An Evaluation of the Talk Test for Exercise Prescription for Home-Based Cardiac Rehabilitation (Talk-Test)
Primary Purpose
Coronary Artery Disease
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Talk test prescription
CPET prescription
Sponsored by
About this trial
This is an interventional other trial for Coronary Artery Disease focused on measuring Coronary artery disease, Talk test, Cardiopulmonary Exercise test, Cardiac rehabilitation
Eligibility 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.
Sites / Locations
- University of Ottawa Heart InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Talk Test
Cardiopulmonary Exercise Test
Arm Description
Virtual Cardiac Rehab + Exercise prescription based on the Talk test.
Virtual Cardiac Rehab + Exercise prescription based on the CPET results.
Outcomes
Primary Outcome Measures
Exercise capacity
will be measured by the Incremental Shuttle Walk Test.
Secondary Outcome Measures
Cardiovascular health indicators - Plasma glucose
will be measured by fasting plasma glucose (mmol/L) test
Cardiovascular health indicators - Plasma glucose average
will be measured using the glycated hemoglobin A1C (%) test
Cardiovascular health indicators - Lipid profile
will be measured using the triglycerides test
Cardiovascular health indicators - Cholesterol HDL
will be measured high-density lipoprotein cholesterol.
Cardiovascular health indicators - Cholesterol LDL
will be measured low-density lipoprotein cholesterol.
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.
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.
Full Information
NCT ID
NCT05157932
First Posted
October 8, 2021
Last Updated
February 27, 2023
Sponsor
Ottawa Heart Institute Research Corporation
1. Study Identification
Unique Protocol Identification Number
NCT05157932
Brief Title
An Evaluation of the Talk Test for Exercise Prescription for Home-Based Cardiac Rehabilitation
Acronym
Talk-Test
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, Talk test, Cardiopulmonary Exercise test, Cardiac rehabilitation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Talk Test
Arm Type
Experimental
Arm Description
Virtual Cardiac Rehab + Exercise prescription based on the Talk test.
Arm Title
Cardiopulmonary Exercise Test
Arm Type
Experimental
Arm Description
Virtual Cardiac Rehab + Exercise prescription based on the CPET results.
Intervention Type
Behavioral
Intervention Name(s)
Talk test prescription
Intervention Description
Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on the Talk test method.
Intervention Type
Behavioral
Intervention Name(s)
CPET prescription
Intervention Description
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 Measure Information:
Title
Exercise capacity
Description
will be measured by the Incremental Shuttle Walk Test.
Time Frame
from baseline to follow-up at week 12
Secondary Outcome Measure Information:
Title
Cardiovascular health indicators - Plasma glucose
Description
will be measured by fasting plasma glucose (mmol/L) test
Time Frame
from baseline to follow-up at week 12
Title
Cardiovascular health indicators - Plasma glucose average
Description
will be measured using the glycated hemoglobin A1C (%) test
Time Frame
from baseline to follow-up at week 12
Title
Cardiovascular health indicators - Lipid profile
Description
will be measured using the triglycerides test
Time Frame
from baseline to follow-up at week 12
Title
Cardiovascular health indicators - Cholesterol HDL
Description
will be measured high-density lipoprotein cholesterol.
Time Frame
from baseline to follow-up at week 12
Title
Cardiovascular health indicators - Cholesterol LDL
Description
will be measured low-density lipoprotein cholesterol.
Time Frame
from baseline to follow-up at week 12
Title
Cardiac Rehab safety
Description
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.
Time Frame
from baseline to follow-up at week 12
Title
VO2peak
Description
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.
Time Frame
at baseline
Other Pre-specified Outcome Measures:
Title
Exercise prescription compliance
Description
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.
Time Frame
from baseline to follow-up at week 12
Title
Cardiometabolic health indicators - BMI
Description
Height (cm) and body mass (kg) will be measured to compute body mass index (kg/m2)
Time Frame
from baseline to follow-up at week 12
Title
Cardiometabolic health indicators - Body composition
Description
Body composition will be measured using Fat mass (%) and fat-free mass (%), using bioelectrical impedance analysis.
Time Frame
from baseline to follow-up at week 12
Title
Cardiometabolic health indicators - Cardiometabolic Risk
Description
will be measured using waist circumference (cm) and will be measured using standardized procedures.
Time Frame
from baseline to follow-up at week 12
Title
Cardiometabolic health indicators - Blood pressure
Description
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.
Time Frame
from baseline to follow-up at week 12
Title
Gender
Description
gender and its effect will be assessed during cardiac rehabilitation
Time Frame
from baseline to follow-up at week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Reed, PhD
Phone
6136967392
Email
jreed@ottawaheart.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Matheus Mistura
Phone
6136967000
Ext
15944
Email
mmistura@ottawaheart.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Pipe, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Study Chair
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4W7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer L Reed, PhD
Phone
6136967392
Ext
67392
Email
jreed@ottawaheart.ca
First Name & Middle Initial & Last Name & Degree
Matheus Mistura, MSc, BSc
Phone
6136967000
Ext
15944
Email
mmistura@ottawaheart.ca
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
it is not yet known if there will be a plan to make IPD available.
Learn more about this trial
An Evaluation of the Talk Test for Exercise Prescription for Home-Based Cardiac Rehabilitation
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