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An Evaluation of the Talk Test for Exercise Prescription for Home-Based Cardiac Rehabilitation (Talk-Test)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05157932
Recruitment Status : Recruiting
First Posted : December 15, 2021
Last Update Posted : January 29, 2024
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Behavioral: Talk test prescription Behavioral: CPET prescription Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : February 8, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Talk Test
Virtual Cardiac Rehab + Exercise prescription based on the Talk test.
Behavioral: Talk test prescription
Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on the Talk test method.

Experimental: Cardiopulmonary Exercise Test
Virtual Cardiac Rehab + Exercise prescription based on the CPET results.
Behavioral: CPET prescription
Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on their CPET results completed at baseline




Primary Outcome Measures :
  1. Exercise capacity [ Time Frame: from baseline to follow-up at week 12 ]
    will be measured by the Incremental Shuttle Walk Test.


Secondary Outcome Measures :
  1. Cardiovascular health indicators - Plasma glucose [ Time Frame: from baseline to follow-up at week 12 ]
    will be measured by fasting plasma glucose (mmol/L) test

  2. Cardiovascular health indicators - Plasma glucose average [ Time Frame: from baseline to follow-up at week 12 ]
    will be measured using the glycated hemoglobin A1C (%) test

  3. Cardiovascular health indicators - Lipid profile [ Time Frame: from baseline to follow-up at week 12 ]
    will be measured using the triglycerides test

  4. Cardiovascular health indicators - Cholesterol HDL [ Time Frame: from baseline to follow-up at week 12 ]
    will be measured high-density lipoprotein cholesterol.

  5. Cardiovascular health indicators - Cholesterol LDL [ Time Frame: from baseline to follow-up at week 12 ]
    will be measured low-density lipoprotein cholesterol.

  6. Cardiac Rehab safety [ Time Frame: from baseline to follow-up at week 12 ]
    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.

  7. VO2peak [ Time Frame: at baseline ]
    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.


Other Outcome Measures:
  1. Exercise prescription compliance [ Time Frame: from baseline to follow-up at week 12 ]
    Talk Test group: HR will be measured during exercise training using the Polar A370 device. Following each exercise session, participants will record on a Talk Test log if: (1) singing was possible, (2) comfortable conversation, but not singing was possible, or (3) comfortable conversation was not possible. These responses will be coded as "does not comply", "complies" and "exceeds". CPET group: HR will be measured during exercise training using the Polar A370 device. Where participants exercise below, within or above the prescribed HR ranges (64 to 95% HR peak), they will be coded as "does not comply", "complies" and "exceeds". All participants will wear Polar A370 devices during their exercise training sessions. Exercise HRs will be compared between the Talk Test and CPET groups.

  2. Cardiometabolic health indicators - BMI [ Time Frame: from baseline to follow-up at week 12 ]
    Height (cm) and body mass (kg) will be measured to compute body mass index (kg/m2)

  3. Cardiometabolic health indicators - Body composition [ Time Frame: from baseline to follow-up at week 12 ]
    Body composition will be measured using Fat mass (%) and fat-free mass (%), using bioelectrical impedance analysis.

  4. Cardiometabolic health indicators - Cardiometabolic Risk [ Time Frame: from baseline to follow-up at week 12 ]
    will be measured using waist circumference (cm) and will be measured using standardized procedures.

  5. Cardiometabolic health indicators - Blood pressure [ Time Frame: from baseline to follow-up at week 12 ]
    Resting Systolic (mmHg) and Diastolic (mmHg) blood pressure will be measured in a seated position after a 5-minute rest period on the right arm using an automated, BP monitor (BPTru) that measures 6 times (the first will be discarded and an average of the last 5 measurements will be used for statistical analyses) at 2-minute intervals.

  6. Gender [ Time Frame: from baseline to follow-up at week 12 ]
    gender and its effect will be assessed during cardiac rehabilitation



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05157932


Contacts
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Contact: Jennifer Reed, PhD 6136967392 jreed@ottawaheart.ca
Contact: Matheus Mistura 6136967000 ext 15944 mmistura@ottawaheart.ca

Locations
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Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Contact: Jennifer L Reed, PhD    6136967392 ext 67392    jreed@ottawaheart.ca   
Contact: Matheus Mistura, MSc, BSc    6136967000 ext 15944    mmistura@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Study Chair: Andrew Pipe, MD Ottawa Heart Institute Research Corporation
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Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT05157932    
Other Study ID Numbers: 20210525-01H
First Posted: December 15, 2021    Key Record Dates
Last Update Posted: January 29, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: it is not yet known if there will be a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Heart Institute Research Corporation:
Coronary artery disease
Talk test
Cardiopulmonary Exercise test
Cardiac rehabilitation
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases