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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help women with cardiac implantable electronic devices (CIED) enhance their fitness and quality of life. It compares two exercise programs: high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT), both conducted virtually. The researchers aim to determine which program more effectively improves physical health, anxiety levels, and overall well-being. Women who have had a CIED for at least six months, are not currently exercising regularly, and have internet access may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve fitness strategies for women with CIEDs.

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.

What prior data suggests that these exercise programs are safe for women with CIED?

Research has shown that high-intensity interval training (HIIT) is generally safe for individuals with heart conditions like coronary artery disease and heart failure. Studies have found that serious heart-related problems rarely occur during HIIT exercises. Additionally, HIIT can enhance heart fitness and overall health.

Moderate-intensity continuous exercise training (MICT) is also well-tolerated. Research comparing HIIT and MICT indicates that both exercise types have similar positive effects on the quality of life and mental health of those with heart conditions. This suggests that MICT, which involves exercising at a steady pace, is safe for individuals with heart issues.

Both exercise methods are considered safe and beneficial for improving heart health, making them good options for people with heart conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these exercise programs for cardiovascular disease because they offer a fresh approach to managing the condition through virtual platforms. Unlike traditional exercise regimens that might require in-person attendance, these treatments use Zoom Care to provide supervised sessions remotely, making them more accessible to participants. High-intensity interval training (HIIT) is particularly promising as it alternates between short bursts of intense activity and rest, potentially improving heart health more efficiently than continuous moderate exercise. Meanwhile, moderate-intensity continuous exercise training (MICT) provides a steady, manageable workout that can be sustained over time, offering flexibility and consistency without needing to visit a physical location.

What evidence suggests that this trial's treatments could be effective for women with CIED?

Research has shown that high-intensity interval training (HIIT), one of the treatments in this trial, can greatly improve heart health. It enhances exercise capacity, reduces the risk of heart problems, and improves the quality of life for individuals with heart conditions. In many cases, HIIT boosts fitness levels more effectively than moderate-intensity continuous training (MICT), another treatment option in this trial. MICT also lowers the risk of heart disease and improves overall fitness. Both HIIT and MICT can enhance quality of life and mental health, but HIIT often results in greater fitness improvements. ^{1 2 3 6 7}

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

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) 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]

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]

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]

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]

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]

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]

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]

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]

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]

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