Music Listening for Cardiorespiratory Exercise in Inpatient Stroke Rehabilitation

Study Overview
=================
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.

Official Title
-----------------
Music Listening for Cardiorespiratory Exercise in Inpatient Stroke Rehabilitation

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: Music


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard treatment with tailored music playlist<br>Music playlist tailored for a group of 5-8 individuals. | Behavioral: Music<br>* Participants listen to music during physiotherapy rehabilitation (tailored or radio music)<br>|
| Active Comparator: Standard treatment with radio music<br>Listening to local radio channel with music | Behavioral: Music<br>* Participants listen to music during physiotherapy rehabilitation (tailored or radio music)<br>|
| No Intervention: Standard treatment without music<br>Standard physiotherapy with no audio intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate reserve | Time spent in therapeutic heart rate zone | Proportion of time during the 30 minutes session | 
| Exercise time | Time spent actively participating in the physiotherapy session | Proportion of time during the 30 minutes session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeling scale | 11 point Likert scale rating affective valence (current feeling state) | Immediately before and after the intervention. | 
| Evaluation of condition | Rating of preferred audio condition on a 10 point Likert scale | Immediately after the intervention |