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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02946060
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : April 20, 2020
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Dr. David Alter, Toronto Rehabilitation Institute

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.

Condition or disease Intervention/treatment Phase
Physical Activity Other: Audiobooks Other: Tempo-pace synchronized playlists Other: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

Drug Information available for: Gelusil

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.
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.
Other: Audiobooks
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. Pacing of Exercise [ Time Frame: Biweekly for the duration of 12 weeks ]
    Number of steps in one minute will be counted during exercise session.

  7. 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.

  8. Playcounts [ Time Frame: 8 week duration ]
    Number of plays of the audio file per week will be recorded

  9. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Cardiac Rehabilitation and Prevention Program
Toronto, Ontario, Canada, M4G 2V6
Sponsors and Collaborators
Toronto Rehabilitation Institute
Heart and Stroke Foundation of Canada
Investigators
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Principal Investigator: Dr. David Alter, MD,PhD,FRCPC Toronto Rehabilitation Institute
Publications:
Brewer, BW., Van Raalte, JL, & Linder, DE. (1996). Attentional Focus and Endurance Performance. Applied Research in Coaching and Athletics Annual. 11:1-14.
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.
Pinch, TJ., & Bijsterveld, K. (2012). The Oxford Handbook of Sound Studies. New York: Oxford University Press.
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
WHO. Preventing chronic diseases: A vital investment (2005) [accessed September 20, 2015].http://www .who.int/chp /chronic_disease_report/full_report .pdf.

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Responsible Party: Dr. David Alter, Principal Investigator, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT02946060    
Other Study ID Numbers: 15-9839
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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TEMPO
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs