EndometriosisNCT06241040
Effects of Aerobic Exercise and Core Muscle Strengthening on Pain, Menstrual Pattern and QOL in Endometriosis
A study testing Aerobic Exercises with core Muscle strengthening and Aerobic Exercise without Core Muscle Strengthening in people with Endometriosis, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Aerobic Exercises with core Muscle strengthening and Aerobic Exercise without Core Muscle Strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2023to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Endometriosis
- Being tested
- Aerobic Exercises with core Muscle strengthening, Aerobic Exercise without Core Muscle Strengthening
- Keywords
- Endometriosis, Menstrual pattern, Aerobic Exercise, Core Muscle Strengthening, Quality of Life
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercises with core Muscle strengtheningOther
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 StrengtheningOther
Aerobic Exercise without Core Muscle Strengthening
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Aerobic Exercise without Core Muscle Strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start15 Mar 2023
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faiza Taufiq, PPDPT, Principal investigator, Riphah International University, Senior Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241040
- Sponsor's protocol ID
- S22C14G92019
- Status last verified
- Apr 2024
- First submitted
- 28 Jan 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise With and Without Core Muscle Strengthening on Pain, Menstrual Pattern and Quality of Life in Endometriosis
- ClinicalTrials.gov ID
- NCT06241040
- Acronym / sponsor ID
- S22C14G92019
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Menstrual pattern, Aerobic Exercise, Core Muscle Strengthening, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Group with Core Muscle strengthening Group | Experimental | Other: Aerobic Exercises with core Muscle strengtheningParticipants 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 Group | Active comparator | Other: Aerobic Exercise without Core Muscle StrengtheningParticipants assigned to this group will engage in aerobic exercise interventions |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercises with core Muscle strengtheningParticipants 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 Exercise Group with Core Muscle strengthening Group |
| Aerobic Exercise without Core Muscle StrengtheningAerobic Exercise without Core Muscle Strengthening | Other | Aerobic Exercise without Core Muscle Strengthening Group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
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Endometriosis Transcriptomic Cell Atlas
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Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faiza Taufiq, PPDPT principal investigator
Riphah International University, Senior Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercises with core Muscle strengthening and Aerobic Exercise without Core Muscle Strengthening in people with Endometriosis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale for Pain: (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.