The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment - II
NCT ID: NCT02946060
Last Updated: 2020-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
169 participants
INTERVENTIONAL
2016-02-29
2017-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment
NCT01752595
Running Title: Walking to Music and in Silence on a Treadmill
NCT04856345
Effect of Motor Entrainment to Auditory Cues and Music During Walking on Quality of Movement and Perceived Fatigue in Persons With Multiple Sclerosis (PwMS)
NCT03281330
Effect of Daily Music Listening on Stroke Recovery
NCT01749709
Multimodal Musical Stimulation for Healthy Neurocognitive Aging
NCT06229093
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Usual Care
iPods containing either a silent track or white noise
Audiobooks
Participants in this arm will receive iPods with Audiobooks based on their preferred genres.
Audiobooks
iPods with audiobooks
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.
Tempo-pace synchronized playlists
Playlists with or without RAS
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Audiobooks
iPods with audiobooks
Tempo-pace synchronized playlists
Playlists with or without RAS
Usual Care
iPods containing either a silent track or white noise
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 with significant communication impairments
* Participants currently enrolled in another intervention study
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Heart and Stroke Foundation of Canada
OTHER
Toronto Rehabilitation Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. David Alter
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dr. David Alter, MD,PhD,FRCPC
Role: PRINCIPAL_INVESTIGATOR
Toronto Rehabilitation Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cardiac Rehabilitation and Prevention Program
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
Brewer, BW., Van Raalte, JL, & Linder, DE. (1996). Attentional Focus and Endurance Performance. Applied Research in Coaching and Athletics Annual. 11:1-14.
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.
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.
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.
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.
Hardy, CJ., & Rejeski, WJ. (1989). Not What, but How One Feels: the Measurement of Affect During Exercise. J. Sport Exerc Psychol. 11:304-317
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
15-9839
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.