Sedentary Intervention Trial in Cardiac Rehabilitation (SIT-CR)

July 3, 2019 updated by: Ottawa Heart Institute Research Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Sedentary prompts from a VTAP device
No Intervention: Usual care
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and Usability of activPAL3 and VTAP Devices
Time Frame: 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).
9 weeks

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Collaborators

PAL Technologies Ltd.

Investigators

  • Principal Investigator: Robert D Reid, PhD, MBA, Ottawa Heart Institute Research Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

June 17, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimate)

July 4, 2016

Study Record Updates

Last Update Posted (Actual)

July 17, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160336

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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