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Trial registered on ANZCTR


Registration number
ACTRN12613001369718
Ethics application status
Approved
Date submitted
5/12/2013
Date registered
13/12/2013
Date last updated
19/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effects of participant selected music to support the achievement of recommended physical activity levels in older adults following discharge from cardiac rehabilitation.
Scientific title
Investigating the effects of participant selected music to support the achievement of recommended physical activity levels in older adults following discharge from cardiac rehabilitation.
Secondary ID [1] 283703 0
None
Secondary ID [2] 288365 0
No secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac disease 290662 0
Condition category
Condition code
Cardiovascular 291041 291041 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 291079 291079 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
According to usual cardiac rehabilitation protocol, all participants, whether allocated to the experimental group (with participant-selected music) or the control group (with usual care), will receive the National Heart Foundation Guidelines during group presentations and in individual physiotherapy consultations. The guidelines encourage participants to complete at least 30 minutes of moderate physical activity (e.g., walking in 10 minute blocks or more) for five days of each week (150 minutes) with an opportunity to rest on two days if desired. Participants in both groups will be asked to maintain these guidelines following discharge from the cardiac rehabilitation program using walking as a moderate level physical activity. All participants, whether allocated to the music or control group will receive a weekly phone call for the first 6 weeks of the study and then monthly until week 26. The phone calls will ask participants if they have any question or concerns. Participants in both groups will also be asked to maintain an exercise logbook for the first 6 weeks of the study.

Participants allocated to the music intervention (experimental group) will meet with a registered music therapist to select preferred music for walking. Experimental group participants will be able to freely select music that they expect to find physiologically arousing and/or evoke supportive emotions for walking-based exercise. Participants will be encouraged to select as many songs as they wish, potentially several hours of music. Music selection will be assisted by the Brunel Music Rating Inventory-2 (BMRI-2), a 6-item scale with quotients ranging from 6 (low) to 42 (highly motivating) (Karageorghis et al., 2006). Preferred music rated as motivating for walking will be loaded onto lightweight portable music playing devices (MP3 players) for personal use over the 6-month period of the study. Participants will be asked to use the portable music devices when walking. Participants in the experimental group will also be offered an opportunity to review their music at 3-months.

Reference:
Karageorghis CI, Priest DL, Terry PC, Chatzisarantis NL, Lane AM. Redesign and initial validation of an instrument to assess the motivational qualities of music in exercise: The Brunel Music Rating Inventory-2. J Sports Sci 2006; 24: 899-909.
Intervention code [1] 288397 0
Rehabilitation
Comparator / control treatment
Participants in the control group will receive usual care available in the community following discharge from cardiac rehabilitation. Usual care involves access to community exercise groups and centres. Participants in both groups will have received details of community exercise groups and centres during their cardiac rehabilitation.

Control group
Active

Outcomes
Primary outcome [1] 291028 0
The primary outcome will evaluate the proportions of participants in each group meeting the physical activity guidelines at 6 and 26 weeks following discharge from cardiac rehabilitation.

Continuous recording using uni-axial accelerometer-based activity monitors (ActivPAL, PAL Technologies, Glasgow) (Ryan et al., 2006) will calculate number of minutes of moderate intensity physical activity. Moderate level physical activity will be defined by threshold values of walking cadence greater than 60 steps/minute recommended as appropriate for populations with limited mobility (Peiris, Taylor & Shields, 2013), and activity counts greater than 1075 counts per 15 seconds (Ainsworth et al., 2000). The ActivPAL has demonstrated high inter-device reliability for numbers of steps and cadence (ICC (2,1) equal to 0.99) (Ryan et al., 2006), and has been successfully used to document physical activity levels in older adults during inpatient rehabilitation (Peiris, Shields & Taylor, 2012).

References
Ainsworth BE, Haskell WL, Whitt MC, Irwin ML, Swartz AM, Strath SJ et al. Compendium of
Physical Activities: an update of activity codes and MET intensities. Med Sci Sport Exerc 2000; 32: S498-S516.

Peiris CL, Taylor NF, Shields N. Patients receiving inpatient rehabilitation for lower limb orthopaedic conditions do much less physical activity than recommended in guidelines for healthy older adults: an observational study. J of Physiotherapy 2013; 59: 39-44.

Peiris CL, Shields N, Taylor NF. Extra physical therapy and occupational therapy increased physical activity levels in orthopedic rehabilitation: randomized controlled trial. Arch Phys Med Rehabil 2012; 93: e14.

Ryan CG, Grant PM, Tigbe WW, Granat MH. The validity and reliability of a novel activity monitor as a measure of walking. Br J Sports Med 2006; 40: 779-784.
Timepoint [1] 291028 0
Participants in both the experimental and control groups will wear the activity monitors (small light-weight devices attached to the skin) continuously on the front of their thighs for 7-days at discharge (week 0), and weeks 6 and 26 following discharge from the cardiac rehabilitation program.
Secondary outcome [1] 305864 0
A secondary outcome will compare groups to evaluate walking endurance using the 6-minute walk test (6MWT). The test will be performed in a level indoor corridor equal or greater than 20 metres. Ratings of perceived exertion (BORG scale RPE CR 10) (Foster et al., 2001) will be monitored throughout the 6MWT. Distances walked during the 6MWT have demonstrated strong correlation with peak VO2 (r equal to 0.70) in older adults (Miyamoto et al., 2000).

References

Foster C, Florhaug JA, Franklin J, Gottschall L, Horvatin, LA, Parker S et al. A new approach to monitoring exercise testing. J Strength Cond Res 2001; 15: 109-115.

Miyamoto S, Nagaya N, Satoh T, Kyotani S, Sakamaki F, Masatoshi F et al. Clinical correlates and prognostic significance of six-minute walk test in patients with primary pulmonary hypertension: Comparison with cardiopulmonary exercise testing. Am J Crit Care Med 2000; 161: 487-492.
Timepoint [1] 305864 0
A blinded assessor will administer the 6-minute walk test (6MWT) for all participants at discharge (week 0), and weeks 6 and 26 following discharge from the cardiac rehabilitation program.
Secondary outcome [2] 305959 0
A secondary outcome will compare groups to evaluate exercise adherence levels.

Participants from both groups will maintain logbooks for the first 6-weeks recording the date, number of walking sessions, duration and locations of walks, and any events that may have affected participation.
Timepoint [2] 305959 0
Participants from both groups will maintain logbooks for the first 6-weeks.
Secondary outcome [3] 305960 0
A secondary outcome will compare groups to evaluate the incidence of cardiovascular risk factors (elevated blood pressure and body mass indices). Recognized healthy ranges for BMI are 18.5 to 24.9, waist circumference less than 94cm for men and 80cm for women, and blood pressure of 120-systolic/80-diastolic mmHg (Sagiv, 2012).

Reference
Sagiv MS. Exercise Cardiopulmonary Function in Cardiac Patients. London: Springer; 2012.
Timepoint [3] 305960 0
A blinded assessor will measure blood pressure, body mass index (BMI), and waist circumference at weeks 0, 6 and 26.
Secondary outcome [4] 305961 0
A secondary outcome will compare groups to evaluate exercise self-efficacy. Participants will complete three self-efficacy scales measuring task-exercise duration efficacy, task-exercise frequency efficacy, and barrier efficacy at baseline and during weeks 6 and 26 (Blanchard et al., 2002).

References
Blanchard CM, Rodgers WM, Courneya KS, Daub B, Black B. Self-efficacy and mood in cardiac rehabilitation: should gender be considered. Behav Sci 2002; 27: 149-60.
Timepoint [4] 305961 0
Participants will complete the 3 self-efficacy scales at baseline, and during weeks 6 and 26.

