Clinical trial NCT02821962: Sedentary Intervention Trial in Cardiac Rehabilitation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Sedentary behaviour
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: PAL Technologies Ltd.
First posted: 2016-07-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility and Usability of activPAL3 and VTAP Devices
timeFrame: 9 weeks
Secondary outcomes:
measure: Changes in Sedentary Time
timeFrame: baseline and 8 weeks
Other outcomes:
measure: Changes in Moderate-to-vigorous Intensity Physical Activity
timeFrame: baseline and 8 weeks
measure: Changes in Body Weight
timeFrame: baseline and 8 weeks
measure: Changes in Clinical Body Mass Index
timeFrame: baseline and 8 weeks
measure: Changes in Waist Circumference
timeFrame: baseline and 8 weeks
measure: Changes in Systolic Blood Pressure
timeFrame: baseline and 8 weeks
measure: Changes in Resting Heart Rate
timeFrame: baseline and 8 weeks
measure: Changes in Total Cholesterol
timeFrame: baseline and 8 weeks
measure: Changes in HbA1c Percentage
timeFrame: baseline and 8 weeks
measure: Changes in Anxiety
timeFrame: baseline and 8 weeks
measure: Changes in Health-related Quality of Life (Physical Component Scale)
timeFrame: baseline and 8 weeks
measure: Changes in Pulse Wave Velocity
timeFrame: baseline and 8 weeks
measure: Changes in Maximal Aerobic Power (VO2peak)
timeFrame: baseline and 8 weeks
measure: Change in Health-related Quality of Life (Mental Component Scale)
timeFrame: baseline and 8 weeks
measure: Changes in HDL
timeFrame: baseline and 8 weeks
measure: Changes in Depression Symptoms as Measured by the Hospital Anxiety and Depression Scale.
timeFrame: baseline and 8 weeks
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Robert D Reid, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: