Sedentary Intervention Trial in Cardiac Rehabilitation

NCT02821962 | Completed Results

• 1 other identifier: 20160336
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Sedentary behaviour

Outcome Measures

Primary Outcomes (1)

• 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).

  9 weeks

Secondary Outcomes (1)

• Changes in Sedentary Time

  baseline and 8 weeks

Other Outcomes (15)

• Changes in Moderate-to-vigorous Intensity Physical Activity

  baseline and 8 weeks

• Changes in Body Weight

  baseline and 8 weeks

• Changes in Clinical Body Mass Index

  baseline and 8 weeks

Study Arms (2)

Sedentary prompts (VTAP)

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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

Interventions

Sedentary prompts from a VTAP device BEHAVIORAL

Sedentary prompts (VTAP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• PAL Technologies Ltd.: collaborator

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr. Robert Reid
• Organization: University of Ottawa Heart Institute

breid@ottawaheart.ca

613-696-7393

Study Officials

• Robert D Reid, PhD, MBA

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: July 4, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 17, 2019
• Results First Posted: June 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)