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Trial registered on ANZCTR


Registration number
ACTRN12614000843651
Ethics application status
Approved
Date submitted
30/06/2014
Date registered
7/08/2014
Date last updated
29/10/2018
Date data sharing statement initially provided
29/10/2018
Date results information initially provided
29/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Remote Exercise Monitoring Trial for Exercise-based Cardiac Rehabilitation
Scientific title
Randomised controlled trial to compare the effectiveness of remote monitored exercise-based cardiac rehabilitation with supervised exercise in people with cardiovascular disease to enhance exercise capacity.
Secondary ID [1] 284839 0
3705052
Universal Trial Number (UTN)
Nil
Trial acronym
REMOTE-CR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 292232 0
Condition category
Condition code
Cardiovascular 292568 292568 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 292569 292569 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Consistent with recommendations for supervised home-based exercise, the technology-assisted, home-based, remote monitored exercise cardiac rehabilitation (TexCR) intervention will be delivered over 12 weeks. It will comprise a personalised exercise prescription, telephone support, and behavioural strategies to increase exercise adherence (goal setting, exercise scheduling, overcoming barriers), delivered via smartphone. Participants will be remotely monitored in real-time during bouts of exercise by an exercise physiologist. The intervention aims to have individuals participate in moderate to vigorous aerobic-based exercise for at least 30 minutes (preferably more) most daysof the week, in line with current recommendations and American College of Sports Medicine (ACSM) guidelines. Specific details are provided below.
Exercise prescription: An individualised exercise prescription, based on personal preferences and current exercise capacity, is a core component of the intervention. Following ACSM guidelines for exercise in cardiac patients participants will be provided with a weekly prescription detailing exercise duration, frequency and intensity, via a smartphone application (app). The prescribed exercise intensity will be sufficient to induce a “training effect”, yet below a metabolic load that evokes abnormal clinical signs or symptoms. The preferred mode of exercise will be walking, although participants will be able to choose other modes (e.g. stationary cycling, rowing) if preferred.
During pre-defined time (e.g., 07:00-09:00) windows participants will connect to a remote exercise monitoring system where a remotely-located exercise physiologist will monitor their location, distance, speed, heart rate, respiratory rate, training load and single lead ECG in real-time; provide real-time feedback and support via participants’ smartphones (including alerts, text messages or telephone calls); respond to adverse events if necessary; provide post-exercise feedback; and modify participants’ exercise prescription if needed. Participants can be monitored in any environment with an active broadband connection (mobile, Wi-Fi, Bluetooth) and the system supports simultaneous monitoring of multiple participants.
Support and strategies to facilitate exercise adherence: Behaviour change strategies will be delivered to participants via messages sent through the smartphone. The programme will be grounded in self-efficacy theory, which is the most examined psychological variable within the cardiac setting. Strategies will focus on increasing confidence and motivation to exercise, overcoming barriers to being physically active, scheduling exercise into daily life, goal setting, and enhancing social support and networks to be active. The smartphone app will also allow participants to review their exercise performance and assess progress toward personalised goals.
TexCR System: The system comprises a physiological sensing device, smartphone and web apps, and a middleware platform. The BioHarness 3 (Zephyr Technologies, USA) physiological sensing device enables measurement of a comprehensive range of physiological parameters required for monitoring exercise performance. Bluetooth connectivity permits transmission of data to smartphones. We have developed and pre-tested smartphone (Android) and web apps, incorporating the Odin middleware platform. The smartphone app collects and transmits physiological data to a remotely located web server in real-time. The web app displays these data in remote locations, and enables real-time provision of feedback to moderate participants’ exercise behaviour. The Odin middleware platform, developed by Computer Science at the University of Auckland, is an off-the-shelf solution that provides reliable communication, minimises data usage cost and maximises device battery life.
Intervention code [1] 289635 0
Rehabilitation
Intervention code [2] 289636 0
Behaviour
Intervention code [3] 289889 0
Treatment: Devices
Comparator / control treatment
The active control group will receive a 12 week programme of supervised exercise, delivered at the University of Auckland or Bay of Plenty’s CR clinics. Supervised group-based exercise sessions are offered three times per week by trained exercise scientists/nurses. Participants typically complete a 15-minute warm up, 30-45 minutes of moderate-vigorous intensity aerobic exercise on various exercise modalities (e.g., treadmill, cycle ergometer, rowing machine), and a 5 min cool down. Heart rate, blood pressure, and rating of perceived exertion (RPE) are monitored on a regular basis.
Control group
Active

Outcomes
Primary outcome [1] 292430 0
Change in peak oxygen uptake (VO2 peak) from baseline to 12 weeks assessed during cardiopulmonary exercise test (CPX) on atreadmill
Timepoint [1] 292430 0
12 weeks post randomisation
Secondary outcome [1] 308934 0
Self-efficacy (to complete the programme). Task self-efficacy is assessed using a scale adapted from the Self-Efficacy Scale. Participants rate their confidence to perform physical activities for increasing periods of time (i.e., 10, 30, and 60 min) at three intensities (i.e., light, moderate, and vigorous). A key is provided to define these levels of intensity. Mean scores are calculated with higher values indicating greater efficacy to perform physical activity for longer duration and greater intensity.
Timepoint [1] 308934 0
12 and 24 weeks
Secondary outcome [2] 308942 0
Cardiovascular risk factors; blood pressure, height, weight, waist and hip circumference and blood lipid and glucose concentration.
An electronic sphygmomanometer will be used to assess systolic and diastolic blood pressure pressure.
Participants’ height will be measured to the nearest 0.1 cm using a stadiometer, and body mass to the nearest 0.1 kilograms using electronic scales. Body mass index is derived from the weight (kg) divided by height (m) squared.
A fingertip blood sample is obtained from participants for analysis of blood lipid and glucose concentration using automated point of care analysers (Cholestech LDX or CardioChek).
Timepoint [2] 308942 0
Blood pressure, height, weight, waist and hip circumference (12 and 24 weeks)
Blood lipid and glucose concentration (12 weeks only).
Secondary outcome [3] 308943 0
Health related quality of life (EQ-5D).
Timepoint [3] 308943 0
12 and 24 weeks
Secondary outcome [4] 308944 0
Cost-effectiveness – Cost information will include the cost of each programme, and direct medical costs (including treatment, primary care, secondary care and over-the-counter medications). Healthcare utilisation will be recorded for adverse events including cardiac events, and other events (including, but not limited to, musculoskeletal injury) participants deem likely to be related to their participation in the study.
Timepoint [4] 308944 0
12 and 24 weeks
Secondary outcome [5] 309608 0
Time spent in moderate-to-vigorous intensity physical activity assessed using an Actigraph accelerometer
Timepoint [5] 309608 0
12 and 24 weeks
Secondary outcome [6] 309609 0
Self-reported leisure time exercise assessed using the Godin Leisure Scale Index
Timepoint [6] 309609 0
12 and 24 weeks
Secondary outcome [7] 309610 0
Self-reported intentions to exercise. Intentions to perform physical activity are assessed using two items, which ask participants to rate their level of intention to to follow their exercise prescription during the next 3 months (e.g. " I definitely intend to follow my exercise prescription"). The items are scored using a seven point Likert scale ranging from 0 (completely disagree) to 7 (completely agree). A mean score from the two items is used to give an overall measure of intention.
Timepoint [7] 309610 0
12 and 24 weeks
Secondary outcome [8] 309611 0
Motivation or locus of causality. a reliable and valid three-item self-report measure of the extent to which participants feel they choose to exercise with no sense of coercion. Participants rate how much they agree or disagree with each statement on a seven-item Likert scale from 1 (Strongly disagree) to 7 (Strongly agree) indicating their motivation to perform exercise. Mean scores are calculated and higher scores indicate greater self-determination or a more internal perceived locus of causality
Timepoint [8] 309611 0
12 and 24 weeks

