Effect of Core Exercise on ADL in Hemodialysis

May 1, 2025 updated by: Mohammed Youssef Elhamrawy, Beni-Suef University

Effect of Core Stability Exercise Training on Activities of Daily Living, Fatigue Level and Balance in Hemodialysis

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mohammed S Saif, Ph.D

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Kz hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study Group
30 hemodialysis patient
Other: core Stability exercise
core stability exercise training
Other: Breathing exercises
Deep breathing and diaphragmatic breathing exercises
Active Comparator: Control group
30 hemodialysis patient
Other: Breathing exercises
Deep breathing and diaphragmatic breathing exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activities of Daily Livings (ADLs)
Time Frame: up to 8 weeks
ADLs will be assessed by Barthel Index (BI)
up to 8 weeks
Fatigue
Time Frame: up to 8 weeks
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
Balance
Time Frame: up to 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Principal Investigator: Mohammed S Saif, National institute for Gerontology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2024

Primary Completion (Estimated)

August 15, 2025

Study Completion (Estimated)

November 15, 2025

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

May 1, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • core exercise

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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