NCT02765568

Brief Summary

Coronary revascularization improves survival for patients with coronary artery disease. However,many patients are left with poor physical and mental health. Traditional cardiac rehabilitation involves moderate intensity continuous exercise (MICE). Alternatives to traditional cardiac rehabilitation programming may however provide superior understudied benefits to patients with poor physical and mental health. Nordic walking (NW) and high-intensity interval training (HIIT) are two examples of alternative programs for cardiac rehabilitation, which may provide superior physical and mental health benefits when compared to traditional MICE. The main purpose of this project is, therefore, to determine the short and long term physical and mental health benefits of alternative cardiac rehabilitation modalities, including NW and HIIT on exercise capacity, quality of life and depression after a 12-week program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 29, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2019

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

3.4 years

First QC Date

April 29, 2016

Last Update Submit

October 29, 2020

Conditions

Keywords

Coronary Artery DiseasePercutaneous Coronary Intervention (PCI)

Outcome Measures

Primary Outcomes (1)

  • Exercise Capacity

    Changes in exercise capacity from baseline to 12 weeks and baseline to 26 weeks are measured by the six-minute walk test

    Baseline to 12 weeks and Baseline to 26 weeks

Secondary Outcomes (16)

  • Functional Fitness

    Baseline to 12 weeks and Baseline to 26 weeks

  • Aortic stiffness

    Baseline to 12 weeks and Baseline to 26 weeks

  • Body Composition

    Baseline to 12 weeks and Baseline to 26 weeks

  • Body Composition

    Baseline to 12 weeks and Baseline to 26 weeks

  • Body Composition

    Baseline to 12 weeks and Baseline to 26 weeks

  • +11 more secondary outcomes

Study Arms (3)

Moderate Intensity Continuous Exercise

EXPERIMENTAL

Moderate Intensity Continuous Exercise Training

Behavioral: Moderate Intensity Continuous Exercise Training

Nordic Walking

EXPERIMENTAL

Nordic Walking

Behavioral: Nordic Walking

High Intensity Interval Training

EXPERIMENTAL

High Intensity Interval Training

Behavioral: High Intensity Interval Training

Interventions

Participants will complete supervised exercise sessions. Participants will attend on-site high-intensity interval training two times weekly for 12 weeks

Also known as: HIIT
High Intensity Interval Training

Participants will complete supervised exercise sessions. Moderate-intensity continuous exercise training will follow cardiovascular rehabilitation guidelines. Participants will attend on-site moderate-intensity continuous exercise training two times weekly for 12 weeks.

Also known as: MICE
Moderate Intensity Continuous Exercise
Nordic WalkingBEHAVIORAL

Participants will complete supervised exercise sessions. Participants will attend on-site Nordic walking training two times weekly for 12 weeks

Also known as: NW
Nordic Walking

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with CAD who recently underwent PCI (within 2-10 weeks) PCI or coronary artery bypass grafting (within the last 18 weeks);
  • Patient is referred to University of Ottawa Heart Institute cardiac rehabilitation program;
  • Patient is able to walk independently
  • Patient is willing to attend an onsite cardiac rehabilitation program twice weekly for 12 weeks;
  • At least 40 years of age;
  • Patient is willing and able to provide informed consent

You may not qualify if:

  • Currently participating in routine exercise training (\>2x/week) and/or using Nordic Walking poles;
  • Active infection or inflammatory condition;
  • Over 75 years of age;
  • Persistent or permanent atrial fibrillation;
  • Pregnant, lactating or planning to become pregnant during the trial period;
  • Unstable angina or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy;
  • Unable to read and understand English or French;
  • Unwilling or unable to return for follow-up visit at weeks 12 and 26;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Insititue

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (2)

  • Marcal IR, Cotie LM, Ribeiro I, Reed JL. The Effects of Different Exercise Modalities and Intensities on Arterial Stiffness in Patients With Coronary Artery Disease. J Cardiopulm Rehabil Prev. 2023 Sep 1;43(5):384-385. doi: 10.1097/HCR.0000000000000799. Epub 2023 May 15. No abstract available.

  • Garneau L, Terada T, Mistura M, Mulvihill EE, Reed JL, Aguer C. Exercise training reduces circulating cytokines in male patients with coronary artery disease and type 2 diabetes: A pilot study. Physiol Rep. 2023 Mar;11(5):e15634. doi: 10.14814/phy2.15634.

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

High-Intensity Interval TrainingNordic Walking

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaWalkingLocomotion

Study Officials

  • Jennifer L Reed, PhD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2016

First Posted

May 6, 2016

Study Start

June 1, 2016

Primary Completion

October 16, 2019

Study Completion

October 16, 2019

Last Updated

October 30, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations