The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment
- Conditions
- Compliance BehaviorPatient ComplianceMyocardial Infarction
- Interventions
- Other: Preference Based Music InterventionBehavioral: Preference Based Rhythmic Auditory Stimulation Music
- Registration Number
- NCT01752595
- Lead Sponsor
- Toronto Rehabilitation Institute
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Preference Based Music Intervention 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. Preference Based Rhythmic Auditory Stimulation Music 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.
- Primary Outcome Measures
Name Time Method Duration of physical activity 3 months The primary outcome will be the total weekly physical activity volume as determined using triaxial accelerometers.
- Secondary Outcome Measures
Name Time Method Study recruitment and drop-out 3 months We will determine the proportion of patients screened, recruited, and who completed the study protocol
On-site program attendance 3 months Adherence will be measured quantitatively by assessing the number of missed appointments vs. amount of scheduled appointments.
Change in Cardio Pulmonary Assessment Score 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.
Changes in Stafford Self-Efficacy Questionnaire/Cardiac Self-Efficacy Questionnaire Scores Baseline, 3 months 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 3 months We will track the number of song plays on each patients playlist
Trial Locations
- Locations (1)
Toronto Cardiac Rehabilitation Institute
🇨🇦Toronto, Ontario, Canada