This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Feasibility of High-Intensity Interval Nordic Walking in Patients With Coronary Artery Disease (HIIT-NoW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05434117
Recruitment Status : Recruiting
First Posted : June 27, 2022
Last Update Posted : September 6, 2023
Sponsor:
Information provided by (Responsible Party):
Jennifer Reed, Ottawa Heart Institute Research Corporation

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Behavioral: High-intensity interval Nordic walking Behavioral: Standard cardiovascular rehabilitation Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel-group pilot RCT
Masking: Single (Outcomes Assessor)
Masking Description: Outcome variables will be assessed by study personnel who are blinded to patient allocation.
Primary Purpose: Prevention
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)
Actual Study Start Date : December 9, 2022
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High-intensity interval Nordic walking
Participants will receive high-intensity interval Nordic walking training.
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.

Active Comparator: Control
Participants will undergo standard cardiovascular rehabilitation.
Behavioral: 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.




Primary Outcome Measures :
  1. Recruitment [ Time Frame: Baseline to week 11 follow up ]
    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

  2. Adherence [ Time Frame: Baseline to week 11 follow up ]
    Adherence will be assessed for feasibility. Adherence will be assessed by the attendance to the prescribed exercise sessions

  3. Compliance [ Time Frame: Baseline to week 11 follow up ]
    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.

  4. Adverse events [ Time Frame: Baseline to week 11 follow up ]
    Safety will be assessed for feasibility. All mild, moderate, and severe symptoms and adverse events throughout this study will be recorded.

  5. Subjective exercise experiences [ Time Frame: Baseline to week 11 follow up ]
    Subjective exercise experiences will be assessed for feasibility. Physical activity enjoyment will be collected using the PACES.

  6. Self-efficacy [ Time Frame: Baseline to week 11 follow up ]
    Self-efficacy will be assessed for feasibility. Exercise self-efficacy will be assessed using the MSES-R.


Secondary Outcome Measures :
  1. Cardiorespiratory fitness [ Time Frame: Baseline to week 11 follow up ]
    Cardiorespiratory fitness (V̇O2peak) will be measured by a symptom-limited CPET.

  2. Functional capacity [ Time Frame: Baseline to week 11 follow up ]
    Functional capacity will be assessed by the 6-minute walk test.

  3. Fat mass [ Time Frame: Baseline to week 11 follow up ]
    Fat mass (kg) will be measured using bioelectrical impedance analysis.

  4. Quality of life (QoL) [ Time Frame: Baseline to week 11 follow up ]
    General Quality of life will be assessed using the Medical Outcomes Study Short Form-36. Higher scores indicate better QoL

  5. Heart Disease specific Quality of life (HeartQoL) [ Time Frame: Baseline to week 11 follow up ]
    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).

  6. Depression [ Time Frame: Baseline to week 11 follow up ]
    Depression: will be assessed by the Beck Depression Inventory-II. Higher scores indicate more severe depression symptoms.

  7. Gender [ Time Frame: Baseline to week 11 follow up ]
    Gender: will be assessed using the Genesis-Praxy questionnaire.

  8. Physical activity levels [ Time Frame: Baseline to week 11 follow up ]
    Physical activity levels: Participants will wear a activity monitor (Actigraph GT3X) over the right hip for a week at baseline and follow-up.

  9. Subjective functinal capacity [ Time Frame: Baseline to week 11 follow up ]
    Subjective functional capacity will be assessed by the Duke Activity Status Index questionnaire.

  10. Fat-free mass [ Time Frame: Baseline to week 11 follow up ]
    Fat-free mass (kg) will be measured using bioelectrical impedance analysis.

  11. Waist circumference [ Time Frame: Baseline to week 11 follow up ]
    Waist circumference (cm) will be measured by standardized procedures using a Seca tape measure.

  12. Blood pressure [ Time Frame: Baseline to week 11 follow up ]
    Resting blood pressure will be measured in a seated position after a 5-minute rest period using an automated monitor.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05434117


Contacts
Layout table for location contacts
Contact: Jennifer L Reed, PhD 613-696-7392 JReed@ottawaheart.ca
Contact: Matheus Mistura, MSc 613-696-7000 ext 15944 mistura@ottawaheart.ca

Locations
Layout table for location information
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Contact: Jennifer L Reed, PhD    6136967392 ext 67392    jreed@ottawaheart.ca   
Contact: Matheus Mistura, MSc, BSc    6136967000 ext 15944    mmistura@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
Layout table for investigator information
Principal Investigator: Jennifer L Reed, PhD Ottawa Heart Institute Research Corporation
Layout table for additonal information
Responsible Party: Jennifer Reed, Scientist, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT05434117    
Other Study ID Numbers: 20220260
First Posted: June 27, 2022    Key Record Dates
Last Update Posted: September 6, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Reed, Ottawa Heart Institute Research Corporation:
High-intensity interval training
Nordic walking
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases