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

Toronto Rehabilitation Institute

Status: Completed

Conditions: Compliance Behavior; Patient Compliance; Myocardial Infarction

Treatments: Behavioral: Preference Based Rhythmic Auditory Stimulation Music; Other: Preference Based Music Intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01752595

12-035

Details and patient eligibility

About

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).

Enrollment: 34 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

34 participants in 3 patient groups

Standard

No Intervention group

Description:

Subjects randomized to this group will receive standard, usual care with no intervention.

Preference Based Music Intervention

Active Comparator group

Description:

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.

Treatment:

Other: Preference Based Music Intervention

Preference Based Rhythmic Auditory Stimulation Music

Active Comparator group

Description:

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.

Treatment:

Behavioral: Preference Based Rhythmic Auditory Stimulation Music