Does the use of personal activity trackers in patients after a heart attack result in an increase in exercise capacity.
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
MonashHeart, Monash Health
200 participants
Jul 31, 2017
Interventional
Conditions
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.
Eligibility
Inclusion Criteria7
- Patient over the age of 18
- Ability to understand and speak English
- Ability to understand the study protocol and able to provide informed consent
- 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
- Have low level of physical activity, defined by not meeting recommended weekly exercise targets.
- Personal ownership of a smartphone able to run the Fitbit application
- Agreement to complete cardiac rehabilitation program.
Exclusion Criteria10
- Inability or unwillingness to provide informed consent
- Significant residual coronary artery disease requiring planned revascularisation
- Unstable angina
- Blood pressure >180/110 or symptomatic orthostatic blood pressure decrease >20mmHg
- Uncontrolled ventricular or atrial arrhythmias
- Musculoskeletal or medical problems resulting in significant exercise limitation
- Significant co-existing medical conditions with life expectancy of less than one year
- New York Heart Association (NYHA) Functional class III-IV
- Current illicit drug or alcohol use or dependence that in the opinion of the principal investigator would interfere with adherence
- Clinical signs of cognitive impairment
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Interventions
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.
Locations(1)
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ACTRN12617000312347