Feasibility of High-Intensity Interval Nordic Walking in Patients With Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05434117
• Other study ID #: 20220260
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2022
• Est. completion date: April 2024

Study information

• Verified date: September 2023
• Source: Ottawa Heart Institute Research Corporation
• Contact: Jennifer L Reed, PhD
• Phone: 613-696-7392
• Email: JReed[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Behavioral:
• High-intensity interval Nordic walking
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.
• Standard cardiovascular rehabilitation
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.

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline to week 11 follow up
Primary	Adherence	Adherence will be assessed for feasibility. Adherence will be assessed by the attendance to the prescribed exercise sessions	Baseline to week 11 follow up
Primary	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.	Baseline to week 11 follow up
Primary	Adverse events	Safety will be assessed for feasibility. All mild, moderate, and severe symptoms and adverse events throughout this study will be recorded.	Baseline to week 11 follow up
Primary	Subjective exercise experiences	Subjective exercise experiences will be assessed for feasibility. Physical activity enjoyment will be collected using the PACES.	Baseline to week 11 follow up
Primary	Self-efficacy	Self-efficacy will be assessed for feasibility. Exercise self-efficacy will be assessed using the MSES-R.	Baseline to week 11 follow up
Secondary	Cardiorespiratory fitness	Cardiorespiratory fitness (V?O2peak) will be measured by a symptom-limited CPET.	Baseline to week 11 follow up
Secondary	Functional capacity	Functional capacity will be assessed by the 6-minute walk test.	Baseline to week 11 follow up
Secondary	Fat mass	Fat mass (kg) will be measured using bioelectrical impedance analysis.	Baseline to week 11 follow up
Secondary	Quality of life (QoL)	General Quality of life will be assessed using the Medical Outcomes Study Short Form-36. Higher scores indicate better QoL	Baseline to week 11 follow up
Secondary	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).	Baseline to week 11 follow up
Secondary	Depression	Depression: will be assessed by the Beck Depression Inventory-II. Higher scores indicate more severe depression symptoms.	Baseline to week 11 follow up
Secondary	Gender	Gender: will be assessed using the Genesis-Praxy questionnaire.	Baseline to week 11 follow up
Secondary	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.	Baseline to week 11 follow up
Secondary	Subjective functinal capacity	Subjective functional capacity will be assessed by the Duke Activity Status Index questionnaire.	Baseline to week 11 follow up
Secondary	Fat-free mass	Fat-free mass (kg) will be measured using bioelectrical impedance analysis.	Baseline to week 11 follow up
Secondary	Waist circumference	Waist circumference (cm) will be measured by standardized procedures using a Seca tape measure.	Baseline to week 11 follow up
Secondary	Blood pressure	Resting blood pressure will be measured in a seated position after a 5-minute rest period using an automated monitor.	Baseline to week 11 follow up