Physical Activity Clinical Trial
Official title:
The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment - II
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.
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.
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