Clinical trial NCT01752595: The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment
Official title: The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Compliance Behavior
Patient Compliance
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: Ontario Centres of Excellence
name: University of Toronto
First posted: 2012-12-19
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Auditory motor-coupling has been shown to induce neural-entrainment that can synchronize walking-pace with sonic tempo. The extent to which acoustical-motor entrainment can induce longer-term changes to physical activity behaviours remains unclear.

Cardiac rehabilitation is essential and is associated with irrefutable mortality benefits for patients following an acute cardiac event. Randomized clinical trials have demonstrated a 25-50% improvement in survival as compared to controls; however, as many as 50% of patients will dropout of such programs prior to completion, which undermines these morbidity and mortality benefits (37; 54). Research exploring ways to improve compliance to such programs has suggested that the incorporation of music and other such holistic, patient-centered interventions into a rehabilitation/exercise program is associated with improved motivation, endurance and satisfaction amongst cardiac rehabilitation participants. The MAINTAIN study has been designed to conduct a feasibility evaluation on the effects of a preference-based music intervention on adherence to the cardiac rehabilitation program at Toronto Rehabilitation Institute. The primary objective of the trial is to evaluate the feasibility of the implementation of such a protocol within the context of the program.

This is a two-arm, block 2:1 randomized trial. 35 patients participating in cardiac rehabilitation at Toronto Rehabilitation: Cardiac Rehabilitation and Secondary Prevention Program will be recruited and participants will be randomized into: 1) control (standard, usual care); and, 2) music intervention. The randomization process employed will be a blocked 2:1 strategy, whereby subjects are randomized to the music treatment arms 2:1. All those patients randomized into arm 2 will be equally randomized into either (2) preference-based music intervention, (3) preference-based music enhanced with RAS. The primary outcome measure will be weekly physical activity over a 3 month duration as measured using tri-axial accelerometers. We will also analyze the impact of a preference-based music intervention based on audio playlist utilization, self-reported sitting times ,exercise-times, on-site attendance to the cardiac rehabilitation program (attendance), peak oxygen uptake (VO2) (stress-test), and self-efficacy levels (self-efficacy questionnaires). These measures will be collected and analyzed throughout the course of the intervention (3 months).


Eligibility criteria: Inclusion Criteria:

* English-speaking patients, who are participating in and have been declared medically stable for out-patient cardiac rehabilitation, will be recruited from the Toronto Rehabilitation Institute's Cardiac Rehabilitation and Secondary Prevention Program.

Exclusion Criteria:

* Participants who are unable to wear the MP3 device or the activity monitoring device due to medical or non-medical issues will be excluded from this study.
* Subjects that have a medical history of seizure disorders, previous neurosurgery, or known head trauma will be excluded from this study.
* Subjects that have received a bicycle-based exercise prescription.

Primary outcomes:
measure: Duration of physical activity
timeFrame: 3 months
Secondary outcomes:
measure: On-site program attendance
timeFrame: 3 months
measure: Change in Cardio Pulmonary Assessment Score
timeFrame: Baseline, 3 months
measure: Changes in Stafford Self-Efficacy Questionnaire/Cardiac Self-Efficacy Questionnaire Scores
timeFrame: Baseline, 3 months
measure: Audio-play list use
timeFrame: 3 months
measure: Study recruitment and drop-out
timeFrame: 3 months
Other outcomes:
measure: Interview and Focus Group
timeFrame: 3 months
Locations:
city: Toronto
country: Canada
facility: Toronto Cardiac Rehabilitation Institute
state: Ontario
Study officials:
affiliation: Toronto Rehabilitation Institute
name: Dr. David Alter
role: PRINCIPAL_INVESTIGATOR
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