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Completed

NCT Number: NCT07819331

Adding Receptive Music to Intradialytic Resistance Exercise in Adults Receiving Maintenance Hemodialysis

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.

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Key information

Conditions

End-stage Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Mtar d'Hemodialyse

Mahdia, Mahdia Governorate, 5180, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intradialytic Resistance Exercise

Behavioral

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.

Receptive Music Listening

Behavioral

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.

Primary outcomes

  1. 60-Second Sit-to-Stand Test Performance

    Time frame: Baseline and 8 weeks

    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.

Secondary outcomes

  1. Dialysis Adequacy (Single-Pool Kt/V)

    Time frame: Baseline and 8 weeks

    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.

  2. Systolic Blood Pressure

    Time frame: Baseline and 8 weeks

    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.

  3. Diastolic Blood Pressure

    Time frame: Baseline and 8 weeks

    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.

  4. Health-Related Quality of Life (SF-36)

    Time frame: Baseline and 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

The Higher Institute of Sport and Physical Education of Sfax

Other

Registry information

Official study title

Adding Receptive Music to Intradialytic Resistance Exercise: Effects on Physical Function in People Receiving Maintenance Haemodialysis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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