N/A
Completed N=40
Sedentary Intervention Trial in Cardiac Rehabilitation
Source: ClinicalTrials.gov NCT02821962 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Feasibility and Usability of activPAL3 and VTAP Devices — 14; 19 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility and Usability of activPAL3 and VTAP Devices |
14; 19 | — |
| SECONDARY Changes in Sedentary Time |
-0.2; 1.9 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02821962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.