being and psychological functioning, in which all items are worded positively and address aspects of positive mental health. The scale is scored by summing responses to each item answered on a1 to5 scale. The minimum scale score is 14 and the maximum is 70.
Time Frame
8th Week
Title
Illness perception
Description
Changes from the baseline The Brief Illness Perception Questionnaire (IPQ) it consists of 9 items rated on a scale of 0 to 10. First five items asses such as effect on life (item 1); duration of illness (item 2); control over illness (item 3); beliefs about the effectiveness of treatment (item 4); and experience of symptoms (item 5). Items 6 and 8 assess emotional aspects to include concern about illness and a multifaceted question about mood. Item 7 assesses degree of understanding of the illness. The final item is open-ended, asking respondents to rank the three most important factors causing their illness. . A higher score reflects a more threatening view of the illness.
Time Frame
8th Week
Title
weight
Description
Changes from the baseline the Weight will be measured using a digital weighing scale in kilograms.
Time Frame
8th week
Title
BMI
Description
Changes from the baseline the BMI will be measured by dividing weight in kilograms by height in centimeters. BMI Asian will be used for categorization i.e. less than 18.5 kg/m2 is underweight, 18.5 to 23 18.5 kg/m2 is normal, 23 to 27.5 18.5 kg/m2 is overweight and more than 27 18.5 kg/m2 is obese.
Time Frame
8th week
Title
waist-to-hip ratio
Description
changes from the baseline waist to hip ratio will be measured using a measuring tape. A score of less than 0.8 is considered normal, 0.81 to 0.85 is moderate and more than 0.86 is higher.
Time Frame
8th Week
Secondary Outcome Measure Information:
Title
Polycystic ovary syndrome health-related Quality of life questionnaire
Description
Changes from the baseline The PCOSQ contains the following domains: emotions (8 items), hirsutism (5 items), weight (5 items), infertility (4 items), and menstrual disorders (4 items). Each item can be answered by choosing from a Likert scale with 7 options from 1 (always) to 7 (never). Higher scores are indicative of better function.
Time Frame
8th Week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
females 18 to 45 years of age
Diagnosed with PCOS based on Rotterdam criteria
Ferriman and Gallway score of >8 for hirsutism
Exclusion Criteria:
Use of hormonal contraceptives or IUDs for contraception
Taking metformin <3 months prior to the inclusion
Breast feeding mothers
Type I or II DM
Hypo/hyperthyroidism
Regular high-intensity endurance or strength training (defined as ≥ 2 sessions of vigorous exercise per week), Physical ailments/injuries that limited exercise performance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Ehsan, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Railway Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
43600
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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High Intensity Interval Training in PCOS
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