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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06445647
Other study ID # core exercise
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 15, 2024
Est. completion date November 15, 2025

Study information

Verified date June 2024
Source Beni-Suef University
Contact Mohammed Yo Elhamrawy, Ph.D
Phone +201282805567
Email dr_melhamrawy@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Finding the effect of core stability exercises with breathing exercises on Activities of daily living (ADLs), fatigue level and balance in maintenance hemodialysis patients.


Description:

Sixty patients will be randomly assigned into two equal groups, the experimental (EX) group and the control group (CON). The participants' age will be 50-65 years and undergo hemodialysis. The Ex-group will attend three sessions/week of core stability exercise training (CSE) combined with Deep Breathing (25:30-min) for 8 weeks, the CON will attend 3 sessions/week of Deep Breathing (15-min) for 8 weeks. All the patients received only routine hemodialysis department care.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date November 15, 2025
Est. primary completion date February 15, 2025
Accepts healthy volunteers No
Gender All
Age group 55 Years to 70 Years
Eligibility Inclusion Criteria: - Adults ranging from 55- 70 years old of both genders. - Diagnosed as maintenance hemodialysis for at least 6 months or more. - Free from mental illness, neuromuscular disorders, and serious lung problems and able to implement the interventional exercise. Exclusion Criteria: - Obesity (BMI = 30 kg/m2) - Orthopeadics or neurological problems that interferes with training. - History of pulmonary problems (COPD, pneumonia) - History of Myocardial infarction and/or cardiothoracic surgery - Unstable medical status - Dementia that interferes with the ability to follow instructions. - History Chronic Fatigue Syndrome (CFS).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
core Stability exercise
core stability exercise training
Breathing exercises
Deep breathing and diaphragmatic breathing exercises

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Beni-Suef University

Outcome

Type Measure Description Time frame Safety issue
Primary Activities of Daily Livings (ADLs) ADLs will be assessed by Barthel Index (BI) up to 8 weeks
Primary Fatigue Fatigue will be assessed by fatigue assessment scale. The total score ranges from 10 to 50. A total score < 22 indicates no fatigue, a score = 22 indicates fatigue. up to 8 weeks
Primary Balance Balance will be assessed by berg balance scale, the balance score ranges from 0 to 56, with lower scores indicating increased risk of balance loss and higher scores indicating improved functional mobility. Time up and go test (TUG)n Score < 10 seconds = normal < 20 seconds = good mobility; can walk outside alone; does not require a walking aid < 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid. up to 8 weeks
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