Cardiac RehabilitationNCT03991715

Sustaining Physical Activity Following Cardiac Rehabilitation Completion

A study testing Activity Tracker in people with Cardiac Rehabilitation, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Cardiac rehabilitation participants will be enrolled during cardiac rehabilitation and provided an activity tracker to use. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiac Rehabilitation
What is being tested?: Activity Tracker
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 13 Nov 2017to 21 Mar 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 14Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

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

Read the 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.

Conditions: Cardiac Rehabilitation
Being tested: Activity Tracker

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03991715
Study group	Role	What they receive
Activity Tracker	Experimental	Participants provided an activity tracker to wear and weekly reports Receives: Behavioral: Activity Tracker

What is being measured

The primary outcome is the main question the study is designed to answer.

Average Steps Per Day (Preintervention Period)
Average steps per day measured by the activity tracker
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 201721 Mar 2018

First posted19 Jun 2019
Study start13 Nov 2017
Primary completion21 Mar 2018
Study completion21 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Model description: This is a pilot study. All participants receive the intervention.
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03991715
Sponsor's protocol ID: 16-3306
Other IDs: UL1TR001111
Status last verified: May 2019
First submitted: 17 Jun 2019
Last updated: 16 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Early Cardiopulmonary Rehabilitation Bundle Functional Capacity and Outcomes of Cardiac Surgeries Patients
Cardiac Surgeries
Not yet recruiting
VWCR to Improve Cardiovascular Health and Outcomes Among Cardiac Patients: A Multicenter Randomized Clinical Trial Protocol (Destination Cardiac Rehab Study)
Heart Diseases
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Recruiting
Resistance Exercise With Blood Flow Restriction by Vascular Occlusion on Myocardial Function in Heart Failure With Reduced Ejection Fraction
Heart Failure, Ventricular Function, Left
Recruiting
Olive Oil Supplementation for Heart Failure With Reduced Ejection Fraction
Heart Failure With Reduced Ejection Fraction (HFrEF)

All Cardiac Rehabilitation trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sustaining Physical Activity Following Cardiac Rehabilitation Completion
ClinicalTrials.gov ID: NCT03991715
Acronym / sponsor ID: 16-3306
Conditions: Cardiac Rehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: 13 Nov 2017 (actual)
Primary completion: 21 Mar 2018 (actual)
Study completion: 21 Mar 2018 (actual)
First posted: 19 Jun 2019 (actual)
Results: Posted 16 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a pilot study. All participants receive the intervention.

Arm	Type	Receives
Activity Tracker	Experimental	Behavioral: Activity TrackerParticipants provided an activity tracker to wear and weekly reports

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Activity TrackerAlso: FitbitIndividually tailored daily and weekly physical activity goals established for all participants. Participants sent weekly reports for 6 weeks after cardiac rehabilitation discharge.	Behavioural	Activity Tracker

Primary outcome

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
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
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
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
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
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

Results and safety

Results posted to the registry on 16 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Activity Tracker	5	5

Primary outcome: 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. Mean (Full Range). Unit: steps per day

Measure	Activity Tracker n = 4
Value	6507 (3523 to 9052)

Population analysed: One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).

Primary outcome: 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. Mean (Full Range). Unit: minutes per day

Measure	Activity Tracker n = 4
Value	14 (2 to 34)

Population analysed: One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).

Primary outcome: 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. Mean (Full Range). Unit: steps per day

Measure	Activity Tracker n = 4
Value	5960 (2828 to 8645)

Population analysed: One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).

Primary outcome: 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. Mean (Full Range). Unit: minutes per day

Measure	Activity Tracker n = 4
Value	11 (2 to 26)

Population analysed: One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).

Adverse events

Time frame: From the time of enrollment (approximately 4 weeks prior to cardiac rehabilitation discharge) through 6 weeks post cardiac rehabilitation discharge.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Activity Tracker	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. 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.

Related trials for Cardiac Rehabilitation

Recruiting
Early Cardiopulmonary Rehabilitation Bundle Functional Capacity and Outcomes of Cardiac Surgeries Patients
Cardiac Surgeries
Not yet recruiting
VWCR to Improve Cardiovascular Health and Outcomes Among Cardiac Patients: A Multicenter Randomized Clinical Trial Protocol (Destination Cardiac Rehab Study)
Heart Diseases
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Recruiting
Resistance Exercise With Blood Flow Restriction by Vascular Occlusion on Myocardial Function in Heart Failure With Reduced Ejection Fraction
Heart Failure, Ventricular Function, Left
Recruiting
Olive Oil Supplementation for Heart Failure With Reduced Ejection Fraction
Heart Failure With Reduced Ejection Fraction (HFrEF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kelly Evenson, PhD principal investigator

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Activity Tracker in people with Cardiac Rehabilitation, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03991715.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.