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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMuş Alparslan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Having received hemodialysis treatment for 4 hours a day, 3 days a week, for at least 3 months.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise

    Other intervention

    The use of intradialytic aerobic exercise in hemodialysis patients.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: aerobic exerciseActive comparator 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Dialysis Patient-Perceived Exercise Benefits and Barriers Scale (DPEBBS)

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.

Time frame
Two months
2

The End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ)

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.

Time frame
Two months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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