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)

Trial Summary

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 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.12345

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.36789

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.1231011

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.

Research Team

JR

Jennifer Reed, PhD

Principal Investigator

Ottawa Heart Institute Research Corporation

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Standard care + moderate-intensity continuous exercise training (MICT)Experimental Treatment1 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 Treatment1 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:

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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
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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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials
200
Recruited
95,800+

Findings from Research

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

References

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]
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]
Safety and improvement in exercise tolerance with interval training vs moderate-intensity continuous training in heart disease patient of very high cardiovascular risk. [2022]
Addition of high-intensity interval training to a moderate intensity continuous training cardiovascular rehabilitation program after ischemic cerebrovascular disease: A randomized controlled trial. [2023]
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]
Safety of High-Intensity, Low-Volume Interval Training or Continuous Aerobic Training in Adults With Metabolic Syndrome. [2023]
High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. [2021]
The feasibility and effectiveness of high-intensity boxing training versus moderate-intensity brisk walking in adults with abdominal obesity: a pilot study. [2022]
Alternating high-intensity interval training and continuous training is efficacious in improving cardiometabolic health in obese middle-aged men. [2022]
Group-based cardiac rehabilitation interventions. A challenge for physical and rehabilitation medicine physicians: a randomized controlled trial. [2021]
11.United Statespubmed.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]
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