Cardiac Rehabilitation for Cardiovascular Disease

Overseen By Jenna Taylor, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Cerebrovascular, Neurological, Respiratory, others

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how exercise-based cardiac rehabilitation affects brain blood flow and cognitive function in people with cardiovascular disease. Participants will be divided into groups to receive different exercise programs, such as high-intensity interval training (HIIT) or moderate-intensity continuous training (MICT), and their results will be compared to a control group. The goal is to determine if exercise can improve or maintain cognitive abilities by positively influencing brain blood flow. Individuals who have experienced a cardiac event and are eligible for rehab might be a good fit for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance rehabilitation strategies for cardiovascular patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) are safe and well-tolerated for people in cardiac rehab. HIIT carries a low risk of serious heart problems in patients with coronary artery disease or heart failure. Studies indicate that HIIT can boost fitness and health without increasing health risks.

Similarly, MICT improves fitness and exercise ability without causing additