Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000312347
Ethics application status
Approved
Date submitted
17/02/2017
Date registered
28/02/2017
Date last updated
25/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the use of personal activity trackers in patients after a heart attack result in an increase in exercise capacity.
Scientific title
The Utility of PerSonal Activity Trackers (Fitbit Charge 2) on Exercise Capacity in Patients Post Acute Coronary Syndrome [UP-STEP ACS Trial]: A Randomised Controlled Trial
Secondary ID [1] 291201 0
None
Universal Trial Number (UTN)
Trial acronym
UP-STEP ACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 302109 0
Obesity 302110 0
Hyperlipidaemia 302111 0
Condition category
Condition code
Cardiovascular 301729 301729 0 0
Coronary heart disease
Metabolic and Endocrine 301769 301769 0 0
Other metabolic disorders
Diet and Nutrition 301770 301770 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the interventional arm will be those who meet the inclusion and exclusion criteria. The interventional involves patients receiving a personal activity tracker (Fitbit Charge 2) prior to hospital discharge. They will be educated regarding its use and will be asked to aim for a minimum of 10,000 steps per day. This will also be synchronized with the Fitbit application on the patients smartphone. Prior to randomisation the patients will undergo physical activity testing in the form of a 6 minute walk test, with distance recorded. In addition other baseline characteristics will be recorded with testing of mood, exercise motivation, quality of life and physical activity levels. Patients will have no further interaction with investigators until the 8 week follow up at which point all tests will be repeated. The patient will be followed up as an outpatient in a clinic to be determined. Adherence to intervention (device worn and steps taken) will be assessed remotely via automatic uploading of the step count to the Fitbit cloud. There will be no interventions to improve fidelity during the study period.
Intervention code [1] 297206 0
Behaviour
Intervention code [2] 297207 0
Rehabilitation
Intervention code [3] 297208 0
Lifestyle
Comparator / control treatment
Patients in the control arm will complete cardiac rehabilitation as per standard of care. This includes either a 4 or 6 week cardiac rehabilitation program incorporating education regarding diet, cardiovascular risk factors and prescription of a tailored exercise program.
Control group
Active

Outcomes
Primary outcome [1] 301135 0
Change in exercise capacity as determined by six minute walk test.
Timepoint [1] 301135 0
Follow up at 8 weeks post hospital discharge.
Secondary outcome [1] 331809 0
1. Change in Cardiac Depression Scale
Timepoint [1] 331809 0
Follow up at 8 weeks post hospital discharge.
Secondary outcome [2] 331917 0
2. Change in International Physical Activity Questionnaire
Timepoint [2] 331917 0
Follow up at 8 weeks post hospital discharge.
Secondary outcome [3] 331918 0
3. Change in Exercise Motivation Index
Timepoint [3] 331918 0
Follow up at 8 weeks post hospital discharge.
Secondary outcome [4] 331919 0
4. Change in SF-36 - QOL
Timepoint [4] 331919 0
Follow up at 8 weeks post hospital discharge.
Secondary outcome [5] 331920 0
5. Change in Weight
Timepoint [5] 331920 0
Follow up at 8 weeks post hospital discharge.
Secondary outcome [6] 331921 0
6. Change in Waist Circumference
Timepoint [6] 331921 0
Follow up at 8 weeks post hospital discharge.
Secondary outcome [7] 331922 0
7. Change in blood glucose levels
Timepoint [7] 331922 0
Follow up at 8 weeks post hospital discharge.
Secondary outcome [8] 331923 0
8. Change in resting blood pressure
Timepoint [8] 331923 0
Follow up at 8 weeks post hospital discharge.
Secondary outcome [9] 331924 0
9. Change in Resting Heart Rate
Timepoint [9] 331924 0
Follow up at 8 weeks post hospital discharge.
Secondary outcome [10] 331925 0
10. Medication compliance - Measure by self-reporting
Timepoint [10] 331925 0
Follow up at 8 weeks post hospital discharge.
Secondary outcome [11] 331928 0
11. Cardiac Rehabilitation compliance - as measured by self reporting
Timepoint [11] 331928 0
Follow up at 8 weeks post hospital discharge.
Secondary outcome [12] 332115 0
12. Change in Blood cholesterol level
Timepoint [12] 332115 0
Follow up at 8 weeks post hospital discharge.

Eligibility
Key inclusion criteria
1. Patient over the age of 18
2. Ability to understand and speak English
3. Ability to understand the study protocol and able to provide informed consent
4. Admitted to hospital and diagnosed with an acute coronary syndrome and have documented coronary artery disease on coronary angiography (coronary artery stenosis >50% in at least one coronary artery) treated either medically or with percutaneous coronary intervention
5. Have low level of physical activity, defined by not meeting recommended weekly exercise targets.
6. Personal ownership of a smartphone able to run the Fitbit application
7. Agreement to complete cardiac rehabilitation program.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability or unwillingness to provide informed consent
2. Significant residual coronary artery disease requiring planned revascularisation
3. Unstable angina
4. Blood pressure >180/110 or symptomatic orthostatic blood pressure decrease >20mmHg
5. Uncontrolled ventricular or atrial arrhythmias
6. Musculoskeletal or medical problems resulting in significant exercise limitation
7. Significant co-existing medical conditions with life expectancy of less than one year
8. New York Heart Association (NYHA) Functional class III-IV
9. Current illicit drug or alcohol use or dependence that in the opinion of the principal investigator would interfere with adherence
10. Clinical signs of cognitive impairment

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer based block stratified randomisation by age, sex.
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
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
The intervention arm (Fitbit) will be compared against the control arm (routine care) on an intention to treat analysis. All statistical analyses will be performed using SPSS v23 (IBM, USA). Baseline characteristics will be summarized using descriptive statistics. Paired Student-t test will be used for all normally distributed continuous variables and will be described as mean with standard deviation. Variables not normally distributed will be analysed using the Wilcoxon Signed Rank test. Categorical variables will be described as frequencies and percentages and will be compared using a chi-squared test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/07/2017
Actual
Date of last participant enrolment
Anticipated
31/01/2019
Actual
Date of last data collection
Anticipated
31/03/2019
Actual
Sample size
Target
200
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8897 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 17143 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 295647 0
Commercial sector/Industry
Name [1] 295647 0
Fitbit Inc
Country [1] 295647 0
Australia
Primary sponsor type
Hospital
Name
MonashHeart, Monash Health
Address
246 Clayton Road
Clayton, Victoria, 3168
Country
Australia
Secondary sponsor category [1] 294498 0
None
Name [1] 294498 0
Address [1] 294498 0
Country [1] 294498 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296965 0
Monash Health HREC
Ethics committee address [1] 296965 0
246 Clayton Road
Clayton, Melbourne, Victoria 3168
Ethics committee country [1] 296965 0
Australia
Date submitted for ethics approval [1] 296965 0
16/02/2017
Approval date [1] 296965 0
21/07/2017
Ethics approval number [1] 296965 0
RES-17-0000094L

Summary
Brief summary
UP-STEP ACS is a prospective single-blinded, two-arm, parallel, randomized control trial with an aim to enrol 200 patients assessing the affect that personal activity monitors have on exercise capacity in patients post acute coronary syndromes primarily measured by a six minute walk test. Secondary end points will be the change in cardiovascular risk factors, namely; blood lipid and glucose levels, weight, waist circumference, medication adherence, mood and quality of life and cardiac rehabilitation adherence. Patients will be randomized to either receive a personal activity tracker or not after initial baseline assessment has been completed while inpatients during their index event. At 8 weeks patients will return for a clinical review and repeat of baseline assessments.
Trial website
Trial related presentations / publications
Public notes
Fitibt Inc will be providing all the study devices as an in-kind donation. Fitbit Inc will have no role in the design, administration or analysis of the study data.

Contacts
Principal investigator
Name 72562 0
A/Prof Arthur Nasis
Address 72562 0
Monash Medical Centre, MonashHeart, Monash Health
246 Clayton Road
Clayton, Melbourne, Victoria 3168
Country 72562 0
Australia
Phone 72562 0
+61 3 9594 6666
Fax 72562 0
Email 72562 0
arthur.nasis@monashhealth.org
Contact person for public queries
Name 72563 0
Jason Nogic
Address 72563 0
Monash Medical Centre, MonashHeart, Monash Health
246 Clayton Road
Clayton, Melbourne, Victoria 3168
Country 72563 0
Australia
Phone 72563 0
+61 3 9594 6666
Fax 72563 0
Email 72563 0
jnogic@gmail.com
Contact person for scientific queries
Name 72564 0
Jason Nogic
Address 72564 0
Monash Medical Centre, MonashHeart, Monash Health
246 Clayton Road
Clayton, Melbourne, Victoria 3168
Country 72564 0
Australia
Phone 72564 0
+61 3 9594 6666
Fax 72564 0
Email 72564 0
jnogic@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe utility of personal activity trackers (Fitbit Charge 2) on exercise capacity in patients post acute coronary syndrome [UP-STEP ACS Trial]: A randomised controlled trial protocol.2017https://dx.doi.org/10.1186/s12872-017-0726-8
EmbaseWearable devices in cardiology.2020
N.B. These documents automatically identified may not have been verified by the study sponsor.