NCT05398575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
Last Updated

June 1, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

April 19, 2022

Last Update Submit

May 31, 2022

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Feeling scale

    Immediately before and after the intervention.

  • Evaluation of condition

    Immediately after the intervention

Study Arms (3)

Standard treatment with tailored music playlist

EXPERIMENTAL

Music playlist tailored for a group of 5-8 individuals.

Behavioral: Music

Standard treatment with radio music

ACTIVE COMPARATOR

Listening to local radio channel with music

Behavioral: Music

Standard treatment without music

NO INTERVENTION

Standard physiotherapy with no audio intervention

Interventions

MusicBEHAVIORAL

Participants listen to music during physiotherapy rehabilitation (tailored or radio music)

Standard treatment with radio musicStandard treatment with tailored music playlist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Denmark Region

Aalborg, Denmark

Location

MeSH Terms

Conditions

Stroke

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Daniel S Mazhari-Jensen, MA

    Aalborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2022

First Posted

June 1, 2022

Study Start

February 1, 2018

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

June 1, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)