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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05834283
Other study ID # REC/RCR&AHS/23/0522
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date March 15, 2023

Study information

Verified date April 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 15, 2023
Est. primary completion date January 8, 2023
Accepts healthy volunteers No
Gender Female
Age group 24 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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.
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.

Locations

Country Name City State
Pakistan Family Health Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 8 weeks
Primary 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) 8 weeks
Primary 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 8 weeks
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