Sedentary Intervention Trial in Cardiac Rehabilitation

Coronary Artery Disease Clinical Trial

— SIT-CR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02821962
• Other study ID #: 20160336
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: September 2017

Study information

• Verified date: July 2019
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Behavioral:
• Sedentary prompts from a VTAP device

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	PAL Technologies Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

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