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Investigating the Effects of Cardiac Rehabilitation eXercise Modalities on Physical and Mental Health Outcomes (CRX-Modalities)

Primary Purpose

Coronary Artery Disease (CAD)

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High Intensity Interval Training
Moderate Intensity Continuous Exercise Training
Nordic Walking
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronary Artery Disease (CAD) focused on measuring Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with CAD who recently underwent PCI (within 2-10 weeks) PCI or coronary artery bypass grafting (within the last 18 weeks);
  • Patient is referred to University of Ottawa Heart Institute cardiac rehabilitation program;
  • Patient is able to walk independently
  • Patient is willing to attend an onsite cardiac rehabilitation program twice weekly for 12 weeks;
  • At least 40 years of age;
  • Patient is willing and able to provide informed consent

Exclusion Criteria:

  • Currently participating in routine exercise training (>2x/week) and/or using Nordic Walking poles;
  • Active infection or inflammatory condition;
  • Over 75 years of age;
  • Persistent or permanent atrial fibrillation;
  • Pregnant, lactating or planning to become pregnant during the trial period;
  • Unstable angina or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy;
  • Unable to read and understand English or French;
  • Unwilling or unable to return for follow-up visit at weeks 12 and 26;

Sites / Locations

  • University of Ottawa Heart Insititue

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Moderate Intensity Continuous Exercise

Nordic Walking

High Intensity Interval Training

Arm Description

Moderate Intensity Continuous Exercise Training

Nordic Walking

High Intensity Interval Training

Outcomes

Primary Outcome Measures

Exercise Capacity
Changes in exercise capacity from baseline to 12 weeks and baseline to 26 weeks are measured by the six-minute walk test

Secondary Outcome Measures

Functional Fitness
Changes in functional fitness from baseline to 12 weeks and baseline to 26 weeks are measured by the Senior Fitness Test
Aortic stiffness
Changes in aortic stiffness from baseline to 12 weeks and baseline to 26 weeks are measured by pulse wave velocity
Body Composition
Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by the waist circumference.
Body Composition
Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by bioelectrical impedance.
Body Composition
Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by body mass index.
Depression
Changes in depression from baseline to 12 weeks and baseline to 26 weeks are measured by the Beck Depression Inventory-II questionnaire
Quality of Life - SF36
Changes in quality of life from baseline to 12 weeks and baseline to 26 weeks are measured by the Short Form-36.
Quality of Life - HeartQoL
Changes in quality of life from baseline to 12 weeks and baseline to 26 weeks are measured by the HeartQoL questionnaire
Exercise Adherence
Changes in exercise adherence from baseline to 12 weeks and baseline to 26 weeks are measured by the Actigraph accelerometer
Depression mechanisms
Changes in depression mechanisms from baseline to 12 weeks and baseline to 26 weeks are measured by plasma brain derived neurotrophic factor.
Depression mechanisms
Changes in depression mechanisms from baseline to 12 weeks and baseline to 26 weeks are measured by plasma irisin.
Depression mechanisms
Changes in depression mechanisms from baseline to 12 weeks and baseline to 26 weeks are measured by plasma kynurenine.
Lipid and glucose profile
Changes in lipid and glucose profile from baseline to 12 weeks and baseline to 26 weeks are measured by plasma total cholesterol.
Lipid and glucose profile
Changes in lipid and glucose profile from baseline to 12 weeks and baseline to 26 weeks are measured by plasma Low Density Lipoprotein
Lipid and glucose profile
Changes in lipid and glucose profile from baseline to 12 weeks and baseline to 26 weeks are measured by plasma High Density Lipoprotein.
Lipid and glucose profile
Changes in lipid and glucose profile from baseline to 12 weeks and baseline to 26 weeks are measured by plasma Hemoglobin A1c

Full Information

First Posted
April 29, 2016
Last Updated
October 29, 2020
Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Ontario Ministry of Health and Long Term Care, Heart and Stroke Foundation of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02765568
Brief Title
Investigating the Effects of Cardiac Rehabilitation eXercise Modalities on Physical and Mental Health Outcomes
Acronym
CRX-Modalities
Official Title
Investigating the Effects of Cardiac Rehabilitation eXercise Modalities on Physical and Mental Health Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
October 16, 2019 (Actual)
Study Completion Date
October 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Ontario Ministry of Health and Long Term Care, Heart and Stroke Foundation of Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Coronary revascularization improves survival for patients with coronary artery disease. However,many patients are left with poor physical and mental health. Traditional cardiac rehabilitation involves moderate intensity continuous exercise (MICE). Alternatives to traditional cardiac rehabilitation programming may however provide superior understudied benefits to patients with poor physical and mental health. Nordic walking (NW) and high-intensity interval training (HIIT) are two examples of alternative programs for cardiac rehabilitation, which may provide superior physical and mental health benefits when compared to traditional MICE. The main purpose of this project is, therefore, to determine the short and long term physical and mental health benefits of alternative cardiac rehabilitation modalities, including NW and HIIT on exercise capacity, quality of life and depression after a 12-week program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease (CAD)
Keywords
Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate Intensity Continuous Exercise
Arm Type
Experimental
Arm Description
Moderate Intensity Continuous Exercise Training
Arm Title
Nordic Walking
Arm Type
Experimental
Arm Description
Nordic Walking
Arm Title
High Intensity Interval Training
Arm Type
Experimental
Arm Description
High Intensity Interval Training
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Interval Training
Other Intervention Name(s)
HIIT
Intervention Description
Participants will complete supervised exercise sessions. Participants will attend on-site high-intensity interval training two times weekly for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Moderate Intensity Continuous Exercise Training
Other Intervention Name(s)
MICE
Intervention Description
Participants will complete supervised exercise sessions. Moderate-intensity continuous exercise training will follow cardiovascular rehabilitation guidelines. Participants will attend on-site moderate-intensity continuous exercise training two times weekly for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Nordic Walking
Other Intervention Name(s)
NW
Intervention Description
Participants will complete supervised exercise sessions. Participants will attend on-site Nordic walking training two times weekly for 12 weeks
Primary Outcome Measure Information:
Title
Exercise Capacity
Description
Changes in exercise capacity from baseline to 12 weeks and baseline to 26 weeks are measured by the six-minute walk test
Time Frame
Baseline to 12 weeks and Baseline to 26 weeks
Secondary Outcome Measure Information:
Title
Functional Fitness
Description
Changes in functional fitness from baseline to 12 weeks and baseline to 26 weeks are measured by the Senior Fitness Test
Time Frame
Baseline to 12 weeks and Baseline to 26 weeks
Title
Aortic stiffness
Description
Changes in aortic stiffness from baseline to 12 weeks and baseline to 26 weeks are measured by pulse wave velocity
Time Frame
Baseline to 12 weeks and Baseline to 26 weeks
Title
Body Composition
Description
Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by the waist circumference.
Time Frame
Baseline to 12 weeks and Baseline to 26 weeks
Title
Body Composition
Description
Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by bioelectrical impedance.
Time Frame
Baseline to 12 weeks and Baseline to 26 weeks
Title
Body Composition
Description
Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by body mass index.
Time Frame
Baseline to 12 weeks and Baseline to 26 weeks
Title
Depression
Description
Changes in depression from baseline to 12 weeks and baseline to 26 weeks are measured by the Beck Depression Inventory-II questionnaire
Time Frame
Baseline to 12 weeks and Baseline to 26 weeks
Title
Quality of Life - SF36
Description
Changes in quality of life from baseline to 12 weeks and baseline to 26 weeks are measured by the Short Form-36.
Time Frame
Baseline to 12 weeks and Baseline to 26 weeks
Title
Quality of Life - HeartQoL
Description
Changes in quality of life from baseline to 12 weeks and baseline to 26 weeks are measured by the HeartQoL questionnaire
Time Frame
Baseline to 12 weeks and Baseline to 26 weeks
Title
Exercise Adherence
Description
Changes in exercise adherence from baseline to 12 weeks and baseline to 26 weeks are measured by the Actigraph accelerometer
Time Frame
Baseline to 12 weeks and Baseline to 26 weeks
Title
Depression mechanisms
Description
Changes in depression mechanisms from baseline to 12 weeks and baseline to 26 weeks are measured by plasma brain derived neurotrophic factor.
Time Frame
Baseline to 12 weeks and Baseline to 26 weeks
Title
Depression mechanisms
Description
Changes in depression mechanisms from baseline to 12 weeks and baseline to 26 weeks are measured by plasma irisin.
Time Frame
Baseline to 12 weeks and Baseline to 26 weeks
Title
Depression mechanisms
Description
Changes in depression mechanisms from baseline to 12 weeks and baseline to 26 weeks are measured by plasma kynurenine.
Time Frame
Baseline to 12 weeks and Baseline to 26 weeks
Title
Lipid and glucose profile
Description
Changes in lipid and glucose profile from baseline to 12 weeks and baseline to 26 weeks are measured by plasma total cholesterol.
Time Frame
Baseline to 12 weeks and Baseline to 26 weeks
Title
Lipid and glucose profile
Description
Changes in lipid and glucose profile from baseline to 12 weeks and baseline to 26 weeks are measured by plasma Low Density Lipoprotein
Time Frame
Baseline to 12 weeks and Baseline to 26 weeks
Title
Lipid and glucose profile
Description
Changes in lipid and glucose profile from baseline to 12 weeks and baseline to 26 weeks are measured by plasma High Density Lipoprotein.
Time Frame
Baseline to 12 weeks and Baseline to 26 weeks
Title
Lipid and glucose profile
Description
Changes in lipid and glucose profile from baseline to 12 weeks and baseline to 26 weeks are measured by plasma Hemoglobin A1c
Time Frame
Baseline to 12 weeks and Baseline to 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with CAD who recently underwent PCI (within 2-10 weeks) PCI or coronary artery bypass grafting (within the last 18 weeks); Patient is referred to University of Ottawa Heart Institute cardiac rehabilitation program; Patient is able to walk independently Patient is willing to attend an onsite cardiac rehabilitation program twice weekly for 12 weeks; At least 40 years of age; Patient is willing and able to provide informed consent Exclusion Criteria: Currently participating in routine exercise training (>2x/week) and/or using Nordic Walking poles; Active infection or inflammatory condition; Over 75 years of age; Persistent or permanent atrial fibrillation; Pregnant, lactating or planning to become pregnant during the trial period; Unstable angina or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy; Unable to read and understand English or French; Unwilling or unable to return for follow-up visit at weeks 12 and 26;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L Reed, PhD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Insititue
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Investigating the Effects of Cardiac Rehabilitation eXercise Modalities on Physical and Mental Health Outcomes

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