NCT05157932

Brief Summary

The objectives of this pilot RCT are to examine if the Talk Test is an effective and safe tool as compared with CPET for exercise prescription in patients who have undergone CABG or PCI and enrolled in a home-based CR program with virtual exercise training monitoring.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
2mo left

Started Jul 2022

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jul 2022Jul 2026

First Submitted

Initial submission to the registry

October 8, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

July 8, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

4.1 years

First QC Date

October 8, 2021

Last Update Submit

March 11, 2026

Conditions

Coronary Artery Disease

Keywords

Coronary artery diseaseTalk testCardiopulmonary Exercise testCardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Exercise capacity

    will be measured by the Incremental Shuttle Walk Test.

    from baseline to follow-up at week 12

Secondary Outcomes (7)

  • Cardiovascular health indicators - Plasma glucose

    from baseline to follow-up at week 12

  • Cardiovascular health indicators - Plasma glucose average

    from baseline to follow-up at week 12

  • Cardiovascular health indicators - Lipid profile

    from baseline to follow-up at week 12

  • Cardiovascular health indicators - Cholesterol HDL

    from baseline to follow-up at week 12

  • Cardiovascular health indicators - Cholesterol LDL

    from baseline to follow-up at week 12

  • +2 more secondary outcomes

Other Outcomes (6)

  • Exercise prescription compliance

    from baseline to follow-up at week 12

  • Cardiometabolic health indicators - BMI

    from baseline to follow-up at week 12

  • Cardiometabolic health indicators - Body composition

    from baseline to follow-up at week 12

  • +3 more other outcomes

Study Arms (2)

Talk Test

EXPERIMENTAL

Virtual Cardiac Rehab + Exercise prescription based on the Talk test.

Behavioral: Talk test prescription

Cardiopulmonary Exercise Test

EXPERIMENTAL

Virtual Cardiac Rehab + Exercise prescription based on the CPET results.

Behavioral: CPET prescription

Interventions

Talk test prescriptionBEHAVIORAL

Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on the Talk test method.

Talk Test
CPET prescriptionBEHAVIORAL

Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on their CPET results completed at baseline

Cardiopulmonary Exercise Test

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • recently underwent PCI or CABG (at least 4 weeks but less than 12 weeks post-event or procedure);
  • able to perform a CPET;
  • at least 40 years of age;
  • access to MyChart; and,
  • access to email and the internet
  • access to a cellphone with broadband internet (4G, LTE, 5G).

You may not qualify if:

  • currently participating in a virtual or on-site CR program;
  • ventricular ejection fraction ≤45%;
  • unstable angina or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy;
  • unable to return for 12-week follow-up visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Andrew Pipe, MD

    Ottawa Heart Institute Research Corporation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2021

First Posted

December 15, 2021

Study Start

July 8, 2022

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

CA(1)