Clinical trial NCT03991715: Sustaining Physical Activity Following Cardiac Rehabilitation Completion
Official title: Sustaining Physical Activity Following Cardiac Rehabilitation Completion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Rehabilitation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-06-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a pilot study. All participants receive the intervention.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cardiac rehabilitation participants will be enrolled during cardiac rehabilitation and provided an activity tracker to use.

Detailed description: Cardiac rehabilitation participants will be enrolled during cardiac rehabilitation and provided an activity tracker to use. Each week they will be provided a summary report of their steps and physical activity, that will continue to 6 weeks post discharge from cardiac rehabilitation.

Eligibility criteria: Inclusion criteria:

* coronary heart disease
* currently attending cardiac rehabilitation with at least 4 weeks left
* \>=18 years of age
* own a smart phone and able to participate in mobile health program
* able to understand and write English
* adequate clinical stability
* understand and sign informed consent

Exclusion criteria:

* currently using a digital physical activity tracker
* past use of a digital activity tracker
* planning to relocate in 12 weeks
* acute coronary artery disease symptoms
* decompensated heart failure
* New York Heart Association class IV heart failure
* severe valvular heart disease
* severe pulmonary hypertension
* cardiac transplantation
* visually impaired, severe
* end stage renal disease
* impairment from stroke, injury, or other medical disorder that precludes participation
* dementia that precludes ability to participate and follow protocol
* inability or unwillingness to comply with study requirements

Primary outcomes:
measure: Average Steps Per Day (Preintervention Period)
timeFrame: pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks
measure: Average Physical Activity in Minutes Per Day (Preintervention Period)
timeFrame: pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks
measure: Average Steps Per Day (Intervention Period)
timeFrame: Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks
measure: Average Physical Activity in Minutes Per Day (Intervention Period)
timeFrame: Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks
measure: Average Steps Per Day (Maintenance Period)
timeFrame: Maintenance (day following when the last weekly report was sent to last day of tracking by staff), a total of up to 15 weeks
measure: Average Physical Activity Per Day (Maintenance Period)
timeFrame: Maintenance (day following when the last weekly report was sent to last day of tracking by staff), an overall total of up to 15 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kelly Evenson, PhD
role: PRINCIPAL_INVESTIGATOR
References: