High Intensity Interval Training in PCOS

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Other: High intensity interval training; Other: Low Intensity steady state training

• Registration Number: NCT05348265
• Lead Sponsor: Riphah International University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-04-27
• Primary Completion: 2022-08-25
• Study Completion: 2022-08-25
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-24
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• females 18 to 45 years of age
• Diagnosed with PCOS based on Rotterdam criteria
• Ferriman and Gallway score of >8 for hirsutism

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High intensity interval training	High intensity interval training	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.
Low Intensity steady state training	Low Intensity steady state training	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.

Primary Outcome Measures

Name	Time	Method
Mental Well-being	8th Week	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.
weight	8th week	Changes from the baseline the Weight will be measured using a digital weighing scale in kilograms.
BMI	8th week	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.
Illness perception	8th Week	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.
waist-to-hip ratio	8th Week	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

Name	Time	Method
Polycystic ovary syndrome health-related Quality of life questionnaire	8th Week	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.

Trial Locations

Locations (1)

Pakistan Railway Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan