Exercise Training for Cardiovascular Disease

(CIED-EX Trial)

Overseen By Isabela Marcal, MSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Unstable angina, COPD, severe stenosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Cardiac implantable electronic devices (CIED) are established treatments for a variety of cardiac arrhythmias. Women with CIED have lower fitness and lower quality of life compared to men with CIED. Moderate-intensity continuous training (MICT) is the most prescribed exercise for women. However, high-intensity interval training (HIIT) has been shown to improve fitness, anxiety levels, quality of life, and other health indicators over MICT in men with CIED. There is a need to quantitatively evaluate the feasibility and effects of a virtual HIIT vs. virtual MICT program on the physical, quality of life, and mental health of women with CIED. Furthermore, a qualitative approach is also necessary to understand patients' experiences, barriers, and facilitators of a virtual exercise intervention. This mixed-methods pilot randomized controlled trial will assess the feasibility of a 12-week virtual HIIT and MICT program in women with CIED.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It mentions that participants should be on optimal medical therapy, which suggests you may need to continue your current medications.

Is exercise training, like HIIT and MICT, safe for people with cardiovascular conditions?

Research shows that high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) are generally safe for people with cardiovascular conditions, with a low rate of major adverse events. In a review of 23 studies, only one major cardiovascular event occurred per 17,083 HIIT sessions, indicating a relatively low risk. ^{1 2 3 4 5}

How does the treatment of high-intensity interval training (HIIT) differ from other treatments for cardiovascular disease?

High-intensity interval training (HIIT) is unique because it involves short bursts of intense exercise followed by rest, which can improve heart health more effectively than moderate-intensity continuous training (MICT). Studies suggest that HIIT may increase exercise capacity and reduce the risk of heart-related issues more than traditional continuous exercise. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment High-intensity interval training (HIIT) and Moderate-intensity continuous training (MICT) for cardiovascular disease?

Research shows that high-intensity interval training (HIIT) can be more effective than moderate-intensity continuous training (MICT) in improving exercise capacity and reducing the risk of cardiovascular disease and mortality. HIIT has been found to increase peak oxygen uptake, which is a measure of how well your body uses oxygen during exercise, and improve overall heart health in patients with heart failure and coronary artery disease. ^{2 6 8 10 11}

Who Is on the Research Team?

Jennifer Reed, PhD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

This trial is for women with cardiac devices (CIED) who've had them for at least 6 months, can read English or French, and are able to do a CPET exercise test. They should be on optimal medical therapy and not already doing regular exercise more than twice a week. Women who are pregnant or without internet cannot join.

Inclusion Criteria

I am a woman with a cardiac implant for over 6 months.

I am a woman with a well-functioning cardiac device and on optimal medical therapy.

Patient is able to read and understand English or French

Exclusion Criteria

I am unable to sign a consent form.

Patient is currently participating in routine exercise training (>2x/week)

Pregnancy or patients who become pregnant during the 12-week intervention phase (the effects of interval training on an unborn fetus are unknown)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week virtual exercise program with either HIIT or MICT, conducted twice a week via Zoom.

12 weeks

24 virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after the exercise intervention, including assessments of cardiometabolic health indicators and mental health.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High-intensity interval training (HIIT)
• Moderate-intensity continuous exercise training (MICT)

Trial Overview The study compares two types of virtual exercise programs over 12 weeks: moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT). It aims to see which one better improves fitness, quality of life, and mental health in women with CIED.

How Is the Trial Designed?

Group I: Standard care + moderate-intensity continuous exercise training (MICT) Experimental Treatment 1 Intervention

Supervised virtual MICT exercise sessions for 12 weeks (2x/wk) using the platform Zoom Care.

Group II: Standard care + high-intensity interval training (HIIT) Experimental Treatment 1 Intervention

Supervised virtual HIIT exercise sessions for 12 weeks (2x/wk) using the platform Zoom Care.

High-intensity interval training (HIIT) is already approved in European Union, United States for the following indications:

Approved in European Union as High-Intensity Interval Training for:

• Cardiovascular rehabilitation
• Improvement of peak oxygen uptake (VO2 peak)
• Enhancement of physical functioning and quality of life

Approved in United States as High-Intensity Interval Training for:

• Cardiovascular rehabilitation
• Improvement of peak oxygen uptake (VO2 peak)
• Enhancement of physical functioning and quality of life

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Published Research Related to This Trial

High-intensity interval training (HIIT) significantly improves exercise capacity (peak VO2) in patients with coronary artery disease (CAD), especially in training sessions lasting less than eight weeks, compared to moderate-intensity continuous training (MICT).

HIIT also enhances important prognostic markers such as the anaerobic threshold (AT) and left ventricular ejection fraction (LVEF) in patients with CAD and heart failure (HF), indicating its potential benefits for heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of High-Intensity Interval Training on Exercise Capacity and Prognosis in Heart Failure and Coronary Artery Disease: A Systematic Review and Meta-Analysis. Wang, C., Xing, J., Zhao, B., et al.[2022]

High-intensity interval training (HIIT) is more effective than moderate-intensity continuous training (MICT) for improving cardiorespiratory fitness in patients with cardiovascular disease (CVD), with a significant increase in peak oxygen uptake (VO2peak) observed in a meta-analysis of 22 studies involving 949 participants.

The best results were achieved with medium-interval HIIT performed three times a week for more than 12 weeks, and HIIT was found to be safe, with fewer adverse events reported compared to MICT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of High-Intensity Interval vs. Moderate-Intensity Continuous Training on Cardiac Rehabilitation in Patients With Cardiovascular Disease: A Systematic Review and Meta-Analysis. Yue, T., Wang, Y., Liu, H., et al.[2022]

In a study of 81 heart disease patients with very high cardiovascular risk, both moderate and high-intensity interval training (MIIT and HIIT) were found to be safe, with no adverse outcomes reported during the training.

While there were no statistically significant differences in overall exercise improvements between the training types, the HIIT group showed a trend towards greater improvements in exercise tolerance, suggesting it may be more effective than continuous moderate intensity training (MICT).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and improvement in exercise tolerance with interval training vs moderate-intensity continuous training in heart disease patient of very high cardiovascular risk. Pineda-García, AD., Lara-Vargas, JA., Ku-González, A., et al.[2022]

A 6-month exercise program combining high intensity interval training (HIIT) and moderate intensity continuous training (MICT) showed similar improvements in cardiorespiratory fitness (CRF) and mental health markers (anxiety and depression) compared to a standard MICT program in stroke or TIA patients, with both exercise groups outperforming a control group.

Both exercise programs were well-accepted by participants, and the addition of HIIT was found to be safe, indicating that HIIT can be effectively integrated into rehabilitation for stroke patients without compromising safety or efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addition of high-intensity interval training to a moderate intensity continuous training cardiovascular rehabilitation program after ischemic cerebrovascular disease: A randomized controlled trial. Lapointe, T., Houle, J., Sia, YT., et al.[2023]

High intensity interval training (HIIT) significantly improves peak oxygen uptake (Peak VO2) in heart failure patients with reduced ejection fraction (HFrEF) compared to moderate intensity continuous training (MICT), based on a review of 13 studies involving 411 patients.

However, when comparing isocaloric exercise protocols, the benefits of HIIT over MICT diminish, indicating that the effectiveness of HIIT may depend on the specific training conditions and intensities used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High intensity interval training versus moderate intensity continuous training on exercise capacity and quality of life in patients with heart failure with reduced ejection fraction: A systematic review and meta-analysis. Gomes Neto, M., Durães, AR., Conceição, LSR., et al.[2018]

High-intensity, low-volume interval training (HIIT-low volume) and moderate-intensity continuous aerobic training (MICT) are both safe for adults with metabolic syndrome, with no serious adverse reactions reported during a 12-week supervised exercise program involving 60 participants.

While both training methods had similar rates of musculoskeletal events, HIIT-low volume was associated with a higher incidence of cardiovascular events, suggesting caution for individuals with specific health concerns, such as venous insufficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of High-Intensity, Low-Volume Interval Training or Continuous Aerobic Training in Adults With Metabolic Syndrome. Gallo-Villegas, J., Restrepo, D., Pérez, L., et al.[2023]

High-intensity interval training (HIIT) is as effective, if not more so, than traditional moderate-intensity continuous training (MICT) for patients with cardiovascular disease, based on a systematic review of 23 studies involving 1117 participants.

The safety profile of HIIT in cardiac rehabilitation is promising, with only one major cardiovascular adverse event reported per 17,083 training sessions, indicating that HIIT can be safely implemented in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. Wewege, MA., Ahn, D., Yu, J., et al.[2021]

A 12-week high-intensity interval training (HIIT) boxing program was found to be feasible and more effective than moderate-intensity continuous training (MICT) in improving body fat percentage, blood pressure, and health-related quality of life in obese adults.

Participants in the boxing group attended more sessions and had a lower dropout rate compared to the walking group, indicating better adherence to the HIIT program despite some adverse events, which were manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility and effectiveness of high-intensity boxing training versus moderate-intensity brisk walking in adults with abdominal obesity: a pilot study. Cheema, BS., Davies, TB., Stewart, M., et al.[2022]

In a study of 42 inactive obese middle-aged men, both high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT), as well as alternating between the two, led to a similar 15% increase in cardiovascular fitness (VO2max) after 16 weeks.

All exercise groups also experienced significant reductions in weight, body mass index (BMI), body fat percentage, and waist circumference, indicating that both training methods are effective for improving body composition without significant differences in blood markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternating high-intensity interval training and continuous training is efficacious in improving cardiometabolic health in obese middle-aged men. Poon, ET., Siu, PM., Wongpipit, W., et al.[2022]

A study involving 120 patients with chronic heart failure showed that the modified group-based high-intensity aerobic interval training (m-Ullevaal) significantly improved functional exercise capacity, left ventricular ejection fraction, perceived exertion, and quality of life compared to moderate-intensity continuous training (MICT) over a 12-week period.

The m-Ullevaal protocol demonstrated greater benefits than MICT, suggesting it should be considered as a preferred rehabilitation method for patients with chronic heart failure by physical and rehabilitation medicine physicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group-based cardiac rehabilitation interventions. A challenge for physical and rehabilitation medicine physicians: a randomized controlled trial. Papathanasiou, JV., Petrov, I., Tokmakova, MP., et al.[2021]

High-intensity interval training (HIIT) significantly improves peak oxygen uptake in patients with coronary artery disease (CAD) compared to moderate-intensity continuous training (MICT), based on a meta-analysis of 17 studies involving 902 patients.

Despite the improvement in oxygen uptake, there were no significant differences in blood pressure or heart rate between the HIIT and MICT groups, suggesting that both training methods may be safe and effective for CAD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of High-Intensity Interval Training on Exercise Capacity in Patients with Coronary Artery Disease: A Systematic Review and Meta-Analysis. Li, S., Chen, X., Jiao, H., et al.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

The Effects of High-Intensity Interval Training on Exercise Capacity and Prognosis in Heart Failure and Coronary Artery Disease: A Systematic Review and Meta-Analysis. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of High-Intensity Interval vs. Moderate-Intensity Continuous Training on Cardiac Rehabilitation in Patients With Cardiovascular Disease: A Systematic Review and Meta-Analysis. [2022]

3. Mexico pubmed.ncbi.nlm.nih.gov

Safety and improvement in exercise tolerance with interval training vs moderate-intensity continuous training in heart disease patient of very high cardiovascular risk. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Addition of high-intensity interval training to a moderate intensity continuous training cardiovascular rehabilitation program after ischemic cerebrovascular disease: A randomized controlled trial. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

High intensity interval training versus moderate intensity continuous training on exercise capacity and quality of life in patients with heart failure with reduced ejection fraction: A systematic review and meta-analysis. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of High-Intensity, Low-Volume Interval Training or Continuous Aerobic Training in Adults With Metabolic Syndrome. [2023]

7. England pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. [2021]

8. England pubmed.ncbi.nlm.nih.gov

The feasibility and effectiveness of high-intensity boxing training versus moderate-intensity brisk walking in adults with abdominal obesity: a pilot study. [2022]

9. Singapore pubmed.ncbi.nlm.nih.gov

Alternating high-intensity interval training and continuous training is efficacious in improving cardiometabolic health in obese middle-aged men. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

Group-based cardiac rehabilitation interventions. A challenge for physical and rehabilitation medicine physicians: a randomized controlled trial. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

The Effect of High-Intensity Interval Training on Exercise Capacity in Patients with Coronary Artery Disease: A Systematic Review and Meta-Analysis. [2023]