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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Dr. David Alter, Toronto Rehabilitation Institute.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01752595
First Posted: December 19, 2012
Last Update Posted: November 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ontario Centres of Excellence
University of Toronto
Information provided by (Responsible Party):
Dr. David Alter, Toronto Rehabilitation Institute
  Purpose

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).


Condition Intervention
Myocardial Infarction Compliance Behavior Patient Compliance Behavioral: Preference Based Rhythmic Auditory Stimulation Music Other: Preference Based Music Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment Study

Resource links provided by NLM:


Further study details as provided by Dr. David Alter, Toronto Rehabilitation Institute:

Primary Outcome Measures:
  • Duration of physical activity [ Time Frame: 3 months ]
    The primary outcome will be the total weekly physical activity volume as determined using triaxial accelerometers.


Secondary Outcome Measures:
  • On-site program attendance [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 months ]
    We will track the number of song plays on each patients playlist

  • Study recruitment and drop-out [ Time Frame: 3 months ]
    We will determine the proportion of patients screened, recruited, and who completed the study protocol


Other Outcome Measures:
  • Interview and Focus Group [ Time Frame: 3 months ]
    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).


Estimated Enrollment: 35
Study Start Date: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752595


Locations
Canada, Ontario
Toronto Cardiac Rehabilitation Institute
Toronto, Ontario, Canada, M4G 1R7
Sponsors and Collaborators
Toronto Rehabilitation Institute
Ontario Centres of Excellence
University of Toronto
Investigators
Principal Investigator: Dr. David Alter Toronto Rehabilitation Institute
  More Information

