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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Cardiac Rehabilitation
Intervention Behavioral: Activity Tracker
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Activity Tracker
Hide Arm/Group Description

Participants provided an activity tracker to wear and weekly reports

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.

Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Activity Tracker
Hide Arm/Group Description

Participants provided an activity tracker to wear and weekly reports

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.

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  60.0%
>=65 years
2
  40.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
61.8
(51 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
1
  20.0%
Male
4
  80.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
 100.0%
1.Primary Outcome
Title Average Steps Per Day (Preintervention Period)
Hide Description Average steps per day measured by the activity tracker
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
Hide Outcome Measure Data
Hide Analysis Population Description
One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).
Arm/Group Title Activity Tracker
Hide Arm/Group Description:

Participants provided an activity tracker to wear and weekly reports

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.

Overall Number of Participants Analyzed 4
Mean (Full Range)
Unit of Measure: steps per day
6507
(3523 to 9052)
2.Primary Outcome
Title Average Physical Activity in Minutes Per Day (Preintervention Period)
Hide Description Average "very active" minutes per day of physical activity measured by the activity tracker
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
Hide Outcome Measure Data
Hide Analysis Population Description
One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).
Arm/Group Title Activity Tracker
Hide Arm/Group Description:

Participants provided an activity tracker to wear and weekly reports

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.

Overall Number of Participants Analyzed 4
Mean (Full Range)
Unit of Measure: minutes per day
14
(2 to 34)
3.Primary Outcome
Title Average Steps Per Day (Intervention Period)
Hide Description Average steps per day measured by the activity tracker
Time Frame Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).
Arm/Group Title Activity Tracker
Hide Arm/Group Description:

Participants provided an activity tracker to wear and weekly reports

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.

Overall Number of Participants Analyzed 4
Mean (Full Range)
Unit of Measure: steps per day
5960
(2828 to 8645)
4.Primary Outcome
Title Average Physical Activity in Minutes Per Day (Intervention Period)
Hide Description Average "very active" minutes per day of physical activity measured by the activity tracker
Time Frame Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).
Arm/Group Title Activity Tracker
Hide Arm/Group Description:

Participants provided an activity tracker to wear and weekly reports

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.

Overall Number of Participants Analyzed 4
Mean (Full Range)
Unit of Measure: minutes per day
11
(2 to 26)
5.Primary Outcome
Title Average Steps Per Day (Maintenance Period)
Hide Description Average steps per day measured by the activity tracker
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
Hide Outcome Measure Data
Hide Analysis Population Description
One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).
Arm/Group Title Activity Tracker
Hide Arm/Group Description:

Participants provided an activity tracker to wear and weekly reports

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.

Overall Number of Participants Analyzed 4
Mean (Full Range)
Unit of Measure: steps per day
5158
(2819 to 8852)
6.Primary Outcome
Title Average Physical Activity Per Day (Maintenance Period)
Hide Description Average "very active" minutes per day of physical activity measured by the activity tracker
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
Hide Outcome Measure Data
Hide Analysis Population Description
One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).
Arm/Group Title Activity Tracker
Hide Arm/Group Description:

Participants provided an activity tracker to wear and weekly reports

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.

Overall Number of Participants Analyzed 4
Mean (Full Range)
Unit of Measure: minutes per day
7
(1 to 20)
Time Frame From the time of enrollment (approximately 4 weeks prior to cardiac rehabilitation discharge) through 6 weeks post cardiac rehabilitation discharge.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Activity Tracker
Hide Arm/Group Description

Participants provided an activity tracker to wear and weekly reports

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.

All-Cause Mortality
Activity Tracker
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Activity Tracker
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Activity Tracker
Affected / at Risk (%)
Total   0/5 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kelly Evenson, PhD
Organization: University of North Carolina at Chapel Hill
Phone: (919) 966-1967
EMail: kelly_evenson@unc.edu
Layout table for additonal information
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 Submitted: June 17, 2019
First Posted: June 19, 2019
Results First Submitted: June 26, 2019
Results First Posted: July 16, 2019
Last Update Posted: July 16, 2019