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

December 3, 2012
November 25, 2013
November 2012
December 2013   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01752595 on ClinicalTrials.gov Archive Site
  • 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
  • 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).
Same as current
 
The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment
The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment Study

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Myocardial Infarction
  • Compliance Behavior
  • Patient Compliance
  • 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.
  • Other: Preference Based Music Intervention
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Preference Based Rhythmic Auditory Stimulation Music

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
35
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01752595
12-035
Not Provided
Dr. David Alter, Toronto Rehabilitation Institute
Toronto Rehabilitation Institute
  • Ontario Centres of Excellence
  • University of Toronto
Principal Investigator: Dr. David Alter Toronto Rehabilitation Institute
Toronto Rehabilitation Institute
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP