Back to resultsAerobic vs Core Stability Exercise Training Program in Women With Endometriosis
Primary Purpose
Endometriosis
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
aerobic exercises
core stability exercises
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring endometriosis, Aerobic exercises,, core stability,, Quality of life
Eligibility Criteria
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
Sites / Locations
- Family Health Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
aerobic exercises
core stability exercises
Arm Description
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 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.
Outcomes
Primary Outcome Measures
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
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)
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05834283
First Posted
April 18, 2023
Last Updated
April 18, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05834283
Brief Title
Aerobic vs Core Stability Exercise Training Program in Women With Endometriosis
Official Title
Comparative Effects of Aerobic and Core Stability Exercise Training Program on Pain, Sleep and Quality of Life in Women With Endometriosis.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 8, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
endometriosis, Aerobic exercises,, core stability,, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aerobic exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
core stability exercises
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
aerobic exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
core stability exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric pain rating scale for pain
Description
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
Time Frame
8 weeks
Title
Endometriosis health profile questionnaire (EHP 30) for quality of life.
Description
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)
Time Frame
8 weeks
Title
Pittsburgh sleep quality index (PSQI) for sleep.
Description
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
Time Frame
8 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Endometriosis is condition that occurs only in females
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafiza Neelam, PPDPT
Organizational Affiliation
Riphah International University, Senior lecturer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Family Health Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
540000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15157637
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.
Results Reference
background
PubMed Identifier
25180023
Citation
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.
Results Reference
background
PubMed Identifier
26363387
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.
Results Reference
background
PubMed Identifier
28403920
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.
Results Reference
background
PubMed Identifier
16765092
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.
Results Reference
background
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Aerobic vs Core Stability Exercise Training Program in Women With Endometriosis
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