20 Participants Needed

Exercise Training for Cardiovascular Disease

(CIED-EX Trial)

JR
IM
Overseen ByIsabela Marcal, MSc
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Ottawa Heart Institute Research Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12367

Who Is on the Research Team?

JR

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
See 1 more

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)
See 7 more

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?
2Treatment groups
Experimental Treatment
Group I: Standard care + moderate-intensity continuous exercise training (MICT)Experimental Treatment1 Intervention
Group II: Standard care + high-intensity interval training (HIIT)Experimental Treatment1 Intervention

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

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

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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.
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.
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.
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]

Citations

Narrative Review of High-Intensity Interval Training: Positive ...Results: HIIT significantly improved vascular function, evidenced by reductions in systolic and diastolic blood pressure and enhanced flow- ...
High-intensity interval training for health benefits and care of ...According to several RCTs, HIIT was superior in improving VO2peak in 60% (6/10) of patients with coronary artery disease and in 45.6% of those with CHF (Table 4) ...
High‐Intensity Interval Training for Patients With ...HIIT has shown a relatively low rate of major adverse cardiovascular events for patients with coronary artery disease or heart failure when applied within CR ...
Physiological and psychological outcomes of high intensity ...High intensity interval training improves oxygen consumption, ejection fraction and quality of life in patients with heart failure.
Effects of high-intensity interval training on cardiopulmonary ...Studies suggest that HIIT not only enhances exercise capacity [18] and lowers cardiovascular risk factors [19] but also improves quality of life ...
Short-term and Long-term Feasibility, Safety, and Efficacy ...HIIT was feasible and safe, with similar adherence to MICT over 12-month follow-up. These findings support inclusion of HIIT in cardiac ...
The effectiveness of a high-intensity interval exercise on ...These intense workouts performed at 80–95% of maximum heart rate and combined with low-intensity recovery periods yield effective results in a ...
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