Trial Outcomes & Findings for Sustaining Physical Activity Following Cardiac Rehabilitation Completion (NCT NCT03991715)

NCT ID: NCT03991715

Last Updated: 2019-07-16

Results Overview

Average steps per day measured by the activity tracker

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks
• Results posted on: 2019-07-16

Participant Flow

Participant milestones

Measure	Activity Tracker 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 Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Activity Tracker n=5 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	61.8 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks

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

Average steps per day measured by the activity tracker

Outcome measures

Measure	Activity Tracker n=4 Participants 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.
Average Steps Per Day (Preintervention Period)	6507 steps per day Interval 3523.0 to 9052.0

PRIMARY outcome

Timeframe: pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks

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

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

Outcome measures

Measure	Activity Tracker n=4 Participants 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.
Average Physical Activity in Minutes Per Day (Preintervention Period)	14 minutes per day Interval 2.0 to 34.0

PRIMARY outcome

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

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

Average steps per day measured by the activity tracker

Outcome measures

Measure	Activity Tracker n=4 Participants 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.
Average Steps Per Day (Intervention Period)	5960 steps per day Interval 2828.0 to 8645.0

PRIMARY outcome

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

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

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

Outcome measures

Measure	Activity Tracker n=4 Participants 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.
Average Physical Activity in Minutes Per Day (Intervention Period)	11 minutes per day Interval 2.0 to 26.0

PRIMARY outcome

Timeframe: Maintenance (day following when the last weekly report was sent to last day of tracking by staff), a total of up to 15 weeks

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

Average steps per day measured by the activity tracker

Outcome measures

Measure	Activity Tracker n=4 Participants 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.
Average Steps Per Day (Maintenance Period)	5158 steps per day Interval 2819.0 to 8852.0

PRIMARY outcome

Timeframe: 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

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

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

Outcome measures

Measure	Activity Tracker n=4 Participants 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.
Average Physical Activity Per Day (Maintenance Period)	7 minutes per day Interval 1.0 to 20.0

Adverse Events

Activity Tracker

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kelly Evenson, PhD

University of North Carolina at Chapel Hill

Phone: (919) 966-1967

Email: kelly_evenson@unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place