172 Participants Needed

Exercise Training for Heart Disease

(EXCEED2 Trial)

JR
MM
Overseen ByMatheus Mistura, 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)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This study will compare the effects of two different types of training on exercise capacity in women with coronary heart disease (CHD). Participants will be randomized into either the virtual high-intensity interval training (HIIT) or the virtual moderate-to-vigorous intensity continuous training (MICT). After randomization, patients will exercise twice a week, for 12 weeks. The sessions will be conducted virtually. Patients will undergo a maximal exercise test, cardiometabolic indicators (height (cm), body mass (kg), body composition (%), waist circumference (cm) and, resting blood pressure) and complete questionnaires about quality of life, mental health, self-determined motivation, self-efficacy and enjoyment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Exercise Training, Cardiac Rehabilitation, Physical Therapy, Exercise Intervention for heart disease?

Research shows that regular exercise training can improve heart health by enhancing exercise tolerance, reducing stress on the heart, and improving quality of life for heart disease patients. Exercise is recommended as a key part of cardiac rehabilitation, helping to prevent further heart issues and improve overall cardiovascular health.12345

Is exercise training safe for people with heart disease?

Exercise training, including cardiac rehabilitation, is generally safe for heart disease patients when done under medical supervision. Studies show that it can be performed safely, especially when guidelines are followed, and it may even reduce mortality and improve quality of life.678910

How does exercise training differ from other treatments for heart disease?

Exercise training, as part of cardiac rehabilitation, is unique because it combines physical activity with behavioral and psychosocial interventions to improve heart function and quality of life. Unlike medications, it focuses on enhancing physical endurance, reducing symptoms, and improving psychological well-being through a personalized exercise regimen.1112131415

Research Team

JR

Jennifer Reed, PhD

Principal Investigator

Ottawa Heart Institute Research Corporation

Eligibility Criteria

This trial is for women with coronary heart disease (CHD) who are interested in participating in a virtual exercise program. The study requires participants to train twice a week for 12 weeks, but specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I can read and understand English or French.
I am a woman who had a heart procedure or event at least 4 weeks ago.
Patient is able to perform a symptom limited CPET

Exclusion Criteria

Patient currently participating in routine exercise training (>2x/week)
I have severe heart or lung conditions.
I am not willing to be assigned randomly to high-intensity or moderate-intensity exercise.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into either virtual HIIT or MICT and exercise twice a week for 12 weeks

12 weeks
24 virtual sessions

Follow-up

Participants are monitored for changes in health measures and exercise capacity

14 weeks

Treatment Details

Interventions

  • Exercise Training
Trial Overview The study is testing the effectiveness of two different virtual exercise programs: high-intensity interval training (HIIT) and moderate-to-vigorous intensity continuous training (MICT). Women will be randomly assigned to one of these programs to see which is better at improving exercise capacity and heart health.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: standard care + moderate-intensity continuous exercise trainingExperimental Treatment1 Intervention
2 days/week Warm-up: 60-70% peak HR - 10min Training: 70-85% peak HR - 35min Cool-down: 60-70% peak HR - 15min
Group II: standard care + high-intensity interval trainingExperimental Treatment1 Intervention
2 days/week Warm-up: 60-70% peak HR - 10min Training: 85-95% peak HR - 25 minutes (4x4-minutes of high-intensity intervals interspersed with 3 minutes of low-intensity intervals) Cool-down: 60-70% peak HR - 10min

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

Regular exercise training is highly recommended for heart failure patients, supported by strong evidence, yet many patients remain inactive due to various barriers.
Home telerehabilitation is proposed as an effective solution to encourage physical activity among heart failure patients, addressing the limitations of traditional outpatient rehabilitation.
How to do: telerehabilitation in heart failure patients.Piotrowicz, E.[2019]
Exercise training significantly helps in preventing and modifying cardiovascular diseases and reducing mortality, highlighting its importance in patient care.
Patients with acute cardiovascular conditions benefit from structured cardiac rehabilitation programs, while those with chronic conditions should engage in lifelong home-based exercise routines that include aerobic, resistance, flexibility, and balance activities.
Exercise in cardiovascular diseases.Perez-Terzic, CM.[2022]
Recent studies indicate that regular exercise training is safe and effective for patients with stable Class II and III heart failure, improving exercise tolerance and quality of life.
Moderate physical activity, such as 30 to 60 minutes of walking or cycling 3 to 5 days a week, can help reverse some muscle abnormalities and reduce stress on the heart, but more research is needed to fully understand its impact on long-term health outcomes.
Exercise training in heart failure.Afzal, A., Brawner, CA., Keteyian, SJ.[2019]

References

How to do: telerehabilitation in heart failure patients. [2019]
Exercise in cardiovascular diseases. [2022]
Exercise training in heart failure. [2019]
Physical Training and Cardiac Rehabilitation in Heart Failure Patients. [2018]
Exercise and cardiovascular diseases. [2016]
Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation. [2022]
[Heart patient and sports]. [2008]
Exercise training in patients with heart failure: clinical outcomes, safety, and indications. [2021]
Exploring participants' perspectives on adverse events due to resistance training: a qualitative study. [2023]
Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
The role of exercise therapy in patients with impaired ventricular function and chronic heart failure. [2007]
[Role of rehabilitation in the treatment of chronic heart insufficiency]. [2019]
Exercise training in coronary artery disease. [2007]
Types of exercise. Arm-leg and static-dynamic. [2007]
Exercise following myocardial infarction. Current recommendations. [2018]
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