Sedentary Intervention Trial in Cardiac Rehabilitation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Behavioral: Sedentary prompts from a VTAP device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sedentary prompts (VTAP)<br>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. | Behavioral: Sedentary prompts from a VTAP device<br> <br> |
| No Intervention: Usual care<br>Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sedentary behaviour