- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07758244
The Effects of Intradialytic Aerobic Exercise on Clinical Parameters, Coping With Illness, Perceived Benefits of Exercise and Barriers to Exercise in Haemodialysis Patients: A Randomised Controlled Trial
August 6, 2026 updated by: Muş Alparslan University
THE EFFECTS OF INTRADİALYTİC AEROBİC EXERCİSE ON CLİNİCAL PARAMETERS, COPİNG WİTH ILLNESS, PERCEİVED BENEFİTS OF EXERCİSE AND BARRİERS TO EXERCİSE İN HAEMODİALYSİS PATİENTS: A RANDOMİSED CONTROLLED TRİAL
This randomized controlled trial aims to investigate the effects of an 8-week intradialytic aerobic exercise program on clinical parameters, disease adaptation, and perceived exercise benefits and barriers in patients undergoing maintenance hemodialysis.
Eligible participants will be randomly assigned to either an intervention group receiving supervised aerobic exercise during hemodialysis sessions or a control group receiving routine hemodialysis care.
Aerobic exercise will be performed three times per week during hemodialysis for eight weeks.
Exercise intensity will be individually adjusted according to the participant's subjective fatigue level using the 20-point Borg Rating of Perceived Exertion (RPE) scale, targeting an intensity of 11-13 ("light to somewhat hard").
Outcomes will be assessed before and after the intervention using validated clinical measurements and patient-reported outcome measures.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
40
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
- Name: Cengiz TAŞKAYA
- Phone Number: 05364811882
- Email: c.taskaya@alparslan.edu.tr
Study Contact Backup
- Name: Abdulsamed KAYA
- Phone Number: 05364400551
- Email: a1@alparslan.edu.tr
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:
- Having received hemodialysis treatment for 4 hours a day, 3 days a week, for at least 3 months.
Exclusion Criteria:
- Having a history of myocardial infarction within the last 3 months
- Having angina pectoris or uncontrolled arrhythmia and uncontrolled hypertension
- Having communication or cognitive problems to the extent that one cannot complete the required tests
- Being pregnant or undergoing infertility treatment
- Having a psychiatric diagnosis
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
|
|
|
Active Comparator: aerobic exercise
|
The use of intradialytic aerobic exercise in hemodialysis patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dialysis Patient-Perceived Exercise Benefits and Barriers Scale (DPEBBS)
Time Frame: Two months
|
This is a 4-point Likert scale (1- Strongly Disagree, 4- Strongly Agree).
The scale consists of 24 items and two open-ended questions.
It comprises five sub-dimensions: "Daily Life (7 items)", "Exercise-related Undesirable Outcomes (7 items)", "Quality of Life (4 items)", "Exercise Effects (3 items)", and "Exercise Benefits (3 items)".
The daily life and exercise-related undesirable outcomes sub-dimensions represent the obstacles to exercise, while the quality of life, exercise effects, and exercise benefits sub-dimensions represent the benefits of exercise.
Items 3, 4, 6, 7, 10, 13, 16, 20, 22, and 23 comprise the benefits sub-dimension; items 1, 2, 5, 8, 9, 11, 12, 14, 15, 17-19, 21, and 24 comprise the obstacles sub-dimension.
The items in the DPEBBS scale that represent barrier factors are reverse-coded.
The scale is evaluated based on a total score (min=24, max=96).
Higher scores indicate a greater perception of exercise benefits and fewer exercise barriers.
|
Two months
|
|
The End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ)
Time Frame: Two months
|
The scale, designed to assess adherence to end-stage renal failure, consists of nine questions and four sub-dimensions encompassing adherence behaviors: "hemodialysis participation," "medication adherence," "fluid restriction adherence," and "diet adherence."
The total score obtainable from the scale ranges from 0 to 1200.
Higher scores indicate higher adherence to treatment.
|
Two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Cengiz TAŞKAYA, Muş Alparslan University
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 (Estimated)
August 24, 2026
Primary Completion (Estimated)
August 28, 2026
Study Completion (Estimated)
October 23, 2026
Study Registration Dates
First Submitted
August 6, 2026
First Submitted That Met QC Criteria
August 6, 2026
First Posted (Actual)
August 11, 2026
Study Record Updates
Last Update Posted (Actual)
August 11, 2026
Last Update Submitted That Met QC Criteria
August 6, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- intradialytic cycling 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
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