Eligibility
Key inclusion criteria
Aged 18+ years
Have a diagnosis of ischaemic heart disease (angina, myocardial infarction or coronary revascularisation) within the previous three months;
Outpatients who have been clinically stable for at least 6 weeks, are able to perform exercise, understand and write English
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have been admitted to hospital with heart disease within the previous 6 weeks
2. Have terminal cancer
3. Currently exercises for 150 minutes per week at moderate intensity
4. Currently participating in a supervised exercise programme (including exercise-based cardiac rehabilitation)
5. Have significant exercise limitations other than IHD

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible participants will be identified by cardiac rehabilitation nurses from Auckland City Hospital through outpatient clinics and existing databases. We will also recruit via staff at The Cardiac Clinic, Tauranga. We propose recruiting patients that have been discharged from hospital, and are eligible to participate in cardiac rehabilitation (CR). CR nurses or clinic staff will contact potential participants to determine and document their interest in the trial. Interested participants will be screened for eligibility, provided with participant information and consent forms. Interested participants, who agree will be referred to the research team. A research assistant will contact participants to confirm their interest in the study and to schedule a baseline assessment. In addition, we will also recruit participants by contacting existing community-CR education sessions, where the aims of the study will be outlined and people will be invited to take part.

A research assistant will arrange an appointment for the participant to attend the University of Auckland Clinics, or The Cardiac Clinic, Tauranga at an agreed time to undergo assessment. On arrival to the baseline assessment, the researcher will explain procedures and will collect the signed consent forms.

Randomisation will take place after written consent has been obtained and after completion of the baseline assessment.
Participants will be randomized at a 1:1 ratio to receive technology assisted exercise programme (TexCR) or traditional supervised exercise CR, stratified by sex and site. Allocation concealment will be implemented, through the use of Opaque, sealed envelopes at the time of randomisation. Participants will be informed of their group allocation as soon as possible.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A senior biostatistician generated the randomisation sequence. Stratified block randomisation method was used to generate the sequences, with variable block size. Two stratification factors were considered for randomisation: (1) study site (Auckland/Tauranga) and (2) Sex (Female/Male).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Non-inferiority
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The target sample size of 162 participants (81 per group) will provide 80% power at 2.5% level of significance (one-sided) to show that the REMOTE and standard exCR programmes do not differ by more than 1.25 ml/kg/min on peak oxygen uptake. This sample size is based on the assumption the standard exCR programme will result in an increase of 2.4 ml/kg/min (SD 2.7) in peak oxygen uptake at 12 weeks, and has been inflated to allow for 10% loss to follow up. The non-inferiority margin was chosen because it is clinically significant and is associated with lower CV-mortality.

Statistical analyses will be performed using SAS version 9.2 (SAS Institute Inc. Cary NC) and R version 2.11 (R Foundations for Statistical Computing).

Baseline characteristics will be summarised using descriptive statistics. Continuous variables will be described as numbers of observed and missing values, mean, standard deviation, median, minimum and maximum. Categorical variables will be described as frequencies and percentages. Results will be presented for each of the two treatment arms as well as overall.

Treatment evaluation will be performed on the principle of intention to treat (ITT), using data collected from all randomised participants. Analysis of covariance (ANCOVA) regression model will be used to evaluate the main treatment effect on the primary outcome between the two treatment groups, adjusting for its baseline measure, age, ethnicity and other potential confounding factors (if they are statistically significant at 5% level). A similar approach will be used for other continuous secondary outcome measures. Logistic regression model will be considered for the analysis of a binary outcome (e.g. meeting physical activity recommendations).

Cost information will include the cost of each programme and direct medical costs (including cost of treatment, primary care, secondary care and over-the-counter medications). We will use the EQ5D to obtain a single preference index for calculation of Quality Adjusted Life Year (QALY) to assess cost per QALY for comparison with other CR programmes. Healthcare utilisation will be recorded for adverse events including cardiac events, and other events (including, but not limited to, musculoskeletal injury) participants deem likely to be related to their participation in the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6168 0
New Zealand
State/province [1] 6168 0
Auckland
Country [2] 6250 0
New Zealand
State/province [2] 6250 0
Tauranga

Funding & Sponsors
Funding source category [1] 289456 0
Charities/Societies/Foundations
Name [1] 289456 0
Auckland Medical Research Foundation
Address [1] 289456 0
Ground Floor, 89 Grafton Road
P O Box 110139, Auckland Hospital
Auckland 1148
Country [1] 289456 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
School of Population Health
Tamaki Campus
Morrin Rd, Glen Innes, Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 288143 0
University
Name [1] 288143 0
Auckland UniServices Ltd
Address [1] 288143 0
Tamaki Campus
Morrin Rd, Glen Innes, 1142
Auckland
Country [1] 288143 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291214 0
UNIVERSITY OFAUCKLAND HUMAN PARTICIPANTS ETHICS COMMITTEE(UAHPEC)
Ethics committee address [1] 291214 0
The University of Auckland
Private Bag 92019, Victoria Street West
Auckland, 1142
Ethics committee country [1] 291214 0
New Zealand
Date submitted for ethics approval [1] 291214 0
15/11/2013
Approval date [1] 291214 0
06/12/2013
Ethics approval number [1] 291214 0
011021

Summary
Brief summary
Exercise is essential to aid recovery from a heart attack, however adherence to regular exercise is low. In this trial we will compare the effectiveness of home-based monitored exercise using mobile phones and monitoring technology to existing supervised exercise cardiac rehabilitation. 162 participants will be allocated at random to 12 weeks standard supervised exercise cardiac rehabilitation or to the new mobile phone programme. Assessments will compare physical fitness, and change in risk factors associated with heart disease between the two groups. This approach has potential to improve the delivery of cardiac rehabilitation services in New Zealand for those who need it.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49350 0
A/Prof Ralph Maddison
Address 49350 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142
Victoria Street West
Country 49350 0
New Zealand
Phone 49350 0
+6499234767
Fax 49350 0
Email 49350 0
ralph.maddison@deakin.edu.au
Contact person for public queries
Name 49351 0
Mr Jonathan Rawstorn
Address 49351 0
Project Manager
National Institute for Health Innovation, SOPH Tamaki Campus, University of Auckland
Private Bag 92019
Auckland 1142
Victoria Street West

Country 49351 0
New Zealand
Phone 49351 0
+649 9234498
Fax 49351 0
Email 49351 0
jonathan.rawstorn@deakin.edu.au
Contact person for scientific queries
Name 49352 0
A/Prof Ralph Maddison
Address 49352 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142
Victoria Street West
Country 49352 0
New Zealand
Phone 49352 0
+649 9234767
Fax 49352 0
Email 49352 0
ralph.maddison@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 18 0
Maddison R, Rawstorn JC, Stewart RAH, Benatar J, Whittaker R, Rolleston R, Jiang Y, Gao L, Moodie M, Warren I, Meads A, Gant N . Effects and costs of real-time exercise-based telerehabilitation: randomised controlled non-inferiority trial. Heart. 2018, Online First: 27 August 2018. doi:10.1136/heartjnl-2018-313189. PMID: 30150328
Attachments [1] 18 0
Publication date and citation/details [2] 19 0
Rawstorn JC, Gant N, Rolleston A, Whittaker R, Stewart R, Benatar J, Warren I, Meads A, Jiang Y, Maddison R. End-users want alternative intervention delivery models: Usability and acceptability of the REMOTE-CR exercise-based cardiac telerehabilitation programme. Archives of Physical Medicine and Rehabilitation. 2018, 99(11):2373-2377. doi:10.1016/j.apmr.2018.06.027. PMID: 30076800. 02 August 2018.
Attachments [2] 19 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary