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Sedentary Intervention Trial in Cardiac Rehabilitation (SIT-CR)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sedentary prompts from a VTAP device
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring Sedentary behaviour

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sedentary prompts (VTAP)

Usual care

Arm Description

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.

Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
June 17, 2016
Last Updated
July 3, 2019
Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
PAL Technologies Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02821962
Brief Title
Sedentary Intervention Trial in Cardiac Rehabilitation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
PAL Technologies Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Sedentary behaviour

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sedentary prompts (VTAP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants will complete supervised exercise sessions as part of cardiac rehabilitation programming on-site twice weekly for a total of 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Sedentary prompts from a VTAP device
Primary Outcome Measure Information:
Title
Feasibility and Usability of activPAL3 and VTAP Devices
Description
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
Secondary Outcome Measure Information:
Title
Changes in Sedentary Time
Description
Changes in sedentary time measured by the activPAL3 over 8-week intervention period. Reported as proportion of day spent sedentary.
Time Frame
baseline and 8 weeks
Other Pre-specified Outcome Measures:
Title
Changes in Moderate-to-vigorous Intensity Physical Activity
Description
Changes in moderate-to-vigorous intensity physical activity (measured by activPAL3)
Time Frame
baseline and 8 weeks
Title
Changes in Body Weight
Description
Changes in body weight (kg)
Time Frame
baseline and 8 weeks
Title
Changes in Clinical Body Mass Index
Description
Changes in body mass index (kg/m^2)
Time Frame
baseline and 8 weeks
Title
Changes in Waist Circumference
Description
Changes in waist circumference (cm)
Time Frame
baseline and 8 weeks
Title
Changes in Systolic Blood Pressure
Description
Changes in systolic blood pressure (mmHg)
Time Frame
baseline and 8 weeks
Title
Changes in Resting Heart Rate
Description
Changes in resting heart rate (bpm)
Time Frame
baseline and 8 weeks
Title
Changes in Total Cholesterol
Description
Changes in total cholesterol (mmol/L)
Time Frame
baseline and 8 weeks
Title
Changes in HbA1c Percentage
Description
Changes in HbA1c percentage
Time Frame
baseline and 8 weeks
Title
Changes in Anxiety
Description
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.
Time Frame
baseline and 8 weeks
Title
Changes in Health-related Quality of Life (Physical Component Scale)
Description
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
Time Frame
baseline and 8 weeks
Title
Changes in Pulse Wave Velocity
Description
Changes in pulse wave velocity
Time Frame
baseline and 8 weeks
Title
Changes in Maximal Aerobic Power (VO2peak)
Description
Changes in maximal aerobic power as assessed using a Modified Bruce Ramp Treadmill Test
Time Frame
baseline and 8 weeks
Title
Change in Health-related Quality of Life (Mental Component Scale)
Description
Change in health-related quality of life (Mental Component Scale) from the SF-36. Higher scores represent better mental health. Range 0 to 100.
Time Frame
baseline and 8 weeks
Title
Changes in HDL
Description
Changes in HDL
Time Frame
baseline and 8 weeks
Title
Changes in Depression Symptoms as Measured by the Hospital Anxiety and Depression Scale.
Description
Changes in depression symptom score. Lower scores mean a better outcome. Score ranges from 0 to 21.
Time Frame
baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert D Reid, PhD, MBA
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Sedentary Intervention Trial in Cardiac Rehabilitation

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