Coronary Artery DiseaseTalk-TestNCT05157932
An Evaluation of the Talk Test for Exercise Prescription for Home-Based Cardiac Rehabilitation
A study testing Talk test prescription and CPET prescription in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Talk test prescription and CPET prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jul 2022to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Talk Test as an Effective and Safe Approach for Exercise Prescription for Home-Based Cardiac Rehabilitation: A Pilot RCT
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.
Read the detailed description
The Talk Test has been shown to be a valid, practical and inexpensive tool for guiding exercise training in patients with CAD. The general premise of the Talk Test is that exercising at or above the ventilatory threshold or lactate threshold does not allow comfortable, conversational speech and thus serves as a means of estimating the cut point between moderate and vigorous intensity exercise. The Talk Test can be used to produce exercise intensities (64 to 95% HR peak i.e. moderate-to-vigorous intensity exercise) within accepted Canadian Association of Cardiovascular Prevention and Rehabilitation (CACPR) guidelines for exercise training, to avoid exertional ischemia, and has been shown to be consistent across various modes of exercise (i.e. walking, jogging, cycling, elliptical trainer and stair stepper).
There is a critical need to evaluate the effectiveness and safety of using the Talk Test as the principal method of exercise prescription in patients with CAD who have undergone CABG or PCI when compared to standard care CPET. Such a trial has wide-scale appeal for CR programs across Canada and beyond. It will directly and positively impact patient care by reducing the need for in-person interactions for CPET, of paramount importance during COVID-19 outbreaks, between patients and CR staff, thus reducing COVID-19 infection risk and concerns of contracting the virus.
- Conditions
- Coronary Artery Disease
- Being tested
- Talk test prescription, CPET prescription
- Keywords
- Coronary artery disease, Talk test, Cardiopulmonary Exercise test, Cardiac rehabilitation
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talk test prescriptionBehavioural
Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on the Talk test method.
CPET prescriptionBehavioural
Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on their CPET results completed at baseline
| Study group | Role | What they receive |
|---|---|---|
| Talk Test | Experimental | Virtual Cardiac Rehab + Exercise prescription based on the Talk test. Receives: Behavioral: Talk test prescription |
| Cardiopulmonary Exercise Test | Experimental | Virtual Cardiac Rehab + Exercise prescription based on the CPET results. Receives: Behavioral: CPET prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
will be measured by the Incremental Shuttle Walk Test.
Measured: from baseline to follow-up at week 12
Secondary outcomes (7)
Cardiovascular health indicators - Plasma glucose
will be measured by fasting plasma glucose (mmol/L) test
Measured: from baseline to follow-up at week 12
Cardiovascular health indicators - Plasma glucose average
will be measured using the glycated hemoglobin A1C (%) test
Measured: from baseline to follow-up at week 12
Cardiovascular health indicators - Lipid profile
will be measured using the triglycerides test
Measured: from baseline to follow-up at week 12
Cardiovascular health indicators - Cholesterol HDL
will be measured high-density lipoprotein cholesterol.
Measured: from baseline to follow-up at week 12
Cardiovascular health indicators - Cholesterol LDL
will be measured low-density lipoprotein cholesterol.
Measured: from baseline to follow-up at week 12
Cardiac Rehab safety
meticulously track all mild, moderate, and severe symptoms and adverse events throughout this study. Symptoms may include tightness in chest, leg tightness/pain, dizziness, lightheaded, foot cramping, and heart palpitations.
Measured: from baseline to follow-up at week 12
VO2peak
will be measured using a gold standard symptom-limited CPET on an electronically braked cycle ergometer (alternatively it will be administered on a treadmill or another aerobic equipment). Gas exchange (VO2 in mL/kg/min) and heart rate will be monitored continuously. The highest 20-s interval average of VO2 and HR will be considered the peak VO2 and HR values.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start8 Jul 2022
- Primary completion21 May 2026
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Pipe, MD, Study chair, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157932
- Sponsor's protocol ID
- 20210525-01H
- Acronym
- Talk-Test
- Status last verified
- Jun 2026
- First submitted
- 8 Oct 2021
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: it is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Talk Test as an Effective and Safe Approach for Exercise Prescription for Home-Based Cardiac Rehabilitation: A Pilot RCT
- ClinicalTrials.gov ID
- NCT05157932
- Acronym / sponsor ID
- Talk-Test / 20210525-01H
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Talk test, Cardiopulmonary Exercise test, Cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Talk Test has been shown to be a valid, practical and inexpensive tool for guiding exercise training in patients with CAD. The general premise of the Talk Test is that exercising at or above the ventilatory threshold or lactate threshold does not allow comfortable, conversational speech and thus serves as a means of estimating the cut point between moderate and vigorous intensity exercise. The Talk Test can be used to produce exercise intensities (64 to 95% HR peak i.e. moderate-to-vigorous intensity exercise) within accepted Canadian Association of Cardiovascular Prevention and Rehabilitation (CACPR) guidelines for exercise training, to avoid exertional ischemia, and has been shown to be consistent across various modes of exercise (i.e. walking, jogging, cycling, elliptical trainer and stair stepper).
There is a critical need to evaluate the effectiveness and safety of using the Talk Test as the principal method of exercise prescription in patients with CAD who have undergone CABG or PCI when compared to standard care CPET. Such a trial has wide-scale appeal for CR programs across Canada and beyond. It will directly and positively impact patient care by reducing the need for in-person interactions for CPET, of paramount importance during COVID-19 outbreaks, between patients and CR staff, thus reducing COVID-19 infection risk and concerns of contracting the virus.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Talk Test | Experimental | Behavioral: Talk test prescriptionVirtual Cardiac Rehab + Exercise prescription based on the Talk test. |
| Cardiopulmonary Exercise Test | Experimental | Behavioral: CPET prescriptionVirtual Cardiac Rehab + Exercise prescription based on the CPET results. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Talk test prescriptionParticipants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on the Talk test method. | Behavioural | Talk Test |
| CPET prescriptionParticipants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on their CPET results completed at baseline | Behavioural | Cardiopulmonary Exercise Test |
Primary outcome
Exercise capacity
Time frame: from baseline to follow-up at week 12
will be measured by the Incremental Shuttle Walk Test.
7 secondary outcomes
Cardiovascular health indicators - Plasma glucose
Time frame: from baseline to follow-up at week 12
Cardiovascular health indicators - Plasma glucose average
Time frame: from baseline to follow-up at week 12
Cardiovascular health indicators - Lipid profile
Time frame: from baseline to follow-up at week 12
Cardiovascular health indicators - Cholesterol HDL
Time frame: from baseline to follow-up at week 12
Cardiovascular health indicators - Cholesterol LDL
Time frame: from baseline to follow-up at week 12
Cardiac Rehab safety
Time frame: from baseline to follow-up at week 12
VO2peak
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Undecided. it is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Pipe, MD study chair
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Talk test prescription and CPET prescription in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: from baseline to follow-up at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.