Music Listening for Cardiorespiratory Exercise in Inpatient Stroke Rehabilitation
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Music
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- North Denmark Region
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Standard treatment with tailored music playlist
Standard treatment with radio music
Standard treatment without music
Arm Description
Music playlist tailored for a group of 5-8 individuals.
Listening to local radio channel with music
Standard physiotherapy with no audio intervention
Outcomes
Primary Outcome Measures
Heart rate reserve
Time spent in therapeutic heart rate zone
Exercise time
Time spent actively participating in the physiotherapy session
Secondary Outcome Measures
Feeling scale
11 point Likert scale rating affective valence (current feeling state)
Evaluation of condition
Rating of preferred audio condition on a 10 point Likert scale
Full Information
NCT ID
NCT05398575
First Posted
April 19, 2022
Last Updated
May 31, 2022
Sponsor
University of Aarhus
Collaborators
Aalborg University, North Denmark Regional Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05398575
Brief Title
Music Listening for Cardiorespiratory Exercise in Inpatient Stroke Rehabilitation
Official Title
Music Listening for Cardiorespiratory Exercise in Inpatient Stroke Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aalborg University, North Denmark Regional Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard treatment with tailored music playlist
Arm Type
Experimental
Arm Description
Music playlist tailored for a group of 5-8 individuals.
Arm Title
Standard treatment with radio music
Arm Type
Active Comparator
Arm Description
Listening to local radio channel with music
Arm Title
Standard treatment without music
Arm Type
No Intervention
Arm Description
Standard physiotherapy with no audio intervention
Intervention Type
Behavioral
Intervention Name(s)
Music
Intervention Description
Participants listen to music during physiotherapy rehabilitation (tailored or radio music)
Primary Outcome Measure Information:
Title
Heart rate reserve
Description
Time spent in therapeutic heart rate zone
Time Frame
Proportion of time during the 30 minutes session
Title
Exercise time
Description
Time spent actively participating in the physiotherapy session
Time Frame
Proportion of time during the 30 minutes session
Secondary Outcome Measure Information:
Title
Feeling scale
Description
11 point Likert scale rating affective valence (current feeling state)
Time Frame
Immediately before and after the intervention.
Title
Evaluation of condition
Description
Rating of preferred audio condition on a 10 point Likert scale
Time Frame
Immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel S Mazhari-Jensen, MA
Organizational Affiliation
Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Denmark Region
City
Aalborg
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Music Listening for Cardiorespiratory Exercise in Inpatient Stroke Rehabilitation
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