- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02946060
The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment - II (MAINTAIN-II)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4G 2V6
- Cardiac Rehabilitation and Prevention Program
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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iPods containing either a silent track or white noise
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Active Comparator: Audiobooks
Participants in this arm will receive iPods with Audiobooks based on their preferred genres.
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iPods with audiobooks
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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.
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Playlists with or without RAS
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average volume of physical activity per week per intervention
Time Frame: 12 weeks
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The activity monitor will be worn each week for 12 weeks.
Average minutes of physical activity per week will be compared between groups.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Affect measured by Feeling Scale
Time Frame: Biweekly for the duration of 12 weeks
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During participant's biweekly exercise session, scores on the Feeling Scale will be recorded per lap.
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Biweekly for the duration of 12 weeks
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Arousal measured by Score on Felt Arousal
Time Frame: Biweekly for the duration of 12 weeks
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During participants biweekly exercise session, scores on the Felt Arousal Scale will be recorded per lap
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Biweekly for the duration of 12 weeks
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Perceived Exertion measured by Rate of Perceived Exertion Scale
Time Frame: Biweekly for the duration of 12 weeks
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During participants biweekly exercise session, scores on the Rate of Perceived Exertion Scale (RPE) will be recorded per lap.
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Biweekly for the duration of 12 weeks
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Dissociative Attention measured by the Tammen's Scale
Time Frame: Biweekly for the duration of 12 weeks
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During participants biweekly exercise session, scores on the Tammen's scale will be recorded per lap.
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Biweekly for the duration of 12 weeks
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Focus measured by the Focus Questionnaire
Time Frame: Biweekly for the duration of 12 weeks
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During participants' biweekly exercise session, focus on the audio in the headphones will be recorded at the end of the exercise.
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Biweekly for the duration of 12 weeks
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Pacing of Exercise
Time Frame: Biweekly for the duration of 12 weeks
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Number of steps in one minute will be counted during exercise session.
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Biweekly for the duration of 12 weeks
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Lap time
Time Frame: Biweekly for the duration of 12 weeks
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Time taken to complete one lap will be recorded for each biweekly exercise session.
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Biweekly for the duration of 12 weeks
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Playcounts
Time Frame: 8 week duration
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Number of plays of the audio file per week will be recorded
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8 week duration
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Future Hospitalizations and/or Mortality
Time Frame: Within 2 years
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Participants will be tracked longitudinally throughout health service encounters including physician visits, hospitalizations, and mortality.
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Within 2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dr. David Alter, MD,PhD,FRCPC, Toronto Rehabilitation Institute
Publications and helpful links
General Publications
- Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Nocon M, Hiemann T, Muller-Riemenschneider F, Thalau F, Roll S, Willich SN. Association of physical activity with all-cause and cardiovascular mortality: a systematic review and meta-analysis. Eur J Cardiovasc Prev Rehabil. 2008 Jun;15(3):239-46. doi: 10.1097/HJR.0b013e3282f55e09.
- Turk-Adawi KI, Oldridge NB, Tarima SS, Stason WB, Shepard DS. Cardiac rehabilitation patient and organizational factors: what keeps patients in programs? J Am Heart Assoc. 2013 Oct 21;2(5):e000418. doi: 10.1161/JAHA.113.000418.
- Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.
- Goel K, Lennon RJ, Tilbury RT, Squires RW, Thomas RJ. Impact of cardiac rehabilitation on mortality and cardiovascular events after percutaneous coronary intervention in the community. Circulation. 2011 May 31;123(21):2344-52. doi: 10.1161/CIRCULATIONAHA.110.983536. Epub 2011 May 16.
- Davies P, Taylor F, Beswick A, Wise F, Moxham T, Rees K, Ebrahim S. Promoting patient uptake and adherence in cardiac rehabilitation. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD007131. doi: 10.1002/14651858.CD007131.pub2.
