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

N/ANot Yet RecruitingNCT07758244

Muş Alparslan University40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hemodialysis Patients

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.