End-Stage Kidney DiseaseNCT07819331
Adding Receptive Music to Intradialytic Resistance Exercise in Adults Receiving Maintenance Hemodialysis
A study testing Intradialytic Resistance Exercise and Receptive Music Listening in people with End-Stage Kidney Disease, run by The Higher Institute of Sport and Physical Education of Sfax at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Kidney Disease
- What is being tested?
- Intradialytic Resistance Exercise and Receptive Music Listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteTunisia
- Study dates
- 12 Sep 2024to 6 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adding Receptive Music to Intradialytic Resistance Exercise: Effects on Physical Function in People Receiving Maintenance Haemodialysis
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.
Read the detailed description
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.
- Conditions
- End-Stage Kidney Disease
- Being tested
- Intradialytic Resistance Exercise, Receptive Music Listening
- Keywords
- Maintenance Hemodialysis, Intradialytic Exercise, Resistance Exercise, Receptive Music, Physical Function, 60-Second Sit-to-Stand Test
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradialytic Resistance ExerciseBehavioural
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 ListeningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start12 Sep 2024
- Primary completion5 Feb 2025
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-Stage Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Higher Institute of Sport and Physical Education of Sfax
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kais Elabed, The Higher Institute of Sport and Physical Education of Sfax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819331
- Sponsor's protocol ID
- ISSEPS-IREM-2024
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no participant-level data-sharing plan was established for this study.
Publications
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.
PubMed 36013455
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Receptive Music to Intradialytic Resistance Exercise: Effects on Physical Function in People Receiving Maintenance Haemodialysis
- ClinicalTrials.gov ID
- NCT07819331
- Acronym / sponsor ID
- ISSEPS-IREM-2024
- Conditions
- End-Stage Kidney Disease
- Keywords
- Maintenance Hemodialysis, Intradialytic Exercise, Resistance Exercise, Receptive Music, Physical Function, 60-Second Sit-to-Stand Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- The Higher Institute of Sport and Physical Education of SfaxUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise Plus Receptive Music | Experimental | Behavioral: Intradialytic Resistance Exercise, Behavioral: Receptive Music ListeningParticipants 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 ExerciseParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradialytic Resistance ExerciseParticipants 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. | Behavioural | Resistance Exercise Alone, Resistance Exercise Plus Receptive Music |
| Receptive Music ListeningParticipants 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. | Behavioural | Resistance Exercise Plus Receptive Music |
Primary outcome
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.
4 secondary outcomes
Dialysis Adequacy (Single-Pool Kt/V)
Time frame: Baseline and 8 weeks
Systolic Blood Pressure
Time frame: Baseline and 8 weeks
Diastolic Blood Pressure
Time frame: Baseline and 8 weeks
Health-Related Quality of Life (SF-36)
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 36013455Mitsiou 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no participant-level data-sharing plan was established for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradialytic Resistance Exercise and Receptive Music Listening in people with End-Stage Kidney Disease, run by The Higher Institute of Sport and Physical Education of Sfax at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
60-Second Sit-to-Stand Test Performance (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07819331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.