- Brownley KA, McMurray RG, Hackney AC. Effects of music on physiological and affective responses to graded treadmill exercise in trained and untrained runners. Int J Psychophysiol. 1995 Apr;19(3):193-201. doi: 10.1016/0167-8760(95)00007-f.
- Alter DA, Wijeysundera HC, Franklin B, Austin PC, Chong A, Oh PI, Tu JV, Stukel TA. Obesity, lifestyle risk-factors, and health service outcomes among healthy middle-aged adults in Canada. BMC Health Serv Res. 2012 Aug 4;12:238. doi: 10.1186/1472-6963-12-238.
- Alter DA, Zagorski B, Marzolini S, Forhan M, Oh PI. On-site programmatic attendance to cardiac rehabilitation and the healthy-adherer effect. Eur J Prev Cardiol. 2015 Oct;22(10):1232-46. doi: 10.1177/2047487314544084. Epub 2014 Jul 30.
- Brewer, BW., Van Raalte, JL, & Linder, DE. (1996). Attentional Focus and Endurance Performance. Applied Research in Coaching and Athletics Annual. 11:1-14.
- Chen JL, Zatorre RJ, Penhune VB. Interactions between auditory and dorsal premotor cortex during synchronization to musical rhythms. Neuroimage. 2006 Oct 1;32(4):1771-81. doi: 10.1016/j.neuroimage.2006.04.207. Epub 2006 Jun 14.
- Hardy, CJ., & Rejeski, WJ. (1989). Not What, but How One Feels: the Measurement of Affect During Exercise. J. Sport Exerc Psychol. 11:304-317
- Kendzierski D, DeCarlo KJ. Physical Activity Enjoyment Scale: Two validation studies. Journal of Sport & Exercise Psychology. 1991;13(1):50-64.
- Measuring Enjoyment of Physical Activity in Children: Validation of the Physical Activity Enjoyment Scale. J Appl Sport Psychol. 2009 Jan 1;21(S1):S116-S129. doi: 10.1080/10413200802593612.
- Nakamura PM, Pereira G, Papini CB, Nakamura FY, Kokubun E. Effects of preferred and nonpreferred music on continuous cycling exercise performance. Percept Mot Skills. 2010 Feb;110(1):257-64. doi: 10.2466/PMS.110.1.257-264.
- Pinch, TJ., & Bijsterveld, K. (2012). The Oxford Handbook of Sound Studies. New York: Oxford University Press.
- Simpson SD, Karageorghis CI. The effects of synchronous music on 400-m sprint performance. J Sports Sci. 2006 Oct;24(10):1095-102. doi: 10.1080/02640410500432789.
- Svebak, S., & Murgatroyd, S. (1985). Metamotivational dominance: A multi-method validation of reversal theory constructs. Journal of Personality and Social Psychology. 48: 107-116.
- Tammen, VV. (1996). Elite middle and long distance runner's associative/dissociative coping. J. Apple. Sport Psychol. 8:1-810
- Taylor RS, Unal B, Critchley JA, Capewell S. Mortality reductions in patients receiving exercise-based cardiac rehabilitation: how much can be attributed to cardiovascular risk factor improvements? Eur J Cardiovasc Prev Rehabil. 2006 Jun;13(3):369-74. doi: 10.1097/01.hjr.0000199492.00967.11.
- Thompson DR, Bowman GS, Kitson AL, de Bono DP, Hopkins A. Cardiac rehabilitation services in England and Wales: a national survey. Int J Cardiol. 1997 May 23;59(3):299-304. doi: 10.1016/s0167-5273(97)02951-3.
- WHO. Preventing chronic diseases: A vital investment (2005) [accessed September 20, 2015].http://www .who.int/chp /chronic_disease_report/full_report .pdf.
- Woodcock J, Franco OH, Orsini N, Roberts I. Non-vigorous physical activity and all-cause mortality: systematic review and meta-analysis of cohort studies. Int J Epidemiol. 2011 Feb;40(1):121-38. doi: 10.1093/ije/dyq104. Epub 2010 Jul 14.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-9839
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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