The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment (MAINTAIN)
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 N.A.M.E 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. 45 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 is feasibility. We will also analyze the impact of a preference-based music intervention based on adherence to the exercise program (off-site activity levels), 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).
Behavioral: Preference Based Rhythmic Auditory Stimulation Music
Other: Preference Based Music Intervention
|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 - A Feasibility Study|
- Participation Rates [ Time Frame: 3 months ] [ Designated as safety issue: No ]The primary outcome reflects the feasibility of this study. To assess the feasibility of this study, participation rates (on-site attendance, reported and measured usage of gadgets, interview and focus group attendance and responses) will be recorded.
- 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
- 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).
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
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.
|Toronto Cardiac Rehabilitation Institute|
|Toronto, Ontario, Canada, M4G 1R7|
|Principal Investigator:||Dr. David Alter||Toronto Rehabilitation Institute|