Effects of Traditional Moderate Intensity Training and High Intensity Interval Training in Polycystic Ovarian Syndrome

September 3, 2024 updated by: Riphah International University

Comparative Effects of Traditional Moderate Intensity Training and High Intensity Interval Training on Anxiety, Fatigue and Quality of Life in Polycystic Ovarian Syndrome

To determine the comparative effects of traditional moderate intensity training and high intensity interval training on Anxiety, fatigue and Quality of Life in females with polycystic ovarian syndrome

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

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 Locations

  • Pakistan
      • Lahore, Pakistan, 05499
        • Gynecological Department of Fatima Memorial 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

Yes

Description

Inclusion Criteria:

  • Participants with BMI greater than 25kg/m2
  • Oligo- or anovulation/irregular cycles i.e 35 days
  • Married women
  • Primary infertility
  • A diagnosis of polycystic ovaries based on ultrasound results

Exclusion Criteria:

  • Use of psychiatric or psychotropic medications.
  • Unresolved gynecological conditions i.e Cervical Dysplasia, Pelvic floor prolapse, Uterine Fibroids, Urinary Incontinence
  • Diabetes, pregnancy, smoking, illness or injury that prevented or limited exercise performance and existing participation in regular physical activity

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRADITIONAL MODERATE INTENSITY TRAINING
Other: RADITIONAL MODERATE INTENSITY TRAINING

It consists of patients who will receive High-intensity interval training, including running as well as walking at 80% to 95% HR peak. Which is monitored by a smart watch. Before starting treatment, it follows a 10-minute warm-up exercise which includes basic stretches (Quads, Hams, and calf muscles) with a 30-second hold of both legs and same exercise will be pursued for the cool-down period. This intervention will be performed 5 days per week for 4 weeks.

The total duration of this session will be 50 minutes
Active Comparator: HIGH INTENSITY INTERVAL TRAINING
Other: HIGH INTENSITY INTERVAL TRAINING

It consists of patients who will receive Moderate-intensity interval training, including running as well as walking at 60% HR peak. Which is monitored by a smart watch. Before starting treatment, it follows a 10-minute warm-up exercise which includes basic stretches (Quads, Hams, and calf muscles) with a 30-second hold of both legs and same exercise will be pursued for the cool-down period. This intervention will be performed 5 days per week for 4 weeks.

The total duration of this session will be 50 minutes (

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Anxiety Rating scale (HAM-A)
Time Frame: 4th week
The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Although the HAM-A remains widely used as an outcome measure in clinical trials. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Reliability and concurrent validity of the HAM-A and its subscales were sufficient. The Cronbach's α of the Hamilton Anxiety Scale was 0.89
4th week
The Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ)
Time Frame: 4th week
The PCOSQ consists of five domains, each relating to a common symptom of PCOS; body hair, emotions, infertility, menstrual problems and infertility. Each question on the PCOSQ is associated with a 7-point scale in which 7 represents optimal function and 1 the poorest function. All five PCOSQ dimensions were internally reliable with Cronbach's alpha scores ranging from 0.70 to 0.97. Intra-class correlation coefficients to evaluate test-retest reliability were high (range 0.89-0.95, P < 0.001). All five PCOSQ dimensions were internally reliable with Cronbach's α scores ranging from 0.70 to 0.97. Construct validity was demonstrated by high correlations for PCOSQ (0.49 and 0.54)
4th week
The Fatigue Impact Scale (FIS)
Time Frame: 4th week
The FIS was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Daily Fatigue Impact Scale (D-FIS) consist of eight items that could be used for monitoring daily changes in fatigue. The test-retest reliability of FIS was good in terms of its cognitive, physical, and psychosocial subscales and total scores, with ICC values of 0.78, 0.73, 0.80, and 0.83, respectively
4th week

Collaborators and Investigators

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

Sponsor

Riphah International University

Investigators

  • Principal Investigator: hina gul, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 23, 2023

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 19, 2024

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

September 3, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/23/0577

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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