The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment - II (MAINTAIN-II)
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|ClinicalTrials.gov Identifier: NCT02946060|
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : April 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Physical Activity||Other: Audiobooks Other: Tempo-pace synchronized playlists Other: Usual Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||169 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment - II|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||August 2017|
Sham Comparator: Usual Care
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
iPods containing either a silent track or white noise
Active Comparator: Audiobooks
Participants in this arm will receive iPods with Audiobooks based on their preferred genres.
iPods with audiobooks
Experimental: Tempo-pace Synchronized Playlists
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
Playlists with or without RAS
- Average volume of physical activity per week per intervention [ Time Frame: 12 weeks ]The activity monitor will be worn each week for 12 weeks. Average minutes of physical activity per week will be compared between groups.
- Affect measured by Feeling Scale [ Time Frame: Biweekly for the duration of 12 weeks ]During participant's biweekly exercise session, scores on the Feeling Scale will be recorded per lap.
- Arousal measured by Score on Felt Arousal [ Time Frame: Biweekly for the duration of 12 weeks ]During participants biweekly exercise session, scores on the Felt Arousal Scale will be recorded per lap
- Perceived Exertion measured by Rate of Perceived Exertion Scale [ Time Frame: Biweekly for the duration of 12 weeks ]During participants biweekly exercise session, scores on the Rate of Perceived Exertion Scale (RPE) will be recorded per lap.
- Dissociative Attention measured by the Tammen's Scale [ Time Frame: Biweekly for the duration of 12 weeks ]During participants biweekly exercise session, scores on the Tammen's scale will be recorded per lap.
- Focus measured by the Focus Questionnaire [ Time Frame: Biweekly for the duration of 12 weeks ]During participants' biweekly exercise session, focus on the audio in the headphones will be recorded at the end of the exercise.
- Pacing of Exercise [ Time Frame: Biweekly for the duration of 12 weeks ]Number of steps in one minute will be counted during exercise session.
- Lap time [ Time Frame: Biweekly for the duration of 12 weeks ]Time taken to complete one lap will be recorded for each biweekly exercise session.
- Playcounts [ Time Frame: 8 week duration ]Number of plays of the audio file per week will be recorded
- Future Hospitalizations and/or Mortality [ Time Frame: Within 2 years ]Participants will be tracked longitudinally throughout health service encounters including physician visits, hospitalizations, and mortality.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946060
|Cardiac Rehabilitation and Prevention Program|
|Toronto, Ontario, Canada, M4G 2V6|
|Principal Investigator:||Dr. David Alter, MD,PhD,FRCPC||Toronto Rehabilitation Institute|