Sedentary Intervention Trial in Cardiac Rehabilitation

Sedentary Intervention Trial in Cardiac Rehabilitation (SIT-CR): A Randomized Controlled Trial Using the activPAL3™ and activPAL3™ VT to Quantify Free-living Movement Patterns and Reducing Sedentary Time in Cardiac Rehabilitation Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02821962

Acronym

SIT-CR

Enrollment

Registered

2016-07-04

Start date

2016-08-31

Completion date

2017-09-30

Last updated

2019-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Sedentary behaviour

Brief summary

Exercise-based cardiac rehabilitation (CR) has been shown to consistently reduce the rates of total and cardiovascular-related mortality and morbidity. Sedentary behaviours have been shown to be high in patients with cardiovascular disease, but it is not yet known if current CR programming results in significant reductions in these behaviours, or whether a targeted component is warranted. It is also unclear if self-reported sedentary time measures can provide valid and reliable information for monitoring these behaviours in a CR setting, or whether more objective measures are needed. The purpose of this study is to assess the feasibility and usability of the activPAL3 devices for measuring sedentary time in a CR setting, describe changes in sedentary time that occur with standard CR and assess whether the addition of prompting cues from a device can result in further declines in sedentary behaviour and improvements in clinical outcomes, health related quality of life, symptoms of anxiety and depression, aortic stiffness, and aerobic capacity.

Interventions

BEHAVIORALSedentary prompts from a VTAP device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient is attending on-site (2 times weekly for 8 weeks) cardiac rehabilitation at the Minto Prevention and Rehabilitation Centre at the University of Ottawa Heart Institute * Patient is 18 years of age or older * Patient has confirmed diagnosis of coronary artery disease (CAD) * Patient understands English or French * Patient is willing and able to provide informed consent

Exclusion criteria

* Patient is unwilling to wear activity monitors * Patient is already using a commercial activity monitor with sedentary prompts (e.g. Jump Up, Garmin) * Patient is unable to attend follow-up visits * Patient not participating in a cardiac rehabilitation program at the University of Ottawa Heart Institute * Patient has cognitive impairment (unable to comprehend or participate in the intervention) * Patient has a history of postural hypotension * Patient is unable, in the opinion of the Medical Director, to participate in the study.

Design outcomes

Primary

Measure	Time frame	Description
Feasibility and Usability of activPAL3 and VTAP Devices	9 weeks	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).

Secondary

Measure	Time frame	Description
Changes in Sedentary Time	baseline and 8 weeks	Changes in sedentary time measured by the activPAL3 over 8-week intervention period. Reported as proportion of day spent sedentary.

Other

Measure	Time frame	Description
Changes in Clinical Body Mass Index	baseline and 8 weeks	Changes in body mass index (kg/m\^2)
Changes in Waist Circumference	baseline and 8 weeks	Changes in waist circumference (cm)
Changes in Systolic Blood Pressure	baseline and 8 weeks	Changes in systolic blood pressure (mmHg)
Changes in Resting Heart Rate	baseline and 8 weeks	Changes in resting heart rate (bpm)
Changes in Total Cholesterol	baseline and 8 weeks	Changes in total cholesterol (mmol/L)
Changes in HbA1c Percentage	baseline and 8 weeks	Changes in HbA1c percentage
Changes in Moderate-to-vigorous Intensity Physical Activity	baseline and 8 weeks	Changes in moderate-to-vigorous intensity physical activity (measured by activPAL3)
Changes in Health-related Quality of Life (Physical Component Scale)	baseline and 8 weeks	Changes in health-related quality of life (Physical Component Scale) as measured by the Short Form-36. Higher scores represent better physical health. Range 0 -100
Changes in Pulse Wave Velocity	baseline and 8 weeks	Changes in pulse wave velocity
Changes in Maximal Aerobic Power (VO2peak)	baseline and 8 weeks	Changes in maximal aerobic power as assessed using a Modified Bruce Ramp Treadmill Test
Change in Health-related Quality of Life (Mental Component Scale)	baseline and 8 weeks	Change in health-related quality of life (Mental Component Scale) from the SF-36. Higher scores represent better mental health. Range 0 to 100.
Changes in HDL	baseline and 8 weeks	Changes in HDL
Changes in Depression Symptoms as Measured by the Hospital Anxiety and Depression Scale.	baseline and 8 weeks	Changes in depression symptom score. Lower scores mean a better outcome. Score ranges from 0 to 21.
Changes in Anxiety	baseline and 8 weeks	Changes in measures of anxiety as assessed using the Hospital Anxiety and Depression Scale. Lower scores mean a better outcome. Score ranges from 0 to 21.
Changes in Body Weight	baseline and 8 weeks	Changes in body weight (kg)

Countries

Canada

Participant flow

Participants by arm

Arm	Count
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	17
Usual Care Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks.	21
Total	38

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	2	0

Baseline characteristics

Characteristic	Sedentary Prompts (VTAP)	Usual Care	Total
Age, Continuous	62.4 years STANDARD_DEVIATION 10.7	61.5 years STANDARD_DEVIATION 9.7	61.9 years STANDARD_DEVIATION 10
Number of cardiac rehabilitation classes attended	14 classes	15 classes	14.5 classes
Race and Ethnicity Not Collected	—	—	0 Participants
Region of Enrollment Canada	17 Participants	21 Participants	38 Participants
Sex: Female, Male Female	7 Participants	8 Participants	15 Participants
Sex: Female, Male Male	10 Participants	13 Participants	23 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 19	0 / 21
other Total, other adverse events	0 / 19	0 / 21
serious Total, serious adverse events	0 / 19	0 / 21

Outcome results

Primary

Feasibility and Usability of activPAL3 and VTAP Devices

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).

Time frame: 9 weeks

Population: Those who completed and returned the satisfaction surveys.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Sedentary Prompts (VTAP)	Feasibility and Usability of activPAL3 and VTAP Devices	14 Participants
Usual Care	Feasibility and Usability of activPAL3 and VTAP Devices	19 Participants

Secondary

Changes in Sedentary Time

Changes in sedentary time measured by the activPAL3 over 8-week intervention period. Reported as proportion of day spent sedentary.