The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment - II (MAINTAIN-II)
調査の概要
詳細な説明
Physical activity is associated with a 35% decrease in cardiovascular mortality - a direct result of exercise on the vasculature and an indirect result of exercise lowering CVD risk factors such as lipids and blood pressure. With physical inactivity being one of the major independent risk factors for CVD, structured exercise cardiac rehabilitation programs have been implemented to encourage adherence to physical activity among patients with cardiac related issues. Clinical trial evidence has demonstrated irrefutable mortality and morbidity benefits associated with cardiac rehabilitation especially among patients with established CVD. The mechanisms for improved outcomes are likely multifactorial, including improved preventative self-management, physical activity volume, and cardiopulmonary fitness. Unfortunately the real-world outcome benefits associated with cardiac rehabilitation are undermined by behavioural attrition, with programmatic drop out and suboptimal physical activity adherence patterns that mirror the broader healthy population who are not enrolled in cardiac rehabilitation.
Unfortunately the real-world outcome benefits associated with cardiac rehabilitation are undermined by attrition rates of up to 50% post rehabilitation. The goal would therefore be to introduce a co-intervention that encourages long-term exercise adherence for maximal health improvements in cardiac rehabilitation populations, which might also have broader applicability to other non-cardiac rehab populations.
The prior study, The Music Activity INTervention for Adherence Improvement through Neurological entrainment (MAINTAIN -1), examined the use of Tempo Synchronized Playlists (TSP) on improving exercise adherence within the cardiac rehabilitation program. Weekly volumes of physical activity were compared between groups assigned to 3 interventions: control group receiving Usual Care, TSP, and Tempo-pace Synchronized Playlists with Rhythmic Auditory Stimulation (RAS). Rhythmic Auditory Stimulation is a neurological rehabilitation technique used to accentuate tempo-pace synchrony. The group assigned to the TSP intervention demonstrated a significantly higher volume in weekly exercise than the usual care control group. Furthermore, the group randomized to TSP with RAS partook in twice the amount of weekly physical activity than the TSP group without RAS. Our prior study had several limitations including small sample size and an inability to examine the mechanisms by which RAS tempo-based audio-playlist synchronization mediated increases in physical activity.
The objective of this current study is to build on our previous research by examining the reproducibility of efficacy and exploring the mechanisms such as mood, perceived exertion and dissociative attention, by which the preference-based tempo-pace synchronized playlists improve exercise adherence among patients participating in cardiac rehabilitation. Participants will be randomized into 3 Interventions: Usual Care, Audiobooks, and TSP, that will be assigned during months 2 and 3 of the program. The Usual Care group will feature a nested design by which half patients will randomized to receive a silent track during month 2, and the other half will receive white noise. This sequence will be reversed during month 3. Within the TSP intervention, 2 nested designs will be tested. The first will test RAS with non-RAS. Half of the patients will be randomized to receive TSP with RAS during month 2 of the study, while the other half will receive TSP without RAS during month 2. The sequence will be reversed in month 3. The second will determine the effect on training by comparing 'active' vs. 'passive'. Within the active group, participants will be trained on how to exercise with the music. The passive group will not be trained.
Cardiac Rehabilitation provides an ideal test-case program by which to examine music co-interventions, as it mirrors the behavioural attrition experienced in other structured or unstructured exercise activities. Additionally, a music tempo-pace synchronization strategy is appropriate in such a setting as it helps to regulate the exercise pace prescribed to each patient by the program.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Ontario
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Toronto、Ontario、カナダ、M4G 2V6
- Cardiac Rehabilitation and Prevention Program
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients with known cardiovascular disease who are participating in and have been declared medically stable for outpatient cardiac rehabilitation
- Patients must be at least 18 years of age
- Patients must have received at least one exercise prescription that includes consistent walking and/or running (no high interval training or stationary machines)
Exclusion Criteria:
- Participants unable to wear the iPod device or activity monitoring device due to medical or non-medical issues
- Participants with significant communication impairments
- Participants currently enrolled in another intervention study
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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偽コンパレータ:Usual Care
Participants in this intervention will receive the minimal standard of care provided at the Cardiac Rehabilitation and Prevention Program at Toronto Rehabilitation Institute.
Participants will receive an iPod with a silent track or white noise.
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iPods containing either a silent track or white noise
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アクティブコンパレータ:Audiobooks
Participants in this arm will receive iPods with Audiobooks based on their preferred genres.
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iPods with audiobooks
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実験的:Tempo-pace Synchronized Playlists
Participants in this arm will receive audio playlists synchronized to their exercise pace.
Rhythmic enhancements will be added to the playlists during either month 2 or month 3 of the study.
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Playlists with or without RAS
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Average volume of physical activity per week per intervention
時間枠:12 weeks
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The activity monitor will be worn each week for 12 weeks.
Average minutes of physical activity per week will be compared between groups.
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12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Affect measured by Feeling Scale
時間枠:Biweekly for the duration of 12 weeks
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During participant's biweekly exercise session, scores on the Feeling Scale will be recorded per lap.
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Biweekly for the duration of 12 weeks
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Arousal measured by Score on Felt Arousal
時間枠:Biweekly for the duration of 12 weeks
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During participants biweekly exercise session, scores on the Felt Arousal Scale will be recorded per lap
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Biweekly for the duration of 12 weeks
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Perceived Exertion measured by Rate of Perceived Exertion Scale
時間枠:Biweekly for the duration of 12 weeks
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During participants biweekly exercise session, scores on the Rate of Perceived Exertion Scale (RPE) will be recorded per lap.
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Biweekly for the duration of 12 weeks
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Dissociative Attention measured by the Tammen's Scale
時間枠:Biweekly for the duration of 12 weeks
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During participants biweekly exercise session, scores on the Tammen's scale will be recorded per lap.
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Biweekly for the duration of 12 weeks
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Focus measured by the Focus Questionnaire
時間枠:Biweekly for the duration of 12 weeks
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During participants' biweekly exercise session, focus on the audio in the headphones will be recorded at the end of the exercise.
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Biweekly for the duration of 12 weeks
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Pacing of Exercise
時間枠:Biweekly for the duration of 12 weeks
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Number of steps in one minute will be counted during exercise session.
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Biweekly for the duration of 12 weeks
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Lap time
時間枠:Biweekly for the duration of 12 weeks
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Time taken to complete one lap will be recorded for each biweekly exercise session.
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Biweekly for the duration of 12 weeks
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Playcounts
時間枠:8 week duration
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Number of plays of the audio file per week will be recorded
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8 week duration
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Future Hospitalizations and/or Mortality
時間枠:Within 2 years
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Participants will be tracked longitudinally throughout health service encounters including physician visits, hospitalizations, and mortality.
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Within 2 years
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協力者と研究者
捜査官
- 主任研究者:Dr. David Alter, MD,PhD,FRCPC、Toronto Rehabilitation Institute
出版物と役立つリンク
一般刊行物
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- Turk-Adawi KI, Oldridge NB, Tarima SS, Stason WB, Shepard DS. Cardiac rehabilitation patient and organizational factors: what keeps patients in programs? J Am Heart Assoc. 2013 Oct 21;2(5):e000418. doi: 10.1161/JAHA.113.000418.
- Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.
- Goel K, Lennon RJ, Tilbury RT, Squires RW, Thomas RJ. Impact of cardiac rehabilitation on mortality and cardiovascular events after percutaneous coronary intervention in the community. Circulation. 2011 May 31;123(21):2344-52. doi: 10.1161/CIRCULATIONAHA.110.983536. Epub 2011 May 16.
- Davies P, Taylor F, Beswick A, Wise F, Moxham T, Rees K, Ebrahim S. Promoting patient uptake and adherence in cardiac rehabilitation. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD007131. doi: 10.1002/14651858.CD007131.pub2.
- 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. doi: 10.1016/0167-8760(95)00007-f.
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- Alter DA, Zagorski B, Marzolini S, Forhan M, Oh PI. On-site programmatic attendance to cardiac rehabilitation and the healthy-adherer effect. Eur J Prev Cardiol. 2015 Oct;22(10):1232-46. doi: 10.1177/2047487314544084. Epub 2014 Jul 30.
- Brewer, BW., Van Raalte, JL, & Linder, DE. (1996). Attentional Focus and Endurance Performance. Applied Research in Coaching and Athletics Annual. 11:1-14.
- Chen JL, Zatorre RJ, Penhune VB. Interactions between auditory and dorsal premotor cortex during synchronization to musical rhythms. Neuroimage. 2006 Oct 1;32(4):1771-81. doi: 10.1016/j.neuroimage.2006.04.207. Epub 2006 Jun 14.
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- Measuring Enjoyment of Physical Activity in Children: Validation of the Physical Activity Enjoyment Scale. J Appl Sport Psychol. 2009 Jan 1;21(S1):S116-S129. doi: 10.1080/10413200802593612.
- Nakamura PM, Pereira G, Papini CB, Nakamura FY, Kokubun E. Effects of preferred and nonpreferred music on continuous cycling exercise performance. Percept Mot Skills. 2010 Feb;110(1):257-64. doi: 10.2466/PMS.110.1.257-264.
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- Taylor RS, Unal B, Critchley JA, Capewell S. Mortality reductions in patients receiving exercise-based cardiac rehabilitation: how much can be attributed to cardiovascular risk factor improvements? Eur J Cardiovasc Prev Rehabil. 2006 Jun;13(3):369-74. doi: 10.1097/01.hjr.0000199492.00967.11.
- Thompson DR, Bowman GS, Kitson AL, de Bono DP, Hopkins A. Cardiac rehabilitation services in England and Wales: a national survey. Int J Cardiol. 1997 May 23;59(3):299-304. doi: 10.1016/s0167-5273(97)02951-3.
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- Woodcock J, Franco OH, Orsini N, Roberts I. Non-vigorous physical activity and all-cause mortality: systematic review and meta-analysis of cohort studies. Int J Epidemiol. 2011 Feb;40(1):121-38. doi: 10.1093/ije/dyq104. Epub 2010 Jul 14.
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Usual Careの臨床試験
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Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺
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New York UniversitySt. Luke's-Roosevelt Hospital Center完了
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New York UniversityIndiana University; Moi University完了
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Fondation Oeuvre de la Croix Saint-Simon引きこもった
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Boston Medical CenterNational Institute on Minority Health and Health Disparities (NIMHD); Center for Community Health...完了肥満 | 喘息 | 血圧 | 小児発達 | ヘルスケアの利用 | 児童虐待 | 医療格差 | 満たされていない基本的な社会的ニーズアメリカ
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University Health Network, Toronto募集リンパ腫 | リンパ増殖性疾患 | 乳がんステージ I | 乳がんステージ II | 大腸がんステージ II | 結腸直腸がん III期 | 乳がんステージ III | 結腸直腸がんステージ I | 頭頸部がん III期 | 乳がん、ステージ0 | 頭頸部がんステージ I | 頭頸部がんステージ IIカナダ
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Emory UniversityFoundation for Physical Therapy, Inc.完了
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Saint-Joseph University完了