Eligibility
Key inclusion criteria
Aged 60 years or older
Able to walk independently
Assessed as a low falls risk
assessed as having intact cognitive functioning
Attended 80% of cardiac rehabilitation sessions
Assessed as having functional hearing
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals less than 60 years of age.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients in the cardiac rehabilitation program receive information about the project from staff, flyers, and during regular presentations. The researcher meets with interested patients and explains the project. Participants are asked to sign informed consent and attend a baseline measurement. Following baseline measurements, participants are allocated to either the intervention or control group using a computer generated concealed method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pr-assigned participant codes are allocated to groups using computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Primary hypothesis. Relative risk ratios are planned to determine if the proportion of participants meeting the recommended guidelines of 150 minutes moderate intensity physical is greater in the music group than the control group during week 6 and week 26 following discharge from the cardiac rehabilitation program.
Secondary hypotheses. Analysis of covariance using baseline measures as co variates is planned to determine whether the secondary outcomes of step count, time spent upright (activity counts), 6MWT distance, blood pressure, BMI, waist circumference and self-efficacy is greater in the music group than the control group at week 6 and week 26 following discharge from the cardiac rehabilitation program. Relative risk ratios are also planned to determine if measures indicating elevated risk factors (blood pressure > 120/80, BMI > 24.9, and waist circumference > 94cm for men and > 80cm for women) are less likely amongst participants from the music group than the control group at week 6 and week 26 following discharge from the cardiac rehabilitation program. Logbooks will be analyzed descriptively for any differences in adherence or adverse events between the groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/02/2014
Actual
21/02/2014
Date of last participant enrolment
Anticipated
28/11/2014
Actual
10/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
53
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 7618 0
3152 - Wantirna
Recruitment postcode(s) [2] 7619 0
3156 - Ferntree Gully
Recruitment postcode(s) [3] 12555 0
3140 - Lilydale

Funding & Sponsors
Funding source category [1] 288385 0
University
Name [1] 288385 0
La Trobe University, Sport Exercise and Rehabilitation Research Focus Area, Grant Scheme 1 - Pilot Project.
Country [1] 288385 0
Australia
Funding source category [2] 288386 0
University
Name [2] 288386 0
University of Melbourne, Faculty Small Grant Scheme (Staff)
Country [2] 288386 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University, Kingsbury Drive, Bundoora, Victoria 3083
Country
Australia
Secondary sponsor category [1] 287086 0
Hospital
Name [1] 287086 0
Eastern Health
Address [1] 287086 0
251 Mountain Highway, Wantirna, 3152, VIC
Country [1] 287086 0
Australia
Secondary sponsor category [2] 287087 0
University
Name [2] 287087 0
Faculty of VCA and MCM, The University of Melbourne
Address [2] 287087 0
The University of Melbourne, Victoria 3010.
Country [2] 287087 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290271 0
Eastern Health Human Research Ethics Committee - Scientific and Ethical Reveiw
Ethics committee address [1] 290271 0
Ethics committee country [1] 290271 0
Australia
Date submitted for ethics approval [1] 290271 0
11/11/2013
Approval date [1] 290271 0
15/11/2013
Ethics approval number [1] 290271 0
E14/1314
Ethics committee name [2] 290272 0
La Trobe University Human Ethics Committee
Ethics committee address [2] 290272 0
Ethics committee country [2] 290272 0
Australia
Date submitted for ethics approval [2] 290272 0
18/11/2013
Approval date [2] 290272 0
04/12/2013
Ethics approval number [2] 290272 0
E14/1314

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44766 0
Prof Nicholas F Taylor
Address 44766 0
Allied Health Research Office, 5 Arnold Street, Box Hill, Victoria 3128
Country 44766 0
Australia
Phone 44766 0
+61 3 9091 8874
Fax 44766 0
Email 44766 0
Nicholas.Taylor@easternhealth.org.au
Contact person for public queries
Name 44767 0
Imogen Clark
Address 44767 0
Music Therapy department - MCM, The University of Melbourne, 151 Barry Street, The University of Melbourne, Victoria 3010.
Country 44767 0
Australia
Phone 44767 0
+61 419 371 960
Fax 44767 0
Email 44767 0
Imogen.Clark@unimelb.edu.au
Contact person for scientific queries
Name 44768 0
Imogen Clark
Address 44768 0
Music Therapy department - MCM, The University of Melbourne, 151 Barry Street, The University of Melbourne, Victoria 3010.
Country 44768 0
Australia
Phone 44768 0
+61 419 371 960
Fax 44768 0
Email 44768 0
Imogen.Clark@unimelb.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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