RecruitingACTRN12617000312347

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

Sponsor

MonashHeart, Monash Health

Enrollment

200 participants

Start Date

Jul 31, 2017

Study Type

Interventional

Conditions

Obesity Acute Coronary Syndrome Hyperlipidaemia

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 90 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving a personal activity tracker (like a Fitbit) to patients who have recently had a heart attack can help them become more physically active. Researchers will measure walking ability, cholesterol, blood sugar, weight, and quality of life at 8 weeks to see if the tracker makes a difference. You may be eligible if: - You are 18 to 90 years of age - You have been admitted to hospital with a heart attack and have confirmed coronary artery disease - You are currently not very physically active (not meeting weekly exercise guidelines) - You own a smartphone that can run the Fitbit app - You agree to complete a cardiac rehabilitation program You may NOT be eligible if: - You have unstable angina or uncontrolled heart rhythm problems - Your blood pressure is very high (above 180/110) - You have significant physical or medical problems that prevent exercise - You have severe heart failure (NYHA Class III or IV) - You have significant cognitive impairment - You have current substance or alcohol dependence Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.