The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment - II

NCT02946060 | Completed

• 1 other identifier: 15-9839
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (1)

• Average volume of physical activity per week per intervention

  The activity monitor will be worn each week for 12 weeks. Average minutes of physical activity per week will be compared between groups.

  12 weeks

Secondary Outcomes (9)

• Affect measured by Feeling Scale

  Biweekly for the duration of 12 weeks

• Arousal measured by Score on Felt Arousal

  Biweekly for the duration of 12 weeks

• Perceived Exertion measured by Rate of Perceived Exertion Scale

  Biweekly for the duration of 12 weeks

• Dissociative Attention measured by the Tammen's Scale

  Biweekly for the duration of 12 weeks

• Focus measured by the Focus Questionnaire

  Biweekly for the duration of 12 weeks

Study Arms (3)

Usual Care

SHAM COMPARATOR

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

Audiobooks

ACTIVE COMPARATOR

Participants in this arm will receive iPods with Audiobooks based on their preferred genres.

Other: Audiobooks

Tempo-pace Synchronized Playlists

EXPERIMENTAL

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

Interventions

Audiobooks OTHER

iPods with audiobooks

Audiobooks

Tempo-pace synchronized playlists OTHER

Playlists with or without RAS

Tempo-pace Synchronized Playlists

Usual Care OTHER

iPods containing either a silent track or white noise

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Toronto Rehabilitation Institute: lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (1)

Cardiac Rehabilitation and Prevention Program

Toronto, Ontario, M4G 2V6, Canada

Location

Related Publications (23)

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  PMID: 7154893 BACKGROUND

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  BACKGROUND

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  PMID: 16777432 BACKGROUND

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  PMID: 20614453 BACKGROUND

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  PMID: 21576654 BACKGROUND

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  BACKGROUND

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  PMID: 21735386 BACKGROUND

• Kendzierski D, DeCarlo KJ. Physical Activity Enjoyment Scale: Two validation studies. Journal of Sport & Exercise Psychology. 1991;13(1):50-64.

  BACKGROUND

• 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.

  PMID: 20209028 BACKGROUND

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  PMID: 20391890 BACKGROUND

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  PMID: 18525377 BACKGROUND

• Pinch, TJ., & Bijsterveld, K. (2012). The Oxford Handbook of Sound Studies. New York: Oxford University Press.

  BACKGROUND

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  BACKGROUND

• Tammen, VV. (1996). Elite middle and long distance runner's associative/dissociative coping. J. Apple. Sport Psychol. 8:1-810

  BACKGROUND

• 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.

  PMID: 16926666 BACKGROUND

• 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.

  PMID: 9183047 BACKGROUND

• 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.

  PMID: 24145743 BACKGROUND

• WHO. Preventing chronic diseases: A vital investment (2005) [accessed September 20, 2015].http://www .who.int/chp /chronic_disease_report/full_report .pdf.

  BACKGROUND

• 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.

  PMID: 20630992 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Sound Recordings

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Dr. David Alter, MD,PhD,FRCPC

  Toronto Rehabilitation Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: October 26, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)