Sustaining Physical Activity Following Cardiac Rehabilitation Completion

Cardiac Rehabilitation Clinical Trial

Official title:

Sustaining Physical Activity Following Cardiac Rehabilitation Completion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03991715
• Other study ID #: 16-3306
• Secondary ID: UL1TR001111
• Status: Completed
• Phase: N/A
• Start date: November 13, 2017
• Est. completion date: March 21, 2018

Study information

• Verified date: May 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 21, 2018
• Est. primary completion date: March 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Rehabilitation

Intervention

Behavioral:
• Activity Tracker
Individually tailored daily and weekly physical activity goals established for all participants. Participants sent weekly reports for 6 weeks after cardiac rehabilitation discharge.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Steps Per Day (Preintervention Period)	Average steps per day measured by the activity tracker	pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks
Primary	Average Physical Activity in Minutes Per Day (Preintervention Period)	Average "very active" minutes per day of physical activity measured by the activity tracker	pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks
Primary	Average Steps Per Day (Intervention Period)	Average steps per day measured by the activity tracker	Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks
Primary	Average Physical Activity in Minutes Per Day (Intervention Period)	Average "very active" minutes per day of physical activity measured by the activity tracker	Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks
Primary	Average Steps Per Day (Maintenance Period)	Average steps per day measured by the activity tracker	Maintenance (day following when the last weekly report was sent to last day of tracking by staff), a total of up to 15 weeks
Primary	Average Physical Activity Per Day (Maintenance Period)	Average "very active" minutes per day of physical activity measured by the activity tracker	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