Trial Outcomes & Findings for Sedentary Intervention Trial in Cardiac Rehabilitation (NCT NCT02821962)

Results Overview

Primary objective is to assess the feasibility and usability of the activPAL3 and VTAP devices in a CR setting. Assessed by examining acceptability of intervention using evaluation surveys (scores). Reporting on number who reported willingness to wear the monitor again (3+). The scale is a 5-point Likert scale that asks "On a scale from 1 to 5, would you be willing to wear the monitor again?". Response options include: 1(never), 2, 3 (maybe), 4, and 5 (yes, please).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

9 weeks

Results posted on

2019-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	Sedentary Prompts (VTAP) Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks. Participants will also be provided with a VTAP (activPAL3 VT) monitor to wear during waking hours for weeks 1 through 7 of cardiac rehabilitation. The VTAP will alert participants when they have been sedentary for 30 consecutive minutes. Sedentary prompts from a VTAP device	Usual Care Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks.
Overall Study STARTED	19	21
Overall Study COMPLETED	17	21
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sedentary Prompts (VTAP) Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks. Participants will also be provided with a VTAP (activPAL3 VT) monitor to wear during waking hours for weeks 1 through 7 of cardiac rehabilitation. The VTAP will alert participants when they have been sedentary for 30 consecutive minutes. Sedentary prompts from a VTAP device	Usual Care Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks.
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sedentary Prompts (VTAP) n=17 Participants Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks. Participants will also be provided with a VTAP (activPAL3 VT) monitor to wear during waking hours for weeks 1 through 7 of cardiac rehabilitation. The VTAP will alert participants when they have been sedentary for 30 consecutive minutes. Sedentary prompts from a VTAP device	Usual Care n=21 Participants Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks.	Total n=38 Participants Total of all reporting groups
Age, Continuous	62.4 years STANDARD_DEVIATION 10.7 • n=17 Participants	61.5 years STANDARD_DEVIATION 9.7 • n=21 Participants	61.9 years STANDARD_DEVIATION 10.0 • n=38 Participants
Sex: Female, Male Female	7 Participants n=17 Participants	8 Participants n=21 Participants	15 Participants n=38 Participants
Sex: Female, Male Male	10 Participants n=17 Participants	13 Participants n=21 Participants	23 Participants n=38 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	17 Participants n=17 Participants	21 Participants n=21 Participants	38 Participants n=38 Participants
Number of cardiac rehabilitation classes attended	14 classes n=17 Participants	15 classes n=21 Participants	14.5 classes n=38 Participants

PRIMARY outcome

Timeframe: 9 weeks

Population: Those who completed and returned the satisfaction surveys.

Primary objective is to assess the feasibility and usability of the activPAL3 and VTAP devices in a CR setting. Assessed by examining acceptability of intervention using evaluation surveys (scores). Reporting on number who reported willingness to wear the monitor again (3+). The scale is a 5-point Likert scale that asks "On a scale from 1 to 5, would you be willing to wear the monitor again?". Response options include: 1(never), 2, 3 (maybe), 4, and 5 (yes, please).