Effects of Aerobic Exercise and Core Muscle Strengthening on Pain, Menstrual Pattern and QOL in Endometriosis

April 18, 2024 updated by: Riphah International University

Effects of Aerobic Exercise With and Without Core Muscle Strengthening on Pain, Menstrual Pattern and Quality of Life in Endometriosis

Endometriosis is a complex and debilitating gynecological condition affecting millions of women worldwide. It is characterized by the abnormal growth of endometrial-like tissue outside the uterus, leading to chronic pelvic pain, dysmenorrhea, dyspareunia, and reduced quality of life. While pharmacological interventions are commonly prescribed to manage symptoms, their efficacy may be limited, and they often come with adverse effects. Therefore, exploring non-pharmacological approaches, such as exercise, is crucial in improving the management of endometriosis-related symptoms. Aerobic exercise has gained attention as a potential therapeutic intervention for endometriosis due to its positive effects on pain modulation, hormonal regulation, and overall well-being.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial (RCT) will be conducted at Jinnah Hospital in Lahore, Pakistan, to investigate the effects of aerobic exercise with and without core muscle strengthening on pain, menstrual pattern, and quality of life in women diagnosed with endometriosis. The study will employ a convenient randomization sampling technique, aiming to recruit approximately 30 participants who meet the inclusion criteria. Eligible participants will be reproductive-age women experiencing endometriosis-related pain, with regular menstrual cycles or irregularities associated with endometriosis. They should be medically stable, cleared for physical activity, and willing to participate in an exercise intervention program. Exclusion criteria include pregnancy, severe endometriosis-related complications, significant comorbidities, recent surgery, ongoing hormonal treatments targeting endometriosis, inability to participate in exercise programs, and severe mental health conditions. By investigating these interventions, the study seeks to improve symptom management, menstrual regularity, and overall quality of life for women with endometriosis while considering safety and feasibility within the study setting.

Keywords: Endometriosis, Menstrual pattern, Aerobic Exercise, Core Muscle Strengthening, Quality of Life

Study Type

Interventional

Enrollment (Actual)

30

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
    • 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:

  • Women diagnosed with endometriosis.(16)
  • Age range (e.g., 18-49 years)
  • Regular menstrual cycles or menstrual irregularities associated with endometriosis.
  • Medically stable and cleared for participation in physical activity.
  • No contraindications for aerobic exercise or core muscle strengthening

Exclusion Criteria:

  • Pregnant individuals or those actively trying to conceive.
  • Recent endometriosis-related surgeries/procedures
  • Use of hormonal therapies/medications targeting endometriosis
  • Severe endometriosis complications requiring immediate medical intervention
  • Inability to engage in aerobic exercise.
  • Significant cardiovascular/respiratory conditions
  • Concurrent participation in another exercise/rehabilitation program

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
Experimental: Aerobic Exercise Group with Core Muscle strengthening Group
Participants assigned to this group will undergo a combination of aerobic exercise and core muscle strengthening interventions. The aerobic exercise component will be similar to the first group, while additional exercises targeting the core muscles (abdomen, back, and pelvis) will be included.
Other: Aerobic Exercises with core Muscle strengthening
Participants assigned to this group will undergo a combination of aerobic exercise and core muscle strengthening interventions. The aerobic exercise component will be similar to the first group, while additional exercises targeting the core muscles (abdomen, back, and pelvis) will be included.
Active Comparator: Aerobic Exercise without Core Muscle Strengthening Group
Participants assigned to this group will engage in aerobic exercise interventions
Other: Aerobic Exercise without Core Muscle Strengthening
Aerobic Exercise without Core Muscle Strengthening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale for Pain:
Time Frame: 8 weeks
The Visual Analog Scale (VAS) for Pain is a commonly used instrument for assessing pain intensity. It is a subjective measure that asks individuals to rate their pain on a continuous line or scale. The VAS typically consists of a 10 cm line with anchor points representing "no pain" on one end and "worst possible pain" on the other end. Participants are instructed to mark the line at the point that represents their current level of pain.
8 weeks
Endometrial Health Profile-30 Endometrial Health Profile
Time Frame: 8 weeks
The EHP-30 (Endometrial Health Profile-30) is a specific questionnaire designed to assess the impact of endometriosis on various aspects of a person's life. It is a self-report instrument that measures health-related quality of life in individuals with endometriosis.
8 weeks
Menstrual pattern Bleeding score MIQ questionnaire
Time Frame: 8 weeks
The Menstrual Pattern Bleeding Score MIQ (Menstrual Impact Questionnaire) questionnaire is a specific tool used to assess the impact of menstrual patterns and bleeding on individuals' lives. It is a self-report questionnaire that measures the severity and impact of menstrual symptoms and irregularities on various aspects of daily functioning.
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

January 28, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 5, 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

  • S22C14G92019

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.

Clinical Trials on Endometriosis

Clinical Trials on Aerobic Exercises with core Muscle strengthening

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe