NCT05834283

Brief Summary

To compare the effects of aerobic and core stability exercise training program on pain, sleep and quality of life in women with endometriosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

7 days

First QC Date

April 18, 2023

Last Update Submit

April 18, 2023

Conditions

Endometriosis

Keywords

endometriosisAerobic exercises,core stability,Quality of life

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

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.

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.

Other: core stability exercises

Interventions

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.

aerobic exercises
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.

core stability exercises

Eligibility Criteria

Age24 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEndometriosis is condition that occurs only in females
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 24-45
  • Diagnosed patients with endometriosis
  • Pain lasting more than 6 months
  • Chronic pelvic pain
  • Infertility
  • Patients with dysmenorrhea.

You may not qualify if:

  • Patients with the tubo- ovarian abscess.
  • Concomitment use of hormonal drugs.
  • Any malignancy
  • Impaired sensation..
  • Patients with Gynecological hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Health Hospital

Lahore, Punjab Province, 540000, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 15157637BACKGROUND

  • 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.

    PMID: 25180023BACKGROUND

  • 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.

    PMID: 26363387BACKGROUND

  • 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.

    PMID: 28403920BACKGROUND

  • 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.

    PMID: 16765092BACKGROUND

MeSH Terms

Conditions

Endometriosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hafiza Neelam, PPDPT

    Riphah International University, Senior lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

April 28, 2023

Study Start

January 1, 2023

Primary Completion

January 8, 2023

Study Completion

March 15, 2023

Last Updated

April 28, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)