Myocardial Infarction Clinical Trial
— MAINTAINOfficial title:
The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment Study
NCT number | NCT01752595 |
Other study ID # | 12-035 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2012 |
Est. completion date | December 2013 |
Verified date | October 2020 |
Source | Toronto Rehabilitation Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 34 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto Cardiac Rehabilitation Institute | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Toronto Rehabilitation Institute | Ontario Centres of Excellence, University of Toronto |
Canada,
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* Note: There are 38 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Interview and Focus Group | 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 | |
Primary | Duration of physical activity | The primary outcome will be the total weekly physical activity volume as determined using triaxial accelerometers. | 3 months | |
Secondary | On-site program attendance | Adherence will be measured quantitatively by assessing the number of missed appointments vs. amount of scheduled appointments. | 3 months | |
Secondary | Change in Cardio Pulmonary Assessment Score | 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 | |
Secondary | Changes in Stafford Self-Efficacy Questionnaire/Cardiac Self-Efficacy Questionnaire Scores | Changes in self efficacy will be measured using the combined score of two self-efficacy questionnaires administered by Toronto Rehabilitation Institute | Baseline, 3 months | |
Secondary | Audio-play list use | We will track the number of song plays on each patients playlist | 3 months | |
Secondary | Study recruitment and drop-out | We will determine the proportion of patients screened, recruited, and who completed the study protocol | 3 months |
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