Sustaining Physical Activity Following Cardiac Rehabilitation Completion

June 26, 2019 updated by: University of North Carolina, Chapel Hill
Cardiac rehabilitation participants will be enrolled during cardiac rehabilitation and provided an activity tracker to use.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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)
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
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)
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
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)
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
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)
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
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)
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kelly Evenson, PhD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 21, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 21, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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