NCT06241040

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

January 28, 2024

Last Update Submit

April 18, 2024

Conditions

Keywords

EndometriosisMenstrual patternAerobic ExerciseCore Muscle StrengtheningQuality of Life

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale for Pain:

    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

    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

    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

Study Arms (2)

Aerobic Exercise Group with Core Muscle strengthening Group

EXPERIMENTAL

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

Aerobic Exercise without Core Muscle Strengthening Group

ACTIVE COMPARATOR

Participants assigned to this group will engage in aerobic exercise interventions

Other: Aerobic Exercise without Core Muscle Strengthening

Interventions

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.

Aerobic Exercise Group with Core Muscle strengthening Group

Aerobic Exercise without Core Muscle Strengthening

Aerobic Exercise without Core Muscle Strengthening Group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEndometriosis occur during Menstrual Cycle
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital

Lahore, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Faiza Taufiq, PPDPT

    Riphah International University, Senior Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2024

First Posted

February 5, 2024

Study Start

March 15, 2023

Primary Completion

March 15, 2024

Study Completion

March 15, 2024

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations