Coronary Artery Disease Clinical Trial
— HIIT-NoWOfficial title:
Feasibility and Preliminary Efficacy of High-intensity Interval Nordic Walking in Patients With Coronary Artery Disease: A Pilot Randomized Clinical Trial (HIIT-NoW)
NCT number | NCT05434117 |
Other study ID # | 20220260 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 9, 2022 |
Est. completion date | April 2024 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Ottawa Heart Institute | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Heart Institute Research Corporation |
Canada,
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 |
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