Intradialytic Aerobic Exercise in CKD Patient

March 19, 2025 updated by: Irma Ruslina Defi, Universitas Padjadjaran
Intradialytic aerobic exercise is not effective in increasing hemodialysis adequacy but is effective in improving physical performance in twice-weekly hemodialysis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Uremic myopathy occurs in 60-75% of Chronic Kidney Disease (CKD) patients undergoing hemodialysis, which causes a decrease in muscle strength and physical performance. Increasing dialysis adequacy is beneficial in reducing the impact of uremia on muscles. Intradialytic aerobic exercise in thrice-weekly hemodialysis patients has improved dialysis adequacy and physical performance. This study aims to determine the effect of intradialytic aerobic exercise on improving dialysis adequacy and physical performance in twice-weekly hemodialysis patients.

Study Type

Interventional

Enrollment (Actual)

34

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 Locations

  • Indonesia
    • West Java
      • Bandung, West Java, Indonesia
        • Al Ihsan 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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • End Stage Renal Disease Patient stage 5 with Glomerular Filtration Rate <15mL/minute/1.73m2 aged 25-54 years undergoing hemodialysis two times per week for three months to five years
  • Hemoglobin levels > 8mg/dl
  • Mini-Mental State Examination (MMSE) score of ≥24
  • Hamilton Depression Rating Scale (HDRS) score <25

Exclusion Criteria:

  • Received aerobic exercise in the last 3 months
  • History of hospitalization in the last 3 months
  • Access for hemodialysis circulation via the femoral vein.
  • IMT <18,5 (underweight) dan ≥35 (obese class II)
  • Non-stable cardiovascular disease, uncontrolled glucose, acute infection disease

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional Group
subjects in the treatment group underwent routine hemodialysis by committing to an intradialysis aerobic exercise program
Behavioral: Aerobic Exercise
Intradialytic aerobic exercise for eight weeks
No Intervention: Control Group
subjects in the control group underwent routine hemodialysis without a physical exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kt/V
Time Frame: eight weeks
Dialysis adequacy (Kt/V) and physical performance test with a Short Physical Performance Battery (SPPB) were evaluated before and after the intervention
eight weeks

Collaborators and Investigators

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

Sponsor

Universitas Padjadjaran

Investigators

  • Principal Investigator: Irma Ruslina Defi, Universitas Padjadjaran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2023

Primary Completion (Actual)

December 27, 2023

Study Completion (Actual)

December 27, 2023

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IKFR.10.23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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