Ignite Creation Date:
2025-12-24 @ 1:55 PM
Ignite Modification Date:
2026-04-15 @ 4:46 PM
Study NCT ID:
NCT01752595
Status:
COMPLETED
Last Update Posted:
2020-10-09
First Post:
2012-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-08', 'studyFirstSubmitDate': '2012-12-03', 'studyFirstSubmitQcDate': '2012-12-14', 'lastUpdatePostDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Interview and Focus Group', 'timeFrame': '3 months', 'description': '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).'}], 'primaryOutcomes': [{'measure': 'Duration of physical activity', 'timeFrame': '3 months', 'description': 'The primary outcome will be the total weekly physical activity volume as determined using triaxial accelerometers.'}], 'secondaryOutcomes': [{'measure': 'On-site program attendance', 'timeFrame': '3 months', 'description': 'Adherence will be measured quantitatively by assessing the number of missed appointments vs. amount of scheduled appointments.'}, {'measure': 'Change in Cardio Pulmonary Assessment Score', 'timeFrame': 'Baseline, 3 months', 'description': '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.'}, {'measure': 'Changes in Stafford Self-Efficacy Questionnaire/Cardiac Self-Efficacy Questionnaire Scores', 'timeFrame': 'Baseline, 3 months', 'description': 'Changes in self efficacy will be measured using the combined score of two self-efficacy questionnaires administered by Toronto Rehabilitation Institute'}, {'measure': 'Audio-play list use', 'timeFrame': '3 months', 'description': 'We will track the number of song plays on each patients playlist'}, {'measure': 'Study recruitment and drop-out', 'timeFrame': '3 months', 'description': 'We will determine the proportion of patients screened, recruited, and who completed the study protocol'}]}, 'conditionsModule': {'conditions': ['Myocardial Infarction', 'Compliance Behavior', 'Patient Compliance']}, 'referencesModule': {'references': [{'pmid': '14996779', 'type': 'BACKGROUND', 'citation': 'Alter DA, Iron K, Austin PC, Naylor CD; SESAMI Study Group. 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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.'}, {'pmid': '17362791', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1016/j.hrtlng.2006.05.010.'}, {'pmid': '15292767', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1097/01.hjr.0000137083.20844.54.'}, {'pmid': '11839996', 'type': 'BACKGROUND', 'citation': 'Glazer KM, Emery CF, Frid DJ, Banyasz RE. Psychological predictors of adherence and outcomes among patients in cardiac rehabilitation. 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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.'}, {'pmid': '21141769', 'type': 'BACKGROUND', 'citation': "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. doi: 10.1093/jmt/47.2.120."}, {'pmid': '11469917', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1093/jmt/38.2.82.'}, {'pmid': '17090506', 'type': 'BACKGROUND', 'citation': 'Edworthy J, Waring H. The effects of music tempo and loudness level on treadmill exercise. 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Int J Psychophysiol. 1995 Apr;19(3):193-201. doi: 10.1016/0167-8760(95)00007-f.'}, {'type': 'BACKGROUND', 'citation': "(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"}, {'pmid': '19261281', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '20449530', 'type': 'BACKGROUND', 'citation': 'Garatachea N, Torres Luque G, Gonzalez Gallego J. Physical activity and energy expenditure measurements using accelerometers in older adults. Nutr Hosp. 2010 Mar-Apr;25(2):224-30.'}, {'pmid': '17530503', 'type': 'BACKGROUND', 'citation': 'Patel SA, Benzo RP, Slivka WA, Sciurba FC. Activity monitoring and energy expenditure in COPD patients: a validation study. 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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."}, {'pmid': '1861474', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Gfeller, K. (1988). Musical components and styles preferred by young adults for aerobic fitness activities. Journal of Music Therapy, 25, 28-43.'}, {'pmid': '10769915', 'type': 'BACKGROUND', 'citation': '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. doi: 10.2466/pms.2000.90.1.307.'}, {'pmid': '19325186', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1123/jsep.31.1.18.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Pearce, K. A. (1981). Effects of different types of music on physical strength. Perceptual and Motor Skills, 53, 351-352.'}, {'type': 'BACKGROUND', 'citation': 'Van Noorden, L., & Moelants, D. (1999). Resonance in the perception of musical pulse. Journal of New Music Research, 28, 43-66'}, {'pmid': '3417466', 'type': 'BACKGROUND', 'citation': 'Zimmerman LM, Pierson MA, Marker J. Effects of music on patient anxiety in coronary care units. Heart Lung. 1988 Sep;17(5):560-6.'}, {'pmid': '10392221', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26284164', 'type': 'DERIVED', 'citation': "Alter DA, O'Sullivan M, Oh PI, Redelmeier DA, Marzolini S, Liu R, Forhan M, Silver M, Goodman JM, Bartel LR. Synchronized personalized music audio-playlists to improve adherence to physical activity among patients participating in a structured exercise program: a proof-of-principle feasibility study. Sports Med Open. 2015;1(1):23. doi: 10.1186/s40798-015-0017-9. Epub 2015 May 8."}]}, 'descriptionModule': {'briefSummary': '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.\n\nCardiac 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.\n\nThis 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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.\n* Subjects that have a medical history of seizure disorders, previous neurosurgery, or known head trauma will be excluded from this study.\n* Subjects that have received a bicycle-based exercise prescription."}, 'identificationModule': {'nctId': 'NCT01752595', 'acronym': 'MAINTAIN', 'briefTitle': 'The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment', 'organization': {'class': 'OTHER', 'fullName': 'Toronto Rehabilitation Institute'}, 'officialTitle': 'The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment Study', 'orgStudyIdInfo': {'id': '12-035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard', 'description': 'Subjects randomized to this group will receive standard, usual care with no intervention.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Preference Based Music Intervention', '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.', 'interventionNames': ['Other: Preference Based Music Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Preference Based Rhythmic Auditory Stimulation Music', '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.', 'interventionNames': ['Behavioral: Preference Based Rhythmic Auditory Stimulation Music']}], 'interventions': [{'name': 'Preference Based Rhythmic Auditory Stimulation Music', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Preference Based Rhythmic Auditory Stimulation Music']}, {'name': 'Preference Based Music Intervention', 'type': 'OTHER', 'armGroupLabels': ['Preference Based Music Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4G 1R7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Cardiac Rehabilitation Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Dr. David Alter', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto Rehabilitation Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Toronto Rehabilitation Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ontario Centres of Excellence', 'class': 'INDUSTRY'}, {'name': 'University of Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. David Alter, MD, PhD, FRCPC', 'investigatorFullName': 'Dr. David Alter', 'investigatorAffiliation': 'Toronto Rehabilitation Institute'}}}}