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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ontario Centres of Excellence
University of Toronto
Information provided by (Responsible Party):
Dr. David Alter, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT01752595
First received: December 3, 2012
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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).


Condition Intervention
Myocardial Infarction
Compliance Behavior
Patient Compliance
Behavioral: Preference Based Rhythmic Auditory Stimulation Music
Other: Preference Based Music Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment Study

Resource links provided by NLM:


Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:
  • Duration of physical activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The primary outcome will be the total weekly physical activity volume as determined using triaxial accelerometers.


Secondary Outcome Measures:
  • On-site program attendance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Adherence will be measured quantitatively by assessing the number of missed appointments vs. amount of scheduled appointments.

  • Change in Cardio Pulmonary Assessment Score [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]
    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.

  • Changes in Stafford Self-Efficacy Questionnaire/Cardiac Self-Efficacy Questionnaire Scores [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]
    Changes in self efficacy will be measured using the combined score of two self-efficacy questionnaires administered by Toronto Rehabilitation Institute

  • Audio-play list use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    We will track the number of song plays on each patients playlist

  • Study recruitment and drop-out [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    We will determine the proportion of patients screened, recruited, and who completed the study protocol


Other Outcome Measures:
  • Interview and Focus Group [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 35
Study Start Date: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01752595

Locations
Canada, Ontario
Toronto Cardiac Rehabilitation Institute
Toronto, Ontario, Canada, M4G 1R7
Sponsors and Collaborators
Toronto Rehabilitation Institute
Ontario Centres of Excellence
University of Toronto
Investigators
Principal Investigator: Dr. David Alter Toronto Rehabilitation Institute
  More Information

Publications:
(11) Konlaan BB, Bygren Lo, Johansson SE. Visiting the cinema, concerts, museums or art exhibitions as determinants of survival: a Swedish fourteen year cohort follow-up. Scanj J Public Health 2000, 74-8.
(14) Rhodes RE, Warburton DE, Brendon SS. Predicting the effect of interactive video bikes on exercise adherence. An efficacy trial. Psychol Health Med. 2009; 14 (6): 631-40.

Responsible Party: Dr. David Alter, Dr. David Alter, MD, PhD, FRCPC, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT01752595     History of Changes
Other Study ID Numbers: 12-035
Study First Received: December 3, 2012
Last Updated: November 25, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014