Clinical trial NCT02946060: The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment - II
Official title: The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment - II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2016-10-26
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Average volume of physical activity per week per intervention
timeFrame: 12 weeks
Secondary outcomes:
measure: Affect measured by Feeling Scale
timeFrame: Biweekly for the duration of 12 weeks
measure: Arousal measured by Score on Felt Arousal
timeFrame: Biweekly for the duration of 12 weeks
measure: Perceived Exertion measured by Rate of Perceived Exertion Scale
timeFrame: Biweekly for the duration of 12 weeks
measure: Dissociative Attention measured by the Tammen's Scale
timeFrame: Biweekly for the duration of 12 weeks
measure: Focus measured by the Focus Questionnaire
timeFrame: Biweekly for the duration of 12 weeks
measure: Pacing of Exercise
timeFrame: Biweekly for the duration of 12 weeks
measure: Lap time
timeFrame: Biweekly for the duration of 12 weeks
measure: Playcounts
timeFrame: 8 week duration
measure: Future Hospitalizations and/or Mortality
timeFrame: Within 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Cardiac Rehabilitation and Prevention Program
state: Ontario
Study officials:
affiliation: Toronto Rehabilitation Institute
name: Dr. David Alter, MD,PhD,FRCPC
role: PRINCIPAL_INVESTIGATOR
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