NCT05434117

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

December 9, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

3.3 years

First QC Date

June 14, 2022

Last Update Submit

March 9, 2026

Conditions

Keywords

High-intensity interval trainingNordic walking

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (12)

  • Cardiorespiratory fitness

    Baseline to week 11 follow up

  • Functional capacity

    Baseline to week 11 follow up

  • Fat mass

    Baseline to week 11 follow up

  • Quality of life (QoL)

    Baseline to week 11 follow up

  • Heart Disease specific Quality of life (HeartQoL)

    Baseline to week 11 follow up

  • +7 more secondary outcomes

Study Arms (2)

High-intensity interval Nordic walking

EXPERIMENTAL

Participants will receive high-intensity interval Nordic walking training.

Behavioral: High-intensity interval Nordic walking

Control

ACTIVE COMPARATOR

Participants will undergo standard cardiovascular rehabilitation.

Behavioral: Standard cardiovascular rehabilitation

Interventions

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.

Control

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 Ă— 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.

High-intensity interval Nordic walking

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Jennifer L Reed, PhD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome variables will be assessed by study personnel who are blinded to patient allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel-group pilot RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2022

First Posted

June 27, 2022

Study Start

December 9, 2022

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations