Skip to main content
OpenTrials
Completed

NCT Number: NCT05348265

High Intensity Interval Training in PCOS

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Railway Hospital

Rawalpindi, Punjab Province, 43600, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Intensity steady state training

Other

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.

High Intensity Interval Training

Other

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 outcomes

  1. Mental Well-being

    Time frame: 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.

  2. Illness perception

    Time frame: 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.

  3. weight

    Time frame: 8th week

    Changes from the baseline the Weight will be measured using a digital weighing scale in kilograms.

  4. BMI

    Time frame: 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.

  5. waist-to-hip ratio

    Time frame: 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 outcomes

  1. Polycystic ovary syndrome health-related Quality of life questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of High Intensity Interval Training on Psychological Well Being, Anthropometrics, and Quality of Life in Females With Polycystic Ovarian Syndrome

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2022
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.