Feasibility of High-Intensity Interval Nordic Walking in Patients With Coronary Artery Disease (HIIT-NoW)
Primary Purpose
Coronary Artery Disease
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High-intensity interval Nordic walking
Standard cardiovascular rehabilitation
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring High-intensity interval training, Nordic walking
Eligibility Criteria
Inclusion Criteria:
- patients with coronary artery disease treated with PCI or CABG;
- willing to come onsite for exercise sessions;
- able to perform a cardiopulmonary exercise testing (CPET); and,
- at least 40 years of age.
Exclusion Criteria:
- currently participating in a CR program;
- unstable angina or established diagnosis of atrial fibrillation, chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy; or,
- unable to return for 10-week follow-up visit.
Sites / Locations
- University of Ottawa Heart InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High-intensity interval Nordic walking
Control
Arm Description
Participants will receive high-intensity interval Nordic walking training.
Participants will undergo standard cardiovascular rehabilitation.
Outcomes
Primary Outcome Measures
Recruitment
Recruitment will be assessed for feasibility. Recruitment will be assessed by the proportion of patients remained interested and randomized after being informed of the requirements of the study
Adherence
Adherence will be assessed for feasibility. Adherence will be assessed by the attendance to the prescribed exercise sessions
Compliance
Compliance will be assessed for feasibility. Compliance will be assessed by the proportion of participants adhering to prescribed exercise intensity. All HIIT-NoW sessions will be monitored by study personnel and compliance to prescribed exercise intensity will be assessed for each exercise session.
Adverse events
Safety will be assessed for feasibility. All mild, moderate, and severe symptoms and adverse events throughout this study will be recorded.
Subjective exercise experiences
Subjective exercise experiences will be assessed for feasibility. Physical activity enjoyment will be collected using the PACES.
Self-efficacy
Self-efficacy will be assessed for feasibility. Exercise self-efficacy will be assessed using the MSES-R.
Secondary Outcome Measures
Cardiorespiratory fitness
Cardiorespiratory fitness (V̇O2peak) will be measured by a symptom-limited CPET.
Functional capacity
Functional capacity will be assessed by the 6-minute walk test.
Fat mass
Fat mass (kg) will be measured using bioelectrical impedance analysis.
Quality of life (QoL)
General Quality of life will be assessed using the Medical Outcomes Study Short Form-36. Higher scores indicate better QoL
Heart Disease specific Quality of life (HeartQoL)
Heart Disease specific Quality of life (HeartQoL) will be assessed using the disease-specific quality of life questionnaire. Higher scores indicate better HeartQoL (0-3 points).
Depression
Depression: will be assessed by the Beck Depression Inventory-II. Higher scores indicate more severe depression symptoms.
Gender
Gender: will be assessed using the Genesis-Praxy questionnaire.
Physical activity levels
Physical activity levels: Participants will wear a activity monitor (Actigraph GT3X) over the right hip for a week at baseline and follow-up.
Subjective functinal capacity
Subjective functional capacity will be assessed by the Duke Activity Status Index questionnaire.
Fat-free mass
Fat-free mass (kg) will be measured using bioelectrical impedance analysis.
Waist circumference
Waist circumference (cm) will be measured by standardized procedures using a Seca tape measure.
Blood pressure
Resting blood pressure will be measured in a seated position after a 5-minute rest period using an automated monitor.
Full Information
NCT ID
NCT05434117
First Posted
June 14, 2022
Last Updated
September 1, 2023
Sponsor
Ottawa Heart Institute Research Corporation
1. Study Identification
Unique Protocol Identification Number
NCT05434117
Brief Title
Feasibility of High-Intensity Interval Nordic Walking in Patients With Coronary Artery Disease
Acronym
HIIT-NoW
Official Title
Feasibility and Preliminary Efficacy of High-intensity Interval Nordic Walking in Patients With Coronary Artery Disease: A Pilot Randomized Clinical Trial (HIIT-NoW)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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
No
5. Study Description
Brief Summary
Coronary revascularization, such as heart bypass surgery (CABG) and percutaneous coronary intervention (PCI [inserting a stent to open up blood vessels]) improve survival for people with coronary artery disease. Yet, many patients suffer from poor physical and mental health after coronary revascularization. Traditional cardiac rehabilitation involving moderate-to-vigorous intensity continuous training (MICT) improves physical and mental health. However, alternative exercise programs, such as high-intensity interval training (HIIT) and Nordic walking may provide superior benefits. Nordic walking is like Nordic skiing but uses specifically designed poles for walking. Nordic walking involved core, upper and lower body muscles, resulting in greater energy expenditure while reducing loading stress at the knee. To date, HIIT used in cardiac rehabilitation settings has focused on lower body (e.g., leg cycling). The investigators are not aware of HIIT protocols that target both upper and lower body at the same time. An exercise program that combines HIIT and Nordic walking (HIIT-NoW) may offer an alternative time-efficient whole-body exercise to improve physical and mental health. This study will test if HIIT-NoW can be an alternative exercise option to improve physical and mental health in patients with coronary artery disease.
Detailed Description
Coronary revascularization improves survival for patients with coronary artery disease (CAD). Despite successful coronary revascularization treatment, however, many patients with CAD are left suffering from poor exercise capacity and frequently experience difficulties in performing daily activities (e.g., getting dressed, sitting down or getting up from the toilet) because of diminished cardiovascular function and exercise tolerance. Decreased exercise capacity leads to a dramatic reduction in quality of life (QoL) and more severe depression symptoms. Low exercise capacity, poor quality of life (QoL) and severer depression symptoms heighten the risk of subsequent cardiovascular events and mortality.
Current guidelines recommend that persons with CAD who have undergone coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) participate in exercise-based cardiovascular rehabilitation (CR). Exercise-based CR is safe, effective and a class IA recommendation following CABG and PCI. Irrefutable evidence demonstrates that exercise-based CR including moderate-to-vigorous intensity continuous exercise training (MICT) improves exercise capacity, QoL, depression and reduces hospital readmissions and cardiovascular morbidity and mortality. MICT has long been used to manage the physical and mental health of CAD patients as per the Canadian Guidelines for Cardiovascular Rehabilitation and Cardiovascular Disease Prevention; however, such exercise may be less efficient and perceived as less motivating/enjoyable. Growing evidence suggests that non-conventional exercise interventions, such as high-intensity interval training (HIIT) and Nordic walking are more effective exercise modalities, and maybe more enjoyable, to improve clinical outcomes (e.g., exercise capacity, QoL, and depression symptoms) in patients with CAD.
HIIT (repeated bouts of brief high-intensity exercise interspersed with active recovery) is an effective and efficient exercise training paradigm. A recent meta-analysis (n=10 studies) comparing HIIT and MICT in patients with CAD suggests that: (1) HIIT is superior to MICT in improving cardiorespiratory fitness (V̇O2peak) of patients with CAD, an important clinical vital sign and strong predictor of mortality; and, (2) HIIT and MICT are equally effective in improving QoL and depression symptoms in patients including CAD. Increases in cardiorespiratory fitness decrease mortality risk -- every 3.5 ml/kg/min increase in V̇O2peak yields a 13% improvement in survival. Exercise training-induced increases in cardiorespiratory fitness are therefore highly desirable for the improvement of important patient outcomes.
Nordic walking is similar to Nordic skiing but uses specifically designed poles for walking. Nordic walking includes the recruitment of core, upper and lower body muscles, resulting in greater exergy expenditure while reducing loading stress at the knee joint. Regular participation in Nordic walking leads to increased exercise capacity. Although data is limited regarding the impact of Nordic walking in comparison to MICT on mental health in patients with CAD, some studies in patients with heart failure have shown superior improvements in QoL and fewer depressive symptoms following Nordic walking when compared to MICT. Our previous randomized controlled trial simultaneously comparing 12 weeks of supervised HIIT, MICT and Nordic walking in patients with CAD showed that Nordic walking was statistically and clinically superior in increasing functional capacity (i.e., distance walked over 6 minutes), and have similar effects on QoL and depression when compared to HIIT or MICT.
As many adults with cardiovascular disease consider lack of time a barrier to exercise, HIIT may be an appealing exercise training paradigm as cardiovascular health benefits can be achieved in less time when compared to MICT. HIIT may also address other frequently reported deterrents to MICT, including lack of interest and motivation, boredom, not challenging enough, and tailored for older people's needs. To date, HIIT used in CR settings has predominantly focused on lower body (e.g., leg cycling). There are few HIIT protocols that simultaneously target both upper and lower body, such as high-intensity interval Nordic walking (HIIT-NoW). Studies have shown that HIIT and Nordic walking are feasible, enjoyable and have similar or superior effects on physical and mental health when compared to MICT. By combining HIIT and Nordic walking, HIIT-NoW may offer an alternative time-efficient whole-body exercise to improve physical and mental health of patients with CAD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
High-intensity interval training, Nordic walking
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel-group pilot RCT
Masking
Outcomes Assessor
Masking Description
Outcome variables will be assessed by study personnel who are blinded to patient allocation.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-intensity interval Nordic walking
Arm Type
Experimental
Arm Description
Participants will receive high-intensity interval Nordic walking training.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants will undergo standard cardiovascular rehabilitation.
Intervention Type
Behavioral
Intervention Name(s)
High-intensity interval Nordic walking
Intervention Description
Participants will complete supervised exercise sessions twice weekly for 10 weeks. Exercise specialists will educate participants in proper use of walking poles and basic Nordic walking techniques and supervise the exercise training sessions. HIIT-NoW will be 45 min in duration using Nordic poles and consists of (i) a 10-min warm-up at 30-59% heart rate reserve (HRR, light-to-moderate intensity); (ii) 4 × 4 min of high-intensity work periods at 60-89% HRR (vigorous intensity) interspersed with 3 min of low-intensity work periods at 30-59% HRR (light-to-moderate intensity); and, (iii) a 10-min cooldown at 30-39% HRR (light intensity). To allow participants to acclimatize to the HIIT-NoW protocol, the training intensity will target 60-69% HRR for the first week, 70-79% HRR in the second week, and 80-89% HRR from the third week onward. If participants do not tolerate 89% HRR well, they will exercise as close to 89% HRR as possible.
