Adding Receptive Music to Intradialytic Resistance Exercise: Effects on Physical Function in People Receiving Maintenance Haemodialysis
| Registry | NCT07819331 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 47 (Actual) |
| Sponsor | The Higher Institute of Sport and Physical Education of Sfax (Other) |
| Conditions | End-Stage Kidney Disease |
| Interventions | Intradialytic Resistance Exercise, Receptive Music Listening (Behavioral) |
| Dates | start 2024-09-12, primary completion 2025-02-05, completion 2025-02-06, first posted 2026-09-14, last updated 2026-09-14 |
| Locations | 1 site in Tunisia |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Resistance Exercise Plus Receptive Music | Experimental | Behavioral: Intradialytic Resistance Exercise; Behavioral: Receptive Music Listening | 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. |
| Resistance Exercise Alone | Active comparator | Behavioral: Intradialytic Resistance Exercise | 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 |
| Usual Care | No intervention | 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 |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Age 18 years or older. * Receiving maintenance haemodialysis three times weekly for at least 3 months. * Able to perform lower-limb resistance exercise. * Clinically stable, defined as no hospitalisation for a cardiovascular event within the preceding 3 months. Exclusion Criteria: Unstable cardiovascular disease, including recent acute coronary syndrome, uncontrolled arrhythmias, or symptomatic heart failure. * Severe musculoskeletal or neurological conditions limiting exercise capacity. * Active infection. * Recurrent intradialytic hypotension, defined as two or more symptomatic episodes in the previous month. * Inability to understand and follow study instructions.
| Facility | City | Country | Status |
|---|---|---|---|
| Clinique Mtar d'Hemodialyse | Mahdia, Mahdia Governorate | Tunisia |