EndometriosisNCT05834283
Aerobic vs Core Stability Exercise Training Program in Women With Endometriosis
A study testing aerobic exercises and core stability exercises in people with Endometriosis, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of aerobic and core stability exercise training program on pain, sleep and quality of life in women with endometriosis. Read more about this study
- Who is it for?
- Ages 24 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- aerobic exercises and core stability exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 15 Mar 2023
- 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 24 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 24-45
- Diagnosed patients with endometriosis
- Pain lasting more than 6 months
- Chronic pelvic pain
- Infertility
- Patients with dysmenorrhea.
Who cannot join
- Patients with the tubo- ovarian abscess.
- Concomitment use of hormonal drugs.
- Any malignancy
- Impaired sensation..
- Patients with Gynecological hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Aerobic and Core Stability Exercise Training Program on Pain, Sleep and Quality of Life in Women With Endometriosis.
To compare the effects of aerobic and core stability exercise training program on pain, sleep and quality of life in women with endometriosis.
- Conditions
- Endometriosis
- Being tested
- aerobic exercises, core stability exercises
- Keywords
- endometriosis, Aerobic exercises,, core stability,, 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 exercisesOther
This group will be received aerobic exercises 3 sessions per week for 8 weeks. Warm up phase: in which each participant will walk at 80 m/min at 0.0% grade for 5 mint.
Active phase: treadmill speed will be increased to 147 m/min and grade will be increased gradually untill reached 25% grade for 20 mint.
Cool down phase: in which the treadmil speed and grade will be decreased to 2.0miles/h and 0.0% grade during a cool down period consisted of 5 mint.
core stability exercisesOther
This group will be received core stability exercises 3 sessions per week for 8 weeks.
All participants in both groups will be evaluated before and after the treatment programs.
Lie on your back and place your feet on a wall so that your knees and hips are bent at 90 degrees angles. Tighten your abdominal muscles.
Raise your head and shoulders off the floor. Return to the start position and repeat.
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercises | Experimental | This group will be received aerobic exercises 3 sessions per week for 8 weeks. Warm up phase: in which each participant will walk at 80 m/min at 0.0% grade for 5 mint.
Active phase: treadmill speed will be increased to 147 m/min and grade will be increased gradually untill reached 25% grade for 20 mint.
Cool down phase: in which the treadmil speed and grade will be decreased to 2.0miles/h and 0.0% grade during a cool down period consisted of 5 mint. Receives: Other: aerobic exercises |
| core stability exercises | Experimental | This group will be received core stability exercises 3 sessions per week for 8 weeks.
All participants in both groups will be evaluated before and after the treatment programs.
Lie on your back and place your feet on a wall so that your knees and hips are bent at 90 degrees angles. Tighten your abdominal muscles.
Raise your head and shoulders off the floor. Return to the start position and repeat. Receives: Other: core stability exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale for pain
Numerical pain rating scale are the simplest and most commonly used scales. A tool used to help person rate the intensity of pain. The patients pick (verbal version) or draws a circle around (written version) the number that best describes the pain dimensions, usually intensity. The numeric pain rating scale for pain is a straight line with one end meaning no pain and the other end meaning worst pain
Measured: 8 weeks
Endometriosis health profile questionnaire (EHP 30) for quality of life.
Endometriosis health profile questionnaire (EHP 30) is to evaluate the suitably self- report health status. It involves 30 items to identify the health status of patients with endometriosis. A core questionnaire which consists of five scales (pain, control and powerlessness, emotional well-being support and self-image)
Measured: 8 weeks
Pittsburgh sleep quality index (PSQI) for sleep.
Pitts burgh sleep quality index (PSQI) is a self- rated questionnaire which asses the sleep quality and disturbance over a one-month time interval. It differentiates poor from good sleep quality. The PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations. Clinical studies have found the PSQI to be reliable and valid in assessment of sleep problems to some degree
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 posted28 Apr 2023
- Study start1 Jan 2023
- Primary completion8 Jan 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Neelam, PPDPT, Principal investigator, Riphah International University, Senior lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834283
- Sponsor's protocol ID
- REC/RCR&AHS/23/0522
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vigano P, Parazzini F, Somigliana E, Vercellini P. Endometriosis: epidemiology and aetiological factors. Best Pract Res Clin Obstet Gynaecol. 2004 Apr;18(2):177-200. doi: 10.1016/j.bpobgyn.2004.01.007.
PubMed 15157637Bourdel N, Alves J, Pickering G, Ramilo I, Roman H, Canis M. Systematic review of endometriosis pain assessment: how to choose a scale? Hum Reprod Update. 2015 Jan-Feb;21(1):136-52. doi: 10.1093/humupd/dmu046. Epub 2014 Sep 1.
PubMed 25180023Ferrero S, Alessandri F, Racca A, Leone Roberti Maggiore U. Treatment of pain associated with deep endometriosis: alternatives and evidence. Fertil Steril. 2015 Oct;104(4):771-792. doi: 10.1016/j.fertnstert.2015.08.031. Epub 2015 Sep 10.
PubMed 26363387Chauvet P, Auclair C, Mourgues C, Canis M, Gerbaud L, Bourdel N. Psychometric properties of the French version of the Endometriosis Health Profile-30, a health-related quality of life instrument. J Gynecol Obstet Hum Reprod. 2017 Mar;46(3):235-242. doi: 10.1016/j.jogoh.2017.02.004. Epub 2017 Feb 7.
PubMed 28403920Cheong Y, William Stones R. Chronic pelvic pain: aetiology and therapy. Best Pract Res Clin Obstet Gynaecol. 2006 Oct;20(5):695-711. doi: 10.1016/j.bpobgyn.2006.04.004. Epub 2006 Jun 9.
PubMed 16765092
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Aerobic and Core Stability Exercise Training Program on Pain, Sleep and Quality of Life in Women With Endometriosis.
- ClinicalTrials.gov ID
- NCT05834283
- Acronym / sponsor ID
- REC/RCR&AHS/23/0522
- Conditions
- Endometriosis
- Keywords
- endometriosis, Aerobic exercises,, core stability,, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 8 Jan 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 28 Apr 2023 (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.
To compare the effects of aerobic and core stability exercise training program on pain, sleep and quality of life in women with endometriosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic exercises | Experimental | Other: aerobic exercisesThis group will be received aerobic exercises 3 sessions per week for 8 weeks. Warm up phase: in which each participant will walk at 80 m/min at 0.0% grade for 5 mint. Active phase: treadmill speed will be increased to 147 m/min and grade will be increased gradually untill reached 25% grade for 20 mint. Cool down phase: in which the treadmil speed and grade will be decreased to 2.0miles/h and 0.0% grade during a cool down period consisted of 5 mint. |
| core stability exercises | Experimental | Other: core stability exercisesThis group will be received core stability exercises 3 sessions per week for 8 weeks. All participants in both groups will be evaluated before and after the treatment programs. Lie on your back and place your feet on a wall so that your knees and hips are bent at 90 degrees angles. Tighten your abdominal muscles. Raise your head and shoulders off the floor. Return to the start position and repeat. |
Who may qualify
- Ages
- 24 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 24-45
Key exclusion criteria (5 listed)
- Patients with the tubo- ovarian abscess.
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 exercisesThis group will be received aerobic exercises 3 sessions per week for 8 weeks. Warm up phase: in which each participant will walk at 80 m/min at 0.0% grade for 5 mint. Active phase: treadmill speed will be increased to 147 m/min and grade will be increased gradually untill reached 25% grade for 20 mint. Cool down phase: in which the treadmil speed and grade will be decreased to 2.0miles/h and 0.0% grade during a cool down period consisted of 5 mint. | Other | aerobic exercises |
| core stability exercisesThis group will be received core stability exercises 3 sessions per week for 8 weeks. All participants in both groups will be evaluated before and after the treatment programs. Lie on your back and place your feet on a wall so that your knees and hips are bent at 90 degrees angles. Tighten your abdominal muscles. Raise your head and shoulders off the floor. Return to the start position and repeat. | Other | core stability exercises |
Primary outcome
Numeric pain rating scale for pain
Time frame: 8 weeks
Numerical pain rating scale are the simplest and most commonly used scales. A tool used to help person rate the intensity of pain. The patients pick (verbal version) or draws a circle around (written version) the number that best describes the pain dimensions, usually intensity. The numeric pain rating scale for pain is a straight line with one end meaning no pain and the other end meaning worst pain
Endometriosis health profile questionnaire (EHP 30) for quality of life.
Time frame: 8 weeks
Endometriosis health profile questionnaire (EHP 30) is to evaluate the suitably self- report health status. It involves 30 items to identify the health status of patients with endometriosis. A core questionnaire which consists of five scales (pain, control and powerlessness, emotional well-being support and self-image)
Pittsburgh sleep quality index (PSQI) for sleep.
Time frame: 8 weeks
Pitts burgh sleep quality index (PSQI) is a self- rated questionnaire which asses the sleep quality and disturbance over a one-month time interval. It differentiates poor from good sleep quality. The PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations. Clinical studies have found the PSQI to be reliable and valid in assessment of sleep problems to some degree
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 28 Apr 2023.
- Background: PubMed 15157637Vigano P, Parazzini F, Somigliana E, Vercellini P. Endometriosis: epidemiology and aetiological factors. Best Pract Res Clin Obstet Gynaecol. 2004 Apr;18(2):177-200. doi: 10.1016/j.bpobgyn.2004.01.007.
- Background: PubMed 25180023Bourdel N, Alves J, Pickering G, Ramilo I, Roman H, Canis M. Systematic review of endometriosis pain assessment: how to choose a scale? Hum Reprod Update. 2015 Jan-Feb;21(1):136-52. doi: 10.1093/humupd/dmu046. Epub 2014 Sep 1.
- Background: PubMed 26363387Ferrero S, Alessandri F, Racca A, Leone Roberti Maggiore U. Treatment of pain associated with deep endometriosis: alternatives and evidence. Fertil Steril. 2015 Oct;104(4):771-792. doi: 10.1016/j.fertnstert.2015.08.031. Epub 2015 Sep 10.
- Background: PubMed 28403920Chauvet P, Auclair C, Mourgues C, Canis M, Gerbaud L, Bourdel N. Psychometric properties of the French version of the Endometriosis Health Profile-30, a health-related quality of life instrument. J Gynecol Obstet Hum Reprod. 2017 Mar;46(3):235-242. doi: 10.1016/j.jogoh.2017.02.004. Epub 2017 Feb 7.
- Background: PubMed 16765092Cheong Y, William Stones R. Chronic pelvic pain: aetiology and therapy. Best Pract Res Clin Obstet Gynaecol. 2006 Oct;20(5):695-711. doi: 10.1016/j.bpobgyn.2006.04.004. Epub 2006 Jun 9.
- Individual participant dataSharing planned: No
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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.
Hafiza Neelam, 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 and core stability exercises 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 6 inclusion and 5 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 28 Apr 2023. 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?
Numeric pain rating 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?
On the ClinicalTrials.gov record for NCT05834283, which also lists 5 linked publications.
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 28 Apr 2023.