Sedentary Intervention Trial in Cardiac Rehabilitation

NCT ID: NCT02821962

Last Updated: 2019-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-09-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sedentary prompts from a VTAP device

Intervention Type: BEHAVIORAL

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sedentary prompts from a VTAP device

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PAL Technologies Ltd.

OTHER

Sponsor Role: collaborator

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert D Reid, PhD, MBA

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20160336

Identifier Type: -

Identifier Source: org_study_id