MedPath

Sedentary Intervention Trial in Cardiac Rehabilitation

Not Applicable
Completed
Conditions
Coronary Artery Disease
Interventions
Behavioral: Sedentary prompts from a VTAP device
Registration Number
NCT02821962
Lead Sponsor
Ottawa Heart Institute Research Corporation
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sedentary prompts (VTAP)Sedentary prompts from a VTAP deviceParticipants 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.
Primary Outcome Measures
NameTimeMethod
Feasibility and Usability of activPAL3 and VTAP Devices9 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).

Secondary Outcome Measures
NameTimeMethod
Changes in Sedentary Timebaseline and 8 weeks

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

Trial Locations

Locations (1)

University of Ottawa Heart Institute

🇨🇦

Ottawa, Ontario, Canada

© Copyright 2025. All Rights Reserved by MedPath