Evaluating Increasing Physical Activity After Acute Coronary Syndrome

Physical Activity Clinical Trial

Official title:

A Randomized, Controlled Trial Evaluating Methods to Use Physical Activity to Improve Outcomes After Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531022
• Other study ID #: 823025
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: April 3, 2017

Study information

• Verified date: July 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will use a randomized, controlled trial to test the effectiveness of a home-based physical activity program using wearable devices and financial incentives. All participants in will establish a baseline step count during the first two weeks and then proceed to a 16-week intervention period and 8-week follow-up period.

Description:

Cardiovascular disease is the leading cause of mortality in the United States. Among patients that survive an acute myocardial infarction (AMI), cardiac rehabilitation (CR) has been demonstrated to effectively reduce risk of re-infarction, cardiac mortality, and all-cause mortality. However, despite cardiac rehabilitation being a Class I (standard of care) recommendation in multiple American Heart Association acute myocardial infarction guidelines, more than 80% of eligible patients do not receive appropriate cardiac rehabilitation and much of this is due to challenges in access to these programs. Recent innovations in technology allow us to passively monitor an individual's physical activity using wearable devices. Incentives designed using insights from behavioral economics have been demonstrated to motivate device engagement and behavior change. A remotely-monitored cardiac rehabilitation program could improve access for many individuals and potentially be more cost-effective because it is less resource- and personnel-intensive. The objective of this study is to use a randomized, controlled trial to test the effectiveness of a home-based physical activity program using wearable devices and financial incentives.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 3, 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years;

2. ability to read and provide informed consent to participate in the study;

3. History of a) acute coronary syndrome (unstable angina, non-ST segment elevation myocardial infarction or ST segment elevation myocardial infarction); or b) patients having undergone coronary catheterization for suspected coronary artery disease.

Exclusion Criteria:

1. Inability to provide informed consent;

2. does not have daily access to a smartphone compatible with the wearable device;

3. unable or unwilling to complete the baseline 6-minute walk test and return to perform the 6-minute walk test at 10 and 18 weeks;

4. already enrolled in an exercise cardiac rehabilitation program prior to hospital admission;

5. hemodynamic instability or New York Heart Association III-IV heart failure;

6. any other medical conditions that would prohibit participation in an 18-week physical activity program;

7. not being discharged to home if recently admitted.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Physical Activity
• Syndrome

Intervention

Behavioral:
• Financial incentive
A daily financial incentive framed as a loss of $2 each day goal is not acheived
• Daily feedback
Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Daily Steps	The primary outcome variable is the change in mean daily step count from the baseline period to the maintenance period (weeks 9-16).	Baseline and end of Maintenance Period at Week 16
Secondary	Change in Mean Daily Steps From Baseline to Follow-up Period	Secondary outcomes include change in mean daily steps from the baseline period to the follow-up period (weeks 17-24).	Baseline and end of Follow Up Period at week 24