An interventional study of Intradialytic Resistance Exercise and Receptive Music Listening in End-Stage Kidney Disease, sponsored by The Higher Institute of Sport and Physical Education of Sfax. Completed at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by The Higher Institute of Sport and Physical Education of Sfax · Not applicable, Interventional, and Treatment
People receiving maintenance hemodialysis commonly experience reduced physical function and exercise capacity. Intradialytic resistance exercise may help preserve or improve physical function, while receptive music listening may provide additional benefits when combined with exercise.
This randomized controlled trial evaluated whether adding receptive music listening to a supervised intradialytic resistance exercise program improved physical function compared with the same exercise program without music and with usual care. Forty-seven adults receiving maintenance hemodialysis were allocated to one of three groups: resistance exercise combined with receptive music listening, resistance exercise alone, or usual care. The intervention lasted 8 weeks and included 24 planned exercise sessions for participants assigned to the exercise groups.
The primary outcome was lower-limb functional performance assessed using the 60-second sit-to-stand test. Secondary outcomes included dialysis adequacy, blood pressure, health-related quality of life, intervention adherence, and adverse events.
This was a single-center, three-arm, parallel-group randomized controlled trial conducted in adults receiving maintenance hemodialysis. Participants were randomly allocated in a 1:1:1 ratio to intradialytic resistance exercise combined with receptive music listening, intradialytic resistance exercise alone, or usual hemodialysis care.
Participants assigned to either exercise group completed a supervised 8-week intradialytic resistance exercise program comprising 24 planned sessions. Exercise was initiated approximately 60 minutes after the start of the hemodialysis session and consisted of lower-limb resistance exercises targeting major muscle groups. Exercise intensity was guided using the Borg CR10 rating of perceived exertion scale, with a target intensity of 4 to 6. The receptive music group listened to individually selected music during the exercise sessions, whereas the exercise-only group performed the same exercise program without the study music intervention. Participants assigned to the control group continued usual hemodialysis care without the study exercise or music intervention.
Assessments were performed at baseline and after the 8-week intervention period. The primary outcome was lower-limb functional performance assessed using the 60-second sit-to-stand test. Secondary outcomes included dialysis adequacy, blood pressure, health-related quality of life, adherence to the planned intervention, and adverse events.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 47 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
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Exclusion Criteria:
Unstable cardiovascular disease, including recent acute coronary syndrome, uncontrolled arrhythmias, or symptomatic heart failure.
Participants received supervised intradialytic lower-limb resistance exercise combined with receptive music listening for 8 weeks, with 24 planned sessions. Exercise began approximately 60 minutes after the start of the hemodialysis session. Exercise intensity was guided by the Borg CR10 rating of perceived exertion scale, targeting 4 to 6. During exercise, participants listened to individually selected music.
Behavioral: Intradialytic Resistance Exercise · Behavioral: Receptive Music Listening
Participants received the same supervised intradialytic lower-limb resistance exercise program as the combined intervention group for 8 weeks, with 24 planned sessions, but without the study music intervention. Exercise began approximately 60 minutes after the start of the hemodialysis session. Exercise intensity was guided by the Borg CR10 rating of perceived exertion scale, targeting 4 to 6
Behavioral: Intradialytic Resistance Exercise
Participants continued their usual maintenance hemodialysis care during the 8-week study period and did not receive the study resistance exercise or receptive music intervention
Participants performed supervised lower-limb resistance exercise three times per week for 8 weeks, for a total of 24 planned sessions. Exercise began approximately 60 minutes after the start of hemodialysis and included exercises targeting the major lower-limb muscle groups using elastic resistance bands and/or ankle weights. The programme progressed from one to three sets of 10-15 repetitions according to individual tolerance. Exercise intensity was guided by the Borg CR10 rating of perceived exertion scale, targeting 4-6. Active exercise time was approximately 20-25 minutes per session.
Participants assigned to the exercise-plus-music arm listened to individually selected receptive music during each intradialytic resistance exercise session. Music was selected according to individual preference and delivered throughout the exercise period. The selected music had a tempo of approximately 60-80 beats per minute, with sound intensity limited to a maximum of 50 dB. Receptive music listening was provided during the 24 planned exercise sessions over the 8-week intervention period.
60-Second Sit-to-Stand Test Performance
Lower-limb functional performance was assessed using the 60-second sit-to-stand test. The outcome was the total number of complete sit-to-stand repetitions performed during 60 seconds. Higher values indicate better functional performance.
Time frame: Baseline and 8 weeks
Dialysis Adequacy (Single-Pool Kt/V)
Dialysis adequacy was assessed using single-pool Kt/V calculated with the second-generation Daugirdas equation. The outcome was the mean of three prespecified dialysis-session measurements at each assessment period. Higher values indicate greater dialysis adequacy.
Time frame: Baseline and 8 weeks
Systolic Blood Pressure
Systolic blood pressure was measured in millimetres of mercury (mmHg) using the automated non-invasive blood pressure monitoring system used in the dialysis unit. Lower values indicate lower systolic blood pressure.
Time frame: Baseline and 8 weeks
Diastolic Blood Pressure
Diastolic blood pressure was measured in millimetres of mercury (mmHg) using the automated non-invasive blood pressure monitoring system used in the dialysis unit. Lower values indicate lower diastolic blood pressure.
Time frame: Baseline and 8 weeks
Health-Related Quality of Life (SF-36)
Health-related quality of life was assessed using the validated Arabic version of the 36-Item Short Form Health Survey (SF-36). Eight domains were evaluated: physical functioning, role limitations due to physical health, role limitations due to emotional problems, social functioning, bodily pain, vitality, mental health, and general health. Each domain was scored from 0 to 100, with higher scores indicating better health status.
Time frame: Baseline and 8 weeks
Plan to share: No — Individual participant data will not be shared because no participant-level data-sharing plan was established for this study.
Ran from Sep 2024 to primary completion in Feb 2025, 4 months.
Of 347 non-industry interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's 4 months is below that.
Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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The Higher Institute of Sport and Physical Education of Sfax