Sustaining Physical Activity Following Cardiac Rehabilitation Completion

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

Study Overview

• Status: Completed
• Conditions: Cardiac Rehabilitation
• Intervention / Treatment: Behavioral: Activity Tracker

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Activity Tracker; Participants provided an activity tracker to wear and weekly reports	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.; Other Names: Fitbit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Kelly Evenson, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2017
• Primary Completion (Actual): March 21, 2018
• Study Completion (Actual): March 21, 2018

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: June 26, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 16-3306; UL1TR001111 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Time Frame: Deidentified individual data that supports the activity tracker results may be shared from 0-12 months following publication.

Access Criteria: An investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No