The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment - II

The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment - II

Sponsors

Lead sponsor: Toronto Rehabilitation Institute

Collaborator: Heart and Stroke Foundation of Canada

Source Toronto Rehabilitation Institute
Brief Summary

This study (MAINTAIN -II) aims to examine the effect of audio playlists [with or without Rhythmic Auditory Stimulation (RAS)] on the weekly volume of physical activity. Participants will be randomized into 3 Interventions: Control (standard, usual care), Audiobook, or Tempo-pace Synchronized Playlists (TSP). The investigators also aim to explore the effects of these interventions on mood, perceived exertion and dissociative attention among patients participating in cardiac rehabilitation.

Detailed Description

Physical activity is associated with a 35% decrease in cardiovascular mortality - a direct result of exercise on the vasculature and an indirect result of exercise lowering CVD risk factors such as lipids and blood pressure. With physical inactivity being one of the major independent risk factors for CVD, structured exercise cardiac rehabilitation programs have been implemented to encourage adherence to physical activity among patients with cardiac related issues. Clinical trial evidence has demonstrated irrefutable mortality and morbidity benefits associated with cardiac rehabilitation especially among patients with established CVD. The mechanisms for improved outcomes are likely multifactorial, including improved preventative self-management, physical activity volume, and cardiopulmonary fitness. Unfortunately the real-world outcome benefits associated with cardiac rehabilitation are undermined by behavioural attrition, with programmatic drop out and suboptimal physical activity adherence patterns that mirror the broader healthy population who are not enrolled in cardiac rehabilitation.

Unfortunately the real-world outcome benefits associated with cardiac rehabilitation are undermined by attrition rates of up to 50% post rehabilitation. The goal would therefore be to introduce a co-intervention that encourages long-term exercise adherence for maximal health improvements in cardiac rehabilitation populations, which might also have broader applicability to other non-cardiac rehab populations.

The prior study, The Music Activity INTervention for Adherence Improvement through Neurological entrainment (MAINTAIN -1), examined the use of Tempo Synchronized Playlists (TSP) on improving exercise adherence within the cardiac rehabilitation program. Weekly volumes of physical activity were compared between groups assigned to 3 interventions: control group receiving Usual Care, TSP, and Tempo-pace Synchronized Playlists with Rhythmic Auditory Stimulation (RAS). Rhythmic Auditory Stimulation is a neurological rehabilitation technique used to accentuate tempo-pace synchrony. The group assigned to the TSP intervention demonstrated a significantly higher volume in weekly exercise than the usual care control group. Furthermore, the group randomized to TSP with RAS partook in twice the amount of weekly physical activity than the TSP group without RAS. Our prior study had several limitations including small sample size and an inability to examine the mechanisms by which RAS tempo-based audio-playlist synchronization mediated increases in physical activity.

The objective of this current study is to build on our previous research by examining the reproducibility of efficacy and exploring the mechanisms such as mood, perceived exertion and dissociative attention, by which the preference-based tempo-pace synchronized playlists improve exercise adherence among patients participating in cardiac rehabilitation. Participants will be randomized into 3 Interventions: Usual Care, Audiobooks, and TSP, that will be assigned during months 2 and 3 of the program. The Usual Care group will feature a nested design by which half patients will randomized to receive a silent track during month 2, and the other half will receive white noise. This sequence will be reversed during month 3. Within the TSP intervention, 2 nested designs will be tested. The first will test RAS with non-RAS. Half of the patients will be randomized to receive TSP with RAS during month 2 of the study, while the other half will receive TSP without RAS during month 2. The sequence will be reversed in month 3. The second will determine the effect on training by comparing 'active' vs. 'passive'. Within the active group, participants will be trained on how to exercise with the music. The passive group will not be trained.

Cardiac Rehabilitation provides an ideal test-case program by which to examine music co-interventions, as it mirrors the behavioural attrition experienced in other structured or unstructured exercise activities. Additionally, a music tempo-pace synchronization strategy is appropriate in such a setting as it helps to regulate the exercise pace prescribed to each patient by the program.

Overall Status Completed
Start Date February 2016
Completion Date August 2017
Primary Completion Date February 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Average volume of physical activity per week per intervention 12 weeks
Secondary Outcome
Measure Time Frame
Affect measured by Feeling Scale Biweekly for the duration of 12 weeks
Arousal measured by Score on Felt Arousal Biweekly for the duration of 12 weeks
Perceived Exertion measured by Rate of Perceived Exertion Scale Biweekly for the duration of 12 weeks
Dissociative Attention measured by the Tammen's Scale Biweekly for the duration of 12 weeks
Focus measured by the Focus Questionnaire Biweekly for the duration of 12 weeks
Pacing of Exercise Biweekly for the duration of 12 weeks
Lap time Biweekly for the duration of 12 weeks
Playcounts 8 week duration
Future Hospitalizations and/or Mortality Within 2 years
Enrollment 169
Condition
Intervention

Intervention type: Other

Intervention name: Audiobooks

Description: iPods with audiobooks

Arm group label: Audiobooks

Intervention type: Other

Intervention name: Tempo-pace synchronized playlists

Description: Playlists with or without RAS

Arm group label: Tempo-pace Synchronized Playlists

Intervention type: Other

Intervention name: Usual Care

Description: iPods containing either a silent track or white noise

Arm group label: Usual Care

Eligibility

Criteria:

Inclusion Criteria:

- Patients with known cardiovascular disease who are participating in and have been declared medically stable for outpatient cardiac rehabilitation

- Patients must be at least 18 years of age

- Patients must have received at least one exercise prescription that includes consistent walking and/or running (no high interval training or stationary machines)

Exclusion Criteria:

- Participants unable to wear the iPod device or activity monitoring device due to medical or non-medical issues

- Participants with significant communication impairments

- Participants currently enrolled in another intervention study

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Dr. David Alter, MD,PhD,FRCPC Principal Investigator Toronto Rehabilitation Institute
Location
facility
Cardiac Rehabilitation and Prevention Program
Location Countries

Canada

Verification Date

April 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Toronto Rehabilitation Institute

Investigator full name: Dr. David Alter

Investigator title: Principal Investigator

Has Expanded Access No
Number Of Arms 3
Arm Group

Arm group label: Usual Care

Arm group type: Sham Comparator

Description: Participants in this intervention will receive the minimal standard of care provided at the Cardiac Rehabilitation and Prevention Program at Toronto Rehabilitation Institute. Participants will receive an iPod with a silent track or white noise.

Arm group label: Audiobooks

Arm group type: Active Comparator

Description: Participants in this arm will receive iPods with Audiobooks based on their preferred genres.

Arm group label: Tempo-pace Synchronized Playlists

Arm group type: Experimental

Description: Participants in this arm will receive audio playlists synchronized to their exercise pace. Rhythmic enhancements will be added to the playlists during either month 2 or month 3 of the study.

Acronym MAINTAIN-II
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov