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OpenTrials
Completed

NCT Number: NCT03991715

Sustaining Physical Activity Following Cardiac Rehabilitation Completion

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

Completed

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Key information

Conditions

Cardiac Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Fitbit

Primary outcomes

  1. Average Steps Per Day (Preintervention Period)

    Time frame: 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 measured by the activity tracker

  2. Average Physical Activity in Minutes Per Day (Preintervention Period)

    Time frame: 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 "very active" minutes per day of physical activity measured by the activity tracker

  3. Average Steps Per Day (Intervention Period)

    Time frame: 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 measured by the activity tracker

  4. Average Physical Activity in Minutes Per Day (Intervention Period)

    Time frame: Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks

    Average "very active" minutes per day of physical activity measured by the activity tracker

  5. Average Steps Per Day (Maintenance Period)

    Time frame: 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 steps per day measured by the activity tracker

  6. Average Physical Activity Per Day (Maintenance Period)

    Time frame: 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

    Average "very active" minutes per day of physical activity measured by the activity tracker

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 19, 2019
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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