- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05834283
Aerobic vs Core Stability Exercise Training Program in Women With Endometriosis
Comparative Effects of Aerobic and Core Stability Exercise Training Program on Pain, Sleep and Quality of Life in Women With Endometriosis.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 540000
- Family Health Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age 24-45
- Diagnosed patients with endometriosis
- Pain lasting more than 6 months
- Chronic pelvic pain
- Infertility
- Patients with dysmenorrhea.
Exclusion Criteria:
Patients with the tubo- ovarian abscess.
- Concomitment use of hormonal drugs.
- Any malignancy
- Impaired sensation..
- Patients with Gynecological hemorrhage
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: aerobic exercises
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. |
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. |
|
Experimental: core stability exercises
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
8 weeks
|
|
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)
|
8 weeks
|
|
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
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hafiza Neelam, PPDPT, Riphah International University, Senior Lecturer
Publications and helpful links
General Publications
- Bourdel 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.
- Ferrero 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.
- 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.
- Chauvet 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.
- Cheong 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0522
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
Fabio BarraCompletedEndometriosis | Endometriosis, Rectum | Endometriosis of Vagina | Endometriosis Rectovaginal Septum | Endometriosis Pelvic | Endometriosis of ColonItaly
-
BioGene Pharmaceutical Ltd.WithdrawnSafety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis (ELTA)Endometriosis | Endometriosis Ovary | Endometriosis, Rectum | Endometriosis ExternaSwitzerland
-
Ospedale Policlinico San MartinoCompletedEndometriosis | Bowel Endometriosis | Endometriosis, Rectum | Endometriosis ColonItaly
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...CompletedEndometriosis | Endometriosis-related Pain | Endometriosis Thoracic | Endometriosis of Lung | Endometriosis of PleuraItaly
-
Ospedale Policlinico San MartinoCompletedEndometriosis, Rectum | Endometriosis, SigmoidItaly
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaUnknownBowel Endometriosis | Endometriosis, RectumItaly
-
Ospedale Policlinico San MartinoActive, not recruitingEndometriosis, Rectum | Endometriosis of ColonItaly
-
Catholic University of the Sacred HeartCompletedPelvic Endometriosis | Endometriosis Outside PelvisItaly
-
Semmelweis UniversityUniversity of PecsNot yet recruitingEndometriosis | Endometriosis Ovary | Endometriosis Rectovaginal Septum
-
Catholic University of the Sacred HeartCompletedPelvic Endometriosis | Endometriosis Outside PelvisItaly
Clinical Trials on aerobic exercises
-
University of Sao Paulo General HospitalCompleted
-
Cairo UniversityActive, not recruiting
-
Çankırı Karatekin UniversityHacettepe UniversityCompleted
-
University of HailCompleted
-
Istanbul Medipol University HospitalCompletedCognitive Function 1, SocialTurkey
-
Prince Sattam Bin Abdulaziz UniversityCompletedHealth, SubjectiveSaudi Arabia
-
Riphah International UniversityCompletedDepression | Sleep Quality | Primigravida FemalesPakistan
-
Ankara City Hospital BilkentRecruitingAxial Spondyloarthritis and Ankylosing SpondylitisTurkey
-
Istanbul UniversityCompletedFibromyalgia | Fibromyalgia Syndrome | Fibromyalgia (FM)Turkey (Türkiye)
-
Instituto Politécnico de Castelo BrancoCompleted