Intervention Type
Behavioral
Intervention Name(s)
Standard cardiovascular rehabilitation
Intervention Description
Individuals assigned to standard CR will attend onsite exercise-based CR comprised of one onsite exercise session per week for 8-10 weeks. The onsite CR offers exercise sessions tailored to the fitness of patients and strengthening exercise.
Primary Outcome Measure Information:
Title
Recruitment
Description
Recruitment will be assessed for feasibility. Recruitment will be assessed by the proportion of patients remained interested and randomized after being informed of the requirements of the study
Time Frame
Baseline to week 11 follow up
Title
Adherence
Description
Adherence will be assessed for feasibility. Adherence will be assessed by the attendance to the prescribed exercise sessions
Time Frame
Baseline to week 11 follow up
Title
Compliance
Description
Compliance will be assessed for feasibility. Compliance will be assessed by the proportion of participants adhering to prescribed exercise intensity. All HIIT-NoW sessions will be monitored by study personnel and compliance to prescribed exercise intensity will be assessed for each exercise session.
Time Frame
Baseline to week 11 follow up
Title
Adverse events
Description
Safety will be assessed for feasibility. All mild, moderate, and severe symptoms and adverse events throughout this study will be recorded.
Time Frame
Baseline to week 11 follow up
Title
Subjective exercise experiences
Description
Subjective exercise experiences will be assessed for feasibility. Physical activity enjoyment will be collected using the PACES.
Time Frame
Baseline to week 11 follow up
Title
Self-efficacy
Description
Self-efficacy will be assessed for feasibility. Exercise self-efficacy will be assessed using the MSES-R.
Time Frame
Baseline to week 11 follow up
Secondary Outcome Measure Information:
Title
Cardiorespiratory fitness
Description
Cardiorespiratory fitness (V̇O2peak) will be measured by a symptom-limited CPET.
Time Frame
Baseline to week 11 follow up
Title
Functional capacity
Description
Functional capacity will be assessed by the 6-minute walk test.
Time Frame
Baseline to week 11 follow up
Title
Fat mass
Description
Fat mass (kg) will be measured using bioelectrical impedance analysis.
Time Frame
Baseline to week 11 follow up
Title
Quality of life (QoL)
Description
General Quality of life will be assessed using the Medical Outcomes Study Short Form-36. Higher scores indicate better QoL
Time Frame
Baseline to week 11 follow up
Title
Heart Disease specific Quality of life (HeartQoL)
Description
Heart Disease specific Quality of life (HeartQoL) will be assessed using the disease-specific quality of life questionnaire. Higher scores indicate better HeartQoL (0-3 points).
Time Frame
Baseline to week 11 follow up
Title
Depression
Description
Depression: will be assessed by the Beck Depression Inventory-II. Higher scores indicate more severe depression symptoms.
Time Frame
Baseline to week 11 follow up
Title
Gender
Description
Gender: will be assessed using the Genesis-Praxy questionnaire.
Time Frame
Baseline to week 11 follow up
Title
Physical activity levels
Description
Physical activity levels: Participants will wear a activity monitor (Actigraph GT3X) over the right hip for a week at baseline and follow-up.
Time Frame
Baseline to week 11 follow up
Title
Subjective functinal capacity
Description
Subjective functional capacity will be assessed by the Duke Activity Status Index questionnaire.
Time Frame
Baseline to week 11 follow up
Title
Fat-free mass
Description
Fat-free mass (kg) will be measured using bioelectrical impedance analysis.
Time Frame
Baseline to week 11 follow up
Title
Waist circumference
Description
Waist circumference (cm) will be measured by standardized procedures using a Seca tape measure.
Time Frame
Baseline to week 11 follow up
Title
Blood pressure
Description
Resting blood pressure will be measured in a seated position after a 5-minute rest period using an automated monitor.
Time Frame
Baseline to week 11 follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with coronary artery disease treated with PCI or CABG;
willing to come onsite for exercise sessions;
able to perform a cardiopulmonary exercise testing (CPET); and,
at least 40 years of age.
Exclusion Criteria:
currently participating in a CR program;
unstable angina or established diagnosis of atrial fibrillation, chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy; or,
unable to return for 10-week follow-up visit.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer L Reed, PhD
Phone
613-696-7392
Email
JReed@ottawaheart.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Matheus Mistura, MSc
Phone
613-696-7000
Ext
15944
Email
mistura@ottawaheart.ca
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 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
No
Learn more about this trial
Feasibility of High-Intensity Interval Nordic Walking in Patients With Coronary Artery Disease
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