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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06241040
• Other study ID #: S22C14G92019
• Status: Completed
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: April 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Endometriosis

Intervention

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.
• Aerobic Exercise without Core Muscle Strengthening
Aerobic Exercise without Core Muscle Strengthening

Locations

Country	Name	City	State
Pakistan	Jinnah Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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