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

October 8, 2020 updated by: Dr. David Alter, Toronto Rehabilitation Institute

The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment Study

Auditory motor-coupling has been shown to induce neural-entrainment that can synchronize walking-pace with sonic tempo. The extent to which acoustical-motor entrainment can induce longer-term changes to physical activity behaviours remains unclear.

Cardiac rehabilitation is essential and is associated with irrefutable mortality benefits for patients following an acute cardiac event. Randomized clinical trials have demonstrated a 25-50% improvement in survival as compared to controls; however, as many as 50% of patients will dropout of such programs prior to completion, which undermines these morbidity and mortality benefits (37; 54). Research exploring ways to improve compliance to such programs has suggested that the incorporation of music and other such holistic, patient-centered interventions into a rehabilitation/exercise program is associated with improved motivation, endurance and satisfaction amongst cardiac rehabilitation participants. The MAINTAIN study has been designed to conduct a feasibility evaluation on the effects of a preference-based music intervention on adherence to the cardiac rehabilitation program at Toronto Rehabilitation Institute. The primary objective of the trial is to evaluate the feasibility of the implementation of such a protocol within the context of the program.

This is a two-arm, block 2:1 randomized trial. 35 patients participating in cardiac rehabilitation at Toronto Rehabilitation: Cardiac Rehabilitation and Secondary Prevention Program will be recruited and participants will be randomized into: 1) control (standard, usual care); and, 2) music intervention. The randomization process employed will be a blocked 2:1 strategy, whereby subjects are randomized to the music treatment arms 2:1. All those patients randomized into arm 2 will be equally randomized into either (2) preference-based music intervention, (3) preference-based music enhanced with RAS. The primary outcome measure will be weekly physical activity over a 3 month duration as measured using tri-axial accelerometers. We will also analyze the impact of a preference-based music intervention based on audio playlist utilization, self-reported sitting times ,exercise-times, on-site attendance to the cardiac rehabilitation program (attendance), peak oxygen uptake (VO2) (stress-test), and self-efficacy levels (self-efficacy questionnaires). These measures will be collected and analyzed throughout the course of the intervention (3 months).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4G 1R7
        • Toronto Cardiac Rehabilitation Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • English-speaking patients, who are participating in and have been declared medically stable for out-patient cardiac rehabilitation, will be recruited from the Toronto Rehabilitation Institute's Cardiac Rehabilitation and Secondary Prevention Program.

Exclusion Criteria:

  • Participants who are unable to wear the MP3 device or the activity monitoring device due to medical or non-medical issues will be excluded from this study.
  • Subjects that have a medical history of seizure disorders, previous neurosurgery, or known head trauma will be excluded from this study.
  • Subjects that have received a bicycle-based exercise prescription.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard
Subjects randomized to this group will receive standard, usual care with no intervention.
Active Comparator: Preference Based Music Intervention
Subjects randomized to this arm will receive an iPod player and an activity monitoring device. The iPod will be loaded with patient indicated music preferences that is synched to the patients pace prescription. Subjects will be asked to use their iPod player during off-site exercise periods.
Other: Preference Based Music Intervention
Active Comparator: Preference Based Rhythmic Auditory Stimulation Music
Subjects randomized to this arm will receive an iPod player and an activity monitoring device. The iPod will be loaded with patient indicated music preferences that is synched to the patients pace prescription. Subjects will be asked to use their iPod player during off-site exercise periods. Rhythmic Auditory Stimulation (accentuation of beats, frequencies) will be added to the music subliminally.
Behavioral: Preference Based Rhythmic Auditory Stimulation Music
Patients that have been randomized into arms 2 and 3 will be blinded to the intervention they are receiving (i.e. preference-based playlist vs. preference-based playlist that has been edited to include Rhythmic Auditory Stimulation (RAS). RAS drives synchronous neural oscillation (entrainment) and functions in two ways: (1) facilitates pace and heart-rate synchrony and (2) facilitates brain state dominance (getting into the zone). RAS will be accomplished through: (1) sequencing of subject self-selected music based on tempo, (2) accentuation of the rhythmic driving pulse with added percussive-type sounds, (3) addition of binaurally detuned pitches to follow bass lines at brain-state target frequencies (e.g., 8 Hz alpha, or 16 Hz beta), and (4) the addition of binaurally detuned "background" sounds (e.g., low frequency hum) at target Hz frequencies. RAS is implemented as inherent and natural to the music and may remain imperceptible to most.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of physical activity
Time Frame: 3 months
The primary outcome will be the total weekly physical activity volume as determined using triaxial accelerometers.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
On-site program attendance
Time Frame: 3 months
Adherence will be measured quantitatively by assessing the number of missed appointments vs. amount of scheduled appointments.
3 months
Change in Cardio Pulmonary Assessment Score
Time Frame: Baseline, 3 months
Fitness levels will be measured by assessing peak VO2 (ml/kg-1* min-1), an objective, clinical measure of the volume of oxygen consumed while exercising at the maximum capacity. Those with higher VO2max values are more fit and can exercise more intensely, indicating a greater functional capacity than those with lower VO2max values.
Baseline, 3 months
Changes in Stafford Self-Efficacy Questionnaire/Cardiac Self-Efficacy Questionnaire Scores
Time Frame: Baseline, 3 months
Changes in self efficacy will be measured using the combined score of two self-efficacy questionnaires administered by Toronto Rehabilitation Institute
Baseline, 3 months
Audio-play list use
Time Frame: 3 months
We will track the number of song plays on each patients playlist
3 months
Study recruitment and drop-out
Time Frame: 3 months
We will determine the proportion of patients screened, recruited, and who completed the study protocol
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interview and Focus Group
Time Frame: 3 months
Tertiary outcomes of the study will include information gathered regarding music playlist preferences and subjective opinions about the role of music in exercise programs through post-intervention interviews (attached). Other secondary outcomes include the energy expenditure and activity time as recorded over the entire three-month period by the activity monitoring device and MP3 device (this data collected every 2 weeks).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Toronto Rehabilitation Institute

Collaborators

University of Toronto
Ontario Centres of Excellence

Investigators

  • Principal Investigator: Dr. David Alter, Toronto Rehabilitation Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

December 14, 2012

First Posted (Estimate)

December 19, 2012

Study Record Updates

Last Update Posted (Actual)

October 9, 2020

Last Update Submitted That Met QC Criteria

October 8, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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