Physical Activity Clinical Trial
— MAINTAIN-IIOfficial title:
The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment - II
NCT number | NCT02946060 |
Other study ID # | 15-9839 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2016 |
Est. completion date | August 2017 |
Verified date | April 2020 |
Source | Toronto Rehabilitation Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study (MAINTAIN -II) aims to examine the effect of audio playlists [with or without Rhythmic Auditory Stimulation (RAS)] on the weekly volume of physical activity. Participants will be randomized into 3 Interventions: Control (standard, usual care), Audiobook, or Tempo-pace Synchronized Playlists (TSP). The investigators also aim to explore the effects of these interventions on mood, perceived exertion and dissociative attention among patients participating in cardiac rehabilitation.
Status | Completed |
Enrollment | 169 |
Est. completion date | August 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Cardiac Rehabilitation and Prevention Program | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Toronto Rehabilitation Institute | Heart and Stroke Foundation of Canada |
Canada,
Alter DA, Wijeysundera HC, Franklin B, Austin PC, Chong A, Oh PI, Tu JV, Stukel TA. Obesity, lifestyle risk-factors, and health service outcomes among healthy middle-aged adults in Canada. BMC Health Serv Res. 2012 Aug 4;12:238. doi: 10.1186/1472-6963-12-238. — View Citation
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. — View Citation
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81. — View Citation
Brewer, BW., Van Raalte, JL, & Linder, DE. (1996). Attentional Focus and Endurance Performance. Applied Research in Coaching and Athletics Annual. 11:1-14.
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. — View Citation
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. Epub 2006 Jun 14. — View Citation
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. Review. Update in: Cochrane Database Syst Rev. 2014;6:CD007131. — View Citation
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. — View Citation
Hardy, CJ., & Rejeski, WJ. (1989). Not What, but How One Feels: the Measurement of Affect During Exercise. J. Sport Exerc Psychol. 11:304-317
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. Review. Update in: Cochrane Database Syst Rev. 2016;1:CD001800. — View Citation
Kendzierski D, DeCarlo KJ. Physical Activity Enjoyment Scale: Two validation studies. Journal of Sport & Exercise Psychology. 1991;13(1):50-64.
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. — View Citation
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. — View Citation
Nocon M, Hiemann T, Müller-Riemenschneider F, Thalau F, Roll S, Willich SN. Association of physical activity with all-cause and cardiovascular mortality: a systematic review and meta-analysis. Eur J Cardiovasc Prev Rehabil. 2008 Jun;15(3):239-46. doi: 10.1097/HJR.0b013e3282f55e09. Review. — View Citation
Pinch, TJ., & Bijsterveld, K. (2012). The Oxford Handbook of Sound Studies. New York: Oxford University Press.
Simpson SD, Karageorghis CI. The effects of synchronous music on 400-m sprint performance. J Sports Sci. 2006 Oct;24(10):1095-102. — View Citation
Svebak, S., & Murgatroyd, S. (1985). Metamotivational dominance: A multi-method validation of reversal theory constructs. Journal of Personality and Social Psychology. 48: 107-116.
Tammen, VV. (1996). Elite middle and long distance runner's associative/dissociative coping. J. Apple. Sport Psychol. 8:1-810
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. — View Citation
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. — View Citation
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. — View Citation
WHO. Preventing chronic diseases: A vital investment (2005) [accessed September 20, 2015].http://www .who.int/chp /chronic_disease_report/full_report .pdf.
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. Review. — View Citation
* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average volume of physical activity per week per intervention | The activity monitor will be worn each week for 12 weeks. Average minutes of physical activity per week will be compared between groups. | 12 weeks | |
Secondary | Affect measured by Feeling Scale | During participant's biweekly exercise session, scores on the Feeling Scale will be recorded per lap. | Biweekly for the duration of 12 weeks | |
Secondary | Arousal measured by Score on Felt Arousal | During participants biweekly exercise session, scores on the Felt Arousal Scale will be recorded per lap | Biweekly for the duration of 12 weeks | |
Secondary | Perceived Exertion measured by Rate of Perceived Exertion Scale | During participants biweekly exercise session, scores on the Rate of Perceived Exertion Scale (RPE) will be recorded per lap. | Biweekly for the duration of 12 weeks | |
Secondary | Dissociative Attention measured by the Tammen's Scale | During participants biweekly exercise session, scores on the Tammen's scale will be recorded per lap. | Biweekly for the duration of 12 weeks | |
Secondary | Focus measured by the Focus Questionnaire | During participants' biweekly exercise session, focus on the audio in the headphones will be recorded at the end of the exercise. | Biweekly for the duration of 12 weeks | |
Secondary | Pacing of Exercise | Number of steps in one minute will be counted during exercise session. | Biweekly for the duration of 12 weeks | |
Secondary | Lap time | Time taken to complete one lap will be recorded for each biweekly exercise session. | Biweekly for the duration of 12 weeks | |
Secondary | Playcounts | Number of plays of the audio file per week will be recorded | 8 week duration | |
Secondary | Future Hospitalizations and/or Mortality | Participants will be tracked longitudinally throughout health service encounters including physician visits, hospitalizations, and mortality. | Within 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
Active, not recruiting |
NCT03903874 -
Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt
|
N/A | |
Recruiting |
NCT03662438 -
HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT)
|
N/A | |
Withdrawn |
NCT04540523 -
Home-Based Exergaming Intervention
|
N/A | |
Recruiting |
NCT03250000 -
Changes in Microcirculation and Functional Status During Exacerbation of COPD
|
N/A | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT03430648 -
Is Tau Protein Linked to Mobility Function?
|
||
Completed |
NCT05019482 -
Intervention Program Among University Student to Promote Physical Activity and Reduce the Sedentary Time
|
N/A | |
Completed |
NCT03253406 -
Health Wearables and College Student Health
|
N/A | |
Not yet recruiting |
NCT05985460 -
A Very Brief Intervention to Increase the Intention to Practice Physical Activity
|
N/A | |
Completed |
NCT03700736 -
The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups
|
N/A | |
Completed |
NCT03380143 -
Whole-of-Community Youth Population Physical Activity
|
N/A | |
Completed |
NCT03170921 -
Psychophysiological Characterization of Different Capoeira Performances in Experienced Individuals
|
N/A | |
Completed |
NCT04973813 -
Active Choice Intervention About Physical Activity for Physically Inactive Adults
|
N/A | |
Completed |
NCT03982095 -
Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
|
||
Completed |
NCT03271112 -
Frailty Prevention in Elders From Reunion Island
|
N/A | |
Completed |
NCT05670223 -
Healthy Activities Improve Lives
|
N/A | |
Completed |
NCT04894929 -
Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement
|
N/A | |
Recruiting |
NCT04578067 -
Empowering Immigrant Women for Active and Healthy Lifestyle
|
N/A | |
Completed |
NCT03297567 -
Physical Therapy Guidelines For Hospitalized Elderly
|
N/A |