Aerobic Training With and Without Resistance Training in Polycystic Ovarian Syndrome

April 18, 2024 updated by: Riphah International University

Effects of Aerobic Training With and Without Resistance Training on Waist to Hip Ratio, Quality of Life and Menstrual Dysfunction in Polycystic Ovarian Syndrome.

Polycystic ovary syndrome (PCOS) characterized by a chronic disorder in ovulation along with hyperandrogenism has become one of the most common endocrine disorders in women of reproductive age with an estimated 5%-15% prevalence. It has the symptoms such as menstrual disorders, infertility, hyperandrogenism, obesity, hirsutism and acne. PCOS is linked to Psychological morbidities e.g. increased risk of stress, depression, low self-esteem, poor body image, and reduced health-related quality of life. Approximately 75% of people with PCOS have a fat accumulation in the central area of the body.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Randomized controlled trial will be conducted to determine the effects of Aerobic training with and without resistance training on the waist to hip ratio, QoL and menstrual dysfunction in polycystic ovarian syndrome. A sample size of 22 PCOS women's will be taken, Data will be collected from Jinnah Hospital Lahore by using PCOSQ and SF-36 questionnaire. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups of equal members. One group undergoing aerobic with resistance exercise training i.e., the experimental group and other with aerobic exercise i.e., control group. The interventions will be provided for 30 mints for 3 days per week for 2 months. All participants in both groups will be evaluated before and after the treatment programs.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 44000
        • Jinnah Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-40yrs
  • Waist to hip ratio >87(20)
  • Women who are diagnosed according to Rotterdam criteria e.g. oligo/anovulation, hyperandrogenism, and polycystic ovaries.(21)
  • Female who physically able to performs exercise

Exclusion Criteria:

  • Women who are smoking and using drugs for depression.
  • Married women
  • Women with other pathological conditions like diabetes and thyroid diseases.
  • Females who are not able to perform resistant exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Aerobic Exercise (Control Group)
Group A will receive Aerobic exercise plan. The treatment will be given with the frequency of 3 times per week for 8 weeks. Treatment sessions will be of 30 minutes with short resting intervals
Other: Aerobic Exercise

Treatment Protocol to Group A It consists of patients who will receive aerobic exercise sessions 3 times per week for 8 weeks. Every session will be of 30 minutes.

It will include warm up phase, active phase and cool down phase Warm-up phase:

In which each participant will walk at 80 m/min at for 5 min.

Active phase:

Brisk walking or treadmill:

In which each participant will perform brisk walking for 15 mints initially. After that gradually duration of brisk walking will increase.
Experimental: Aerobic exercise with resistance training (Experimental Group)
Group B will receive aerobic and resistance exercise plan. The frequency of treatment will be as same as that of aerobic exercise program i.e. 3 times a week for 8 weeks. Treatment sessions will be of 45 minutes with short resting intervals
Other: Aerobic Exercises with Resistance training

These groups will perform these exercises:

Aerobic exercise +resistance exercises Exercise

Session: 3 days per week Time of exercise session: 30-45 min

After following protocol of aerobic exercise as mentioned above the subjects will perform resistance exercises. These Exercises will perform:

  1. Leg press (dual leg press):

    Leg press targets the Glutes "Quadriceps or quads .but they also work your "Hamstrings".

  2. Crunches:

    Crunches Target the abdominal muscles specifically rectus abdominis and obliques.

  3. Squats:

Squats targets the adductor muscles of the hip, glutes and rectus abdominis muscle Leg Extension

Total Exercise plan for 12 weeks:

1-2 weeks: Repitations: 10-15 times

No of sets: 1 set Resistance: minimum 3-4 weeks:

Repitations: 10-15 times

No of sets: 2 set Resistance: moderate 5-6 weeks:

Repitations: 15-16 times

No of sets: 2 set Resistance: moderate 7-8 weeks:

Repitations: 15-16 times No of sets: 2 set

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF-36 Questionnaire
Time Frame: 8 weeks
QoL was assessed by the validated Portuguese version of the self-reported MOS SF-36, which consists of eight subscales: (1) Physical Role Function, (2) Physical Functioning, (3) Bodily Pain, (4) General Health Perception, (5) Vitality, (6) Social Role Functioning, (7) Emotional Role functioning, and (8) Mental Health. A substantial body of research supports the reliability of the SF-36 measurements.validity of SF-36 Questionnaire is 0.90 Subscale scores range from 0 to 100, with a lower score indicating lower QoL for that subscale.
8 weeks
Self-administered PCOSQ
Time Frame: 8 weeks
All the participants filled up the self-administered PCOSQ. PCOS Questionnaire has 26 items divided into 5 domains: emotions (8 items), body hair (5 items), weight (5 items), infertility (4 items), and menstrual problems (4 items). Each question is associated with a 7point scale in which 7 represents optimal function and 1 represents the poorest Function. PCOSQ dimensions were internally reliable with Cronbach's a scores ranging from 0.70 to 0.97.
8 weeks
Measuring Tape
Time Frame: 8 weeks

Waist circumference (WC) was measured with the participant in the standing position, with arms at the side of the body, feet together, and with a relaxed abdomen. For WC, a horizontal measurement was obtained on the narrower part of the dorsum (above the navel and below the xiphoid process.

Hip circumference (HC) was measured using the same positioning, as the region with the largest circumference of the buttocks. Waist-to-hip ratio (WHR) was measured by dividing the WC value by the HC value
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Faiza Taufiq, PPDPT, Riphah International University, Senior Lecturer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Actual)

March 15, 2024

Study Completion (Actual)

March 15, 2024

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

December 26, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S22C14G92023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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