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

NCT07819331 | Completed

• 1 other identifier: ISSEPS-IREM-2024
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End-Stage Kidney Disease

Keywords

Maintenance Hemodialysis; Intradialytic Exercise; Resistance Exercise; Receptive Music; Physical Function; 60-Second Sit-to-Stand Test

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 8 weeks

Secondary Outcomes (4)

• Dialysis Adequacy (Single-Pool Kt/V)

  Baseline and 8 weeks

• Systolic Blood Pressure

  Baseline and 8 weeks

• Diastolic Blood Pressure

  Baseline and 8 weeks

• Health-Related Quality of Life (SF-36)

  Baseline and 8 weeks

Study Arms (3)

Resistance Exercise Plus Receptive Music

EXPERIMENTAL

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

Resistance Exercise Alone

ACTIVE COMPARATOR

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

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

Interventions

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.

Resistance Exercise Alone; Resistance Exercise Plus Receptive Music

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.

Resistance Exercise Plus Receptive Music

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Higher Institute of Sport and Physical Education of Sfax: lead

Study Sites (1)

Clinique Mtar d'Hemodialyse

Mahdia, Mahdia Governorate, 5180, Tunisia

Location

Related Publications (1)

• Mitsiou M, Dimitros E, Roumeliotis S, Liakopoulos V, Kouidi E, Deligiannis A. Effects of a Combined Intradialytic Exercise Training Program and Music on Cardiac Autonomic Nervous System Activity in Hemodialysis Patients. Life (Basel). 2022 Aug 20;12(8):1276. doi: 10.3390/life12081276.

  PMID: 36013455 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three-arm, parallel-group randomized controlled trial with participants allocated in a 1:1:1 ratio to intradialytic resistance exercise combined with receptive music listening, intradialytic resistance exercise alone, or usual care.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: September 12, 2024
• Primary Completion: February 5, 2025
• Study Completion: February 6, 2025
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)