Publications:
Alter DA, Iron K, Austin PC, Naylor CD; SESAMI Study Group. Socioeconomic status, service patterns, and perceptions of care among survivors of acute myocardial infarction in Canada. JAMA. 2004 Mar 3;291(9):1100-7.
Chan RH, Gordon NF, Chong A, Alter DA; Socio-Economic and Acute Myocardial Infarction Investigators. Influence of socioeconomic status on lifestyle behavior modifications among survivors of acute myocardial infarction. Am J Cardiol. 2008 Dec 15;102(12):1583-8. doi: 10.1016/j.amjcard.2008.08.022. Epub 2008 Oct 9.
De Angelis C, Bunker S, Schoo A. Exploring the barriers and enablers to attendance at rural cardiac rehabilitation programs. Aust J Rural Health. 2008 Jun;16(3):137-42. doi: 10.1111/j.1440-1584.2008.00963.x.
Molloy GJ, Perkins-Porras L, Strike PC, Steptoe A. Social networks and partner stress as predictors of adherence to medication, rehabilitation attendance, and quality of life following acute coronary syndrome. Health Psychol. 2008 Jan;27(1):52-8. doi: 10.1037/0278-6133.27.1.52.
Hagan NA, Botti MA, Watts RJ. Financial, family, and social factors impacting on cardiac rehabilitation attendance. Heart Lung. 2007 Mar-Apr;36(2):105-13.
Worcester MU, Murphy BM, Mee VK, Roberts SB, Goble AJ. Cardiac rehabilitation programmes: predictors of non-attendance and drop-out. Eur J Cardiovasc Prev Rehabil. 2004 Aug;11(4):328-35.
Glazer KM, Emery CF, Frid DJ, Banyasz RE. Psychological predictors of adherence and outcomes among patients in cardiac rehabilitation. J Cardiopulm Rehabil. 2002 Jan-Feb;22(1):40-6.
Grace SL, Gravely-Witte S, Brual J, Monette G, Suskin N, Higginson L, Alter DA, Stewart DE. Contribution of patient and physician factors to cardiac rehabilitation enrollment: a prospective multilevel study. Eur J Cardiovasc Prev Rehabil. 2008 Oct;15(5):548-56. doi: 10.1097/HJR.0b013e328305df05.
Bandura A. Health promotion by social cognitive means. Health Educ Behav. 2004 Apr;31(2):143-64.
(10) Van Noorden, L., & Moelants, D. Resonance in the perception of musical pulse. Journal of New Music Research 1999, 43-66
van der Vlist B, Bartneck C, Mäueler S. moBeat: Using interactive music to guide and motivate users during aerobic exercising. Appl Psychophysiol Biofeedback. 2011 Jun;36(2):135-45. doi: 10.1007/s10484-011-9149-y.
Konlaan BB, Bygren LO, Johansson SE. Visiting the cinema, concerts, museums or art exhibitions as determinant of survival: a Swedish fourteen-year cohort follow-up. Scand J Public Health. 2000 Sep;28(3):174-8.
Konlaan BB, Björby N, Bygren LO, Weissglas G, Karlsson LG, Widmark M. Attendance at cultural events and physical exercise and health: a randomized controlled study. Public Health. 2000 Sep;114(5):316-9.
Marrero DG, Fremion AS, Golden MP. Improving compliance with exercise in adolescents with insulin-dependent diabetes mellitus: results of a self-motivated home exercise program. Pediatrics. 1988 Apr;81(4):519-25.
Rhodes RE, Warburton DE, Bredin SS. Predicting the effect of interactive video bikes on exercise adherence: An efficacy trial. Psychol Health Med. 2009 Dec;14(6):631-40. doi: 10.1080/13548500903281088.
O'Konski M, Bane C, Hettinga J, Krull K. Comparative effectiveness of exercise with patterned sensory enhanced music and background music for long-term care residents. J Music Ther. 2010 Summer;47(2):120-36.
Johnson G, Otto D, Clair AA. The effect of instrumental and vocal music on adherence to a physical rehabilitation exercise program with persons who are elderly. J Music Ther. 2001 Summer;38(2):82-96.
Edworthy J, Waring H. The effects of music tempo and loudness level on treadmill exercise. Ergonomics. 2006 Dec 15;49(15):1597-610.
Karageorghis CI, Jones L, Priest DL, Akers RI, Clarke A, Perry JM, Reddick BT, Bishop DT, Lim HB. Revisiting the relationship between exercise heart rate and music tempo preference. Res Q Exerc Sport. 2011 Jun;82(2):274-84. Erratum in: Res Q Exerc Sport. 2011 Sep;82(3):592.
Bradt J, Dileo C. Music for stress and anxiety reduction in coronary heart disease patients. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD006577. doi: 10.1002/14651858.CD006577.pub2. Review. Update in: Cochrane Database Syst Rev. 2013;12:CD006577.
Brownley KA, McMurray RG, Hackney AC. Effects of music on physiological and affective responses to graded treadmill exercise in trained and untrained runners. Int J Psychophysiol. 1995 Apr;19(3):193-201.
(22) Matesic B, Cromartie F, Effects Music Has on Lap Pace, Heart Rate and Perceived Exertion Rate During a 20-Minute Self-Paced, Masters' Thesis 2011
Everett B, Salamonson Y, Davidson PM. Bandura's exercise self-efficacy scale: validation in an Australian cardiac rehabilitation setting. Int J Nurs Stud. 2009 Jun;46(6):824-9. doi: 10.1016/j.ijnurstu.2009.01.016. Epub 2009 Mar 4.
Garatachea N, Torres Luque G, González Gallego J. Physical activity and energy expenditure measurements using accelerometers in older adults. Nutr Hosp. 2010 Mar-Apr;25(2):224-30. Review.
Patel SA, Benzo RP, Slivka WA, Sciurba FC. Activity monitoring and energy expenditure in COPD patients: a validation study. COPD. 2007 Jun;4(2):107-12.
Slootmaker SM, Chin A Paw MJ, Schuit AJ, van Mechelen W, Koppes LL. Concurrent validity of the PAM accelerometer relative to the MTI Actigraph using oxygen consumption as a reference. Scand J Med Sci Sports. 2009 Feb;19(1):36-43. doi: 10.1111/j.1600-0838.2007.00740.x. Epub 2008 Feb 4.
Bassett DR Jr, Ainsworth BE, Swartz AM, Strath SJ, O'Brien WL, King GA. Validity of four motion sensors in measuring moderate intensity physical activity. Med Sci Sports Exerc. 2000 Sep;32(9 Suppl):S471-80.
Anshel MH, Marisi D. Effect of music and rhythm on physical performance. Res Q. 1978 May;49(2):109-13.
Cho, Jeongmin (2009). The effect of music therapy on mood, perceived exertion, and exercise adherence of patients participating in a rehabilitative upper extremity exercise program. University of Kansas, Master's Thesis: Music Education & Music Therapy.
Copeland BL, Franks BD. Effects of types and intensities of background music on treadmill endurance. J Sports Med Phys Fitness. 1991 Mar;31(1):100-3.
Gfeller, K. (1988). Musical components and styles preferred by young adults for aerobic fitness activities. Journal of Music Therapy, 25, 28-43.
Hayakawa Y, Miki H, Takada K, Tanaka K. Effects of music on mood during bench stepping exercise. Percept Mot Skills. 2000 Feb;90(1):307-14.
Karageorghis CI, Mouzourides DA, Priest DL, Sasso TA, Morrish DJ, Walley CJ. Psychophysical and ergogenic effects of synchronous music during treadmill walking. J Sport Exerc Psychol. 2009 Feb;31(1):18-36.
Karageorghis, C.I., Priest, D.L., Williams, L.S., Hirani, R.M., Lannon, K.M., & Bates, B.J. (2010). Ergogenic and psychological effects of synchronous music during circuit-type exercise. Psychology of Sport and Exercise, 11, 551-559.
Pearce, K. A. (1981). Effects of different types of music on physical strength. Perceptual and Motor Skills, 53, 351-352.
Van Noorden, L., & Moelants, D. (1999). Resonance in the perception of musical pulse. Journal of New Music Research, 28, 43-66
Zimmerman LM, Pierson MA, Marker J. Effects of music on patient anxiety in coronary care units. Heart Lung. 1988 Sep;17(5):560-6.
White JM. Effects of relaxing music on cardiac autonomic balance and anxiety after acute myocardial infarction. Am J Crit Care. 1999 Jul;8(4):220-30.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. David Alter, Dr. David Alter, MD, PhD, FRCPC, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT01752595     History of Changes
Other Study ID Numbers: 12-035
First Submitted: December 3, 2012
First Posted: December 19, 2012
Last Update Posted: November 26, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases


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