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

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

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

Conditions
-----------------
Physical Activity

Intervention / Treatment
-----------------
* Other: Audiobooks
* Other: Tempo-pace synchronized playlists
* Other: Usual Care


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

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Usual Care<br>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. | Other: Usual Care<br>* iPods containing either a silent track or white noise<br>|
| Active Comparator: Audiobooks<br>Participants in this arm will receive iPods with Audiobooks based on their preferred genres. | Other: Audiobooks<br>* iPods with audiobooks<br>|
| Experimental: Tempo-pace Synchronized Playlists<br>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. | Other: Tempo-pace synchronized playlists<br>* Playlists with or without RAS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average volume of physical activity per week per intervention | The activity monitor will be worn each week for 12 weeks. Average minutes of physical activity per week will be compared between groups. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Affect measured by Feeling Scale | During participant's biweekly exercise session, scores on the Feeling Scale will be recorded per lap. | Biweekly for the duration of 12 weeks | 
| Arousal measured by Score on Felt Arousal | During participants biweekly exercise session, scores on the Felt Arousal Scale will be recorded per lap | Biweekly for the duration of 12 weeks | 
| Perceived Exertion measured by Rate of Perceived Exertion Scale | During participants biweekly exercise session, scores on the Rate of Perceived Exertion Scale (RPE) will be recorded per lap. | Biweekly for the duration of 12 weeks | 
| Dissociative Attention measured by the Tammen's Scale | During participants biweekly exercise session, scores on the Tammen's scale will be recorded per lap. | Biweekly for the duration of 12 weeks | 
| Focus measured by the Focus Questionnaire | During participants' biweekly exercise session, focus on the audio in the headphones will be recorded at the end of the exercise. | Biweekly for the duration of 12 weeks | 
| Pacing of Exercise | Number of steps in one minute will be counted during exercise session. | Biweekly for the duration of 12 weeks | 
| Lap time | Time taken to complete one lap will be recorded for each biweekly exercise session. | Biweekly for the duration of 12 weeks | 
| Playcounts | Number of plays of the audio file per week will be recorded | 8 week duration | 
| Future Hospitalizations and/or Mortality | Participants will be tracked longitudinally throughout health service encounters including physician visits, hospitalizations, and mortality. | Within 2 years |