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Sustaining Physical Activity Following Cardiac Rehabilitation Completion

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ClinicalTrials.gov Identifier: NCT03991715
Recruitment Status : Completed
First Posted : June 19, 2019
Results First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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

Condition or disease Intervention/treatment Phase
Cardiac Rehabilitation Behavioral: Activity Tracker Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a pilot study. All participants receive the intervention.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Sustaining Physical Activity Following Cardiac Rehabilitation Completion
Actual Study Start Date : November 13, 2017
Actual Primary Completion Date : March 21, 2018
Actual Study Completion Date : March 21, 2018

Resource links provided by the National Library of Medicine


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 Name: Fitbit




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03991715


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Kelly Evenson, PhD University of North Carolina, Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03991715     History of Changes
Other Study ID Numbers: 16-3306
UL1TR001111 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2019    Key Record Dates
Results First Posted: July 16, 2019
Last Update Posted: July 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No