45 Participants Needed

Cardiac Rehabilitation for Cardiovascular Disease

JT
Overseen ByJenna Taylor, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.

What data supports the idea that Cardiac Rehabilitation for Cardiovascular Disease is an effective treatment?

The available research shows that Cardiac Rehabilitation (CR) is effective in helping people with heart disease. One study highlights that exercise-based CR, including both moderate and high-intensity training, plays a major role in reducing the risk of death and health problems in patients with coronary artery disease. Another study found that high-intensity interval training (HIIT) is becoming popular because it improves fitness levels more than moderate exercise. Additionally, a systematic review suggests that both moderate and high-intensity training methods in CR can improve the health outcomes of heart disease patients. Furthermore, a study on home-based telemonitored CR showed that it can be as effective as traditional outpatient programs, offering flexibility and convenience for patients. Overall, these studies support the effectiveness of CR in improving the health and quality of life for people with heart conditions.12345

What safety data is available for cardiac rehabilitation treatments?

The safety data for cardiac rehabilitation, particularly focusing on high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT), indicates a relatively low rate of major adverse cardiovascular events. A systematic review of 23 studies involving 1117 participants reported one major cardiovascular event per 17,083 training sessions for HIIT. Minor cardiovascular and noncardiovascular events, such as musculoskeletal complaints, were also noted. Overall, HIIT and MICT are considered safe for patients with coronary artery disease or heart failure in cardiac rehabilitation settings.46789

Is cardiac rehabilitation a promising treatment for heart disease?

Yes, cardiac rehabilitation is a promising treatment for heart disease. It helps reduce the risk of death and illness in people with heart problems. Different types of exercises, like high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT), are used to improve heart health. Cardiac rehabilitation can be done in-person or online, making it flexible and accessible for many people.410111213

What is the purpose of this trial?

This study is being done to better understand the influence of cardiovascular disease on brain blood flow regulation and cognitive function, determine whether exercise-based cardiac rehabilitation can lead to better regulation of brain blood flow that may help to improve or maintain cognitive function, and determine whether exercise intensity influences changes in brain blood flow regulation and cognitive function.

Research Team

BD

Bruce D Johnson, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for people aged 40 and older who are eligible for cardiac rehab after a heart-related hospital stay. It's open to those with coronary artery disease but not to individuals previously diagnosed with cardiovascular diseases or risk factors like high blood pressure, high cholesterol, diabetes, obesity (BMI >30), or smoking.

Inclusion Criteria

I am over 40 and qualify for heart rehab after a heart-related hospital stay.
I am over 40, have never had heart disease, and don't have major heart disease risk factors.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either high intensity interval training (HIIT) or moderate intensity continuous training (MICT) as part of cardiac rehabilitation

12 weeks
Regular visits as part of cardiac rehabilitation program

Follow-up

Participants are monitored for changes in cerebral blood flow regulation and cognitive function

3 months
Follow-up assessments at 3 months

Observational Control

Participants who decline cardiac rehabilitation are monitored as a control group

12 weeks

Treatment Details

Interventions

  • Cardiac rehabilitation - control
  • Cardiac rehabilitation - high intensity interval training (HIIT)
  • Cardiac rehabilitation - moderate intensity continuous training (MICT)
  • Cardiac rehabilitation - observational
Trial Overview The study tests how different intensities of exercise in cardiac rehabilitation affect brain blood flow and cognitive function. Participants will be observed during regular control sessions, high intensity interval training (HIIT), and moderate intensity continuous training (MICT).
Participant Groups
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Cardiac rehabilitation - observationalExperimental Treatment1 Intervention
This observational group will include patients who are completing an exercise-based cardiac rehabilitation program in line with standard care but are not part of the randomized exercise protocol groups (HIIT or MICT). Participants in this group will be combined with HIIT and MICT (as exercise-based cardiac rehabilitation group) for Aims 1b and 2b.
Group II: Cardiac rehabilitation - High intensity interval training (HIIT)Experimental Treatment1 Intervention
Patients attending cardiac rehabilitation randomized to HIIT.
Group III: Healthy control groupActive Control1 Intervention
Healthy age-matched adults without cardiovascular disease, who will complete baseline assessments only. No intervention period.
Group IV: Cardiac rehabilitation - Moderate intensity continuous training (MICT)Active Control1 Intervention
Patients attending cardiac rehabilitation randomized to MICT.
Group V: Cardiac rehabilitation - controlPlacebo Group1 Intervention
The control group (12 week period) will include participants who have declined cardiac rehabilitation.

Cardiac rehabilitation - control is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Cardiac rehabilitation for:
  • Cardiovascular disease
  • Heart failure
  • Coronary artery disease
🇺🇸
Approved in United States as Cardiac rehabilitation for:
  • Cardiovascular disease
  • Heart failure
  • Coronary artery disease
🇨🇦
Approved in Canada as Cardiac rehabilitation for:
  • Cardiovascular disease
  • Heart failure
  • Coronary artery disease
🇯🇵
Approved in Japan as Cardiac rehabilitation for:
  • Cardiovascular disease
  • Heart failure
  • Coronary artery disease
🇨🇳
Approved in China as Cardiac rehabilitation for:
  • Cardiovascular disease
  • Heart failure
  • Coronary artery disease
🇨🇭
Approved in Switzerland as Cardiac rehabilitation for:
  • Cardiovascular disease
  • Heart failure
  • Coronary artery disease

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Findings from Research

Home-based telemonitored cardiac rehabilitation (HTCR) is as effective as standard outpatient cardiac rehabilitation (SCR) for heart failure patients, showing significant improvements in key health parameters after 8 weeks of treatment.
HTCR demonstrated better adherence, with all participants completing the program compared to a 20% dropout rate in the SCR group, suggesting it may be a more acceptable option for patients with heart failure.
A new model of home-based telemonitored cardiac rehabilitation in patients with heart failure: effectiveness, quality of life, and adherence.Piotrowicz, E., Baranowski, R., Bilinska, M., et al.[2022]
Adherence to high-intensity interval training (HIIT) sessions among cardiac rehabilitation patients was found to be high and comparable to that of moderate-intensity exercise, indicating that patients are willing to participate in this more intense training.
However, adherence to the specific intensity and duration of HIIT was variable and often underreported, suggesting a need for better measurement and reporting practices to accurately assess the effectiveness of HIIT in improving cardiorespiratory fitness.
Adherence to High-Intensity Interval Training in Cardiac Rehabilitation: A REVIEW AND RECOMMENDATIONS.Taylor, JL., Holland, DJ., Keating, SE., et al.[2023]
In a study of 894 patients with coronary heart disease undergoing cardiac rehabilitation (CR), those who experienced shorter wait times before starting the program showed significantly greater improvements in exercise capacity, with an average increase of 70.4 meters in the 6-minute walk test.
The findings suggest that CR program coordinators should focus on reducing wait times to enhance the effectiveness of rehabilitation, as younger age and female sex were also identified as factors influencing exercise capacity outcomes.
Shorter Wait Times to Cardiac Rehabilitation Associated With Greater Exercise Capacity Improvements: A MULTISITE STUDY.Candelaria, D., Zecchin, R., Ferry, C., et al.[2022]

References

A new model of home-based telemonitored cardiac rehabilitation in patients with heart failure: effectiveness, quality of life, and adherence. [2022]
Adherence to High-Intensity Interval Training in Cardiac Rehabilitation: A REVIEW AND RECOMMENDATIONS. [2023]
Shorter Wait Times to Cardiac Rehabilitation Associated With Greater Exercise Capacity Improvements: A MULTISITE STUDY. [2022]
High intensity interval training exercise as a novel protocol for cardiac rehabilitation program in ischemic Egyptian patients with mild left ventricular dysfunction. [2022]
Effect of cardiac rehabilitation training on patients with coronary heart disease: a systematic review and meta-analysis. [2021]
High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. [2021]
High-intensity interval training for patients with coronary artery disease: Finding the optimal balance. [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]
Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Efficacy of Different Types of Exercise-Based Cardiac Rehabilitation on Coronary Heart Disease: a Network Meta-analysis. [2022]
Effectiveness of eHealth Interventions on Moderate-to-Vigorous Intensity Physical Activity Among Patients in Cardiac Rehabilitation: Systematic Review and Meta-analysis. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Clinical Outcomes and Qualitative Perceptions of In-person, Hybrid, and Virtual Cardiac Rehabilitation. [2023]
A review of guidelines for cardiac rehabilitation exercise programmes: Is there an international consensus? [2022]
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