StrokeNCT05398575
Music Listening for Cardiorespiratory Exercise in Inpatient Stroke Rehabilitation
A study testing Music in people with Stroke, run by University of Aarhus at 1 site in Denmark.
Trial summary
Stroke survivors struggle to meet clinical recommendations for physical exercise duration and intensity. During the past two decades, music interventions have increasingly shown effectiveness in several motor tasks in stroke rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2018to 30 May 2018
- 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
- between 2-12 weeks post ischemic or hemorrhagic stroke
- assessed eligible to participate in cardiorespiratory exercise by the patient's primary physiotherapist and interdisciplinary team -≥18 years old
Who cannot join
- uncontrolled medical contraindications for physical activity
- severe hearing deficit or cochlear implants
- severe deficit of both auditory and visual communication not allowing for guiding the patient in the exercise task
Trial locations and contacts
1 site in 1 country.
About this study
Stroke survivors struggle to meet clinical recommendations for physical exercise duration and intensity. During the past two decades, music interventions have increasingly shown effectiveness in several motor tasks in stroke rehabilitation. Additionally, music has been found effective in increasing exercise performance in athletes and other clinical populations. Based on a meta-theoretical review paper by Clark, Baker \& Taylor (2016), it was hypothesized that the therapeutic effects of music in physical exercise is modulated by the preference and task-specificity of the music. We will test this hypothesis using a three-armed randomized cross-over design comprised of the following auditory conditions: 1) a group-tailored playlist 2) radio as active control and 3) a non-music control condition during cycle ergometry cardiorespiratory exercise sessions. Participants are inpatient stroke survivors undergoing rehabilitation between 2-12 weeks post infarct.
- Conditions
- Stroke
- Being tested
- Music
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
Participants listen to music during physiotherapy rehabilitation (tailored or radio music)
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment with tailored music playlist | Experimental | Music playlist tailored for a group of 5-8 individuals. Receives: Behavioral: Music |
| Standard treatment with radio music | Active comparator | Listening to local radio channel with music Receives: Behavioral: Music |
| Standard treatment without music | No intervention | Standard physiotherapy with no audio intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate reserve
Time spent in therapeutic heart rate zone
Measured: Proportion of time during the 30 minutes session
Exercise time
Time spent actively participating in the physiotherapy session
Measured: Proportion of time during the 30 minutes session
Secondary outcomes (2)
Feeling scale
11 point Likert scale rating affective valence (current feeling state)
Measured: Immediately before and after the intervention.
Evaluation of condition
Rating of preferred audio condition on a 10 point Likert scale
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Feb 2018
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University, Regionshospital Nordjylland
- Responsible party
- Sponsor
- Investigators
- Daniel S Mazhari-Jensen, MA, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398575
- Sponsor's protocol ID
- Music cardio stroke
- Status last verified
- Mar 2022
- First submitted
- 19 Apr 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Listening for Cardiorespiratory Exercise in Inpatient Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT05398575
- Acronym / sponsor ID
- Music cardio stroke
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aalborg University, Regionshospital Nordjylland
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 1 Jun 2022 (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.
Stroke survivors struggle to meet clinical recommendations for physical exercise duration and intensity. During the past two decades, music interventions have increasingly shown effectiveness in several motor tasks in stroke rehabilitation. Additionally, music has been found effective in increasing exercise performance in athletes and other clinical populations. Based on a meta-theoretical review paper by Clark, Baker \& Taylor (2016), it was hypothesized that the therapeutic effects of music in physical exercise is modulated by the preference and task-specificity of the music. We will test this hypothesis using a three-armed randomized cross-over design comprised of the following auditory conditions: 1) a group-tailored playlist 2) radio as active control and 3) a non-music control condition during cycle ergometry cardiorespiratory exercise sessions. Participants are inpatient stroke survivors undergoing rehabilitation between 2-12 weeks post infarct.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard treatment with tailored music playlist | Experimental | Behavioral: MusicMusic playlist tailored for a group of 5-8 individuals. |
| Standard treatment with radio music | Active comparator | Behavioral: MusicListening to local radio channel with music |
| Standard treatment without music | No intervention | –Standard physiotherapy with no audio intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- between 2-12 weeks post ischemic or hemorrhagic stroke
- assessed eligible to participate in cardiorespiratory exercise by the patient's primary physiotherapist and interdisciplinary team -≥18 years old
Key exclusion criteria (3 listed)
- uncontrolled medical contraindications for physical activity
- severe hearing deficit or cochlear implants
- severe deficit of both auditory and visual communication not allowing for guiding the patient in the exercise task
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 |
|---|---|---|
| MusicParticipants listen to music during physiotherapy rehabilitation (tailored or radio music) | Behavioural | Standard treatment with radio music, Standard treatment with tailored music playlist |
Primary outcome
Heart rate reserve
Time frame: Proportion of time during the 30 minutes session
Time spent in therapeutic heart rate zone
Exercise time
Time frame: Proportion of time during the 30 minutes session
Time spent actively participating in the physiotherapy session
2 secondary outcomes
Feeling scale
Time frame: Immediately before and after the intervention.
Evaluation of condition
Time frame: Immediately after the intervention
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 1 Jun 2022.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Daniel S Mazhari-Jensen, MA principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Stroke, run by University of Aarhus at 1 site in Denmark.
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 2 inclusion and 3 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 1 Jun 2022. 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 Denmark. 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?
Heart rate reserve (time frame: Proportion of time during the 30 minutes session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2022.