Sustaining Physical Activity Following Cardiac Rehabilitation Completion

NCT03991715 | Completed Results

• 2 other identifiers: 16-3306UL1TR001111
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Activity Tracker

EXPERIMENTAL

Participants provided an activity tracker to wear and weekly reports

Behavioral: Activity Tracker

Interventions

Activity Tracker BEHAVIORAL

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

Also known as: Fitbit

Activity Tracker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Interventions

Fitness Trackers

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Results Point of Contact

• Title: Kelly Evenson, PhD
• Organization: University of North Carolina at Chapel Hill

kelly_evenson@unc.edu

(919) 966-1967

Study Officials

• Kelly Evenson, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot study. All participants receive the intervention.

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 19, 2019
• Study Start: November 13, 2017
• Primary Completion: March 21, 2018
• Study Completion: March 21, 2018
• Last Updated: July 16, 2019
• Results First Posted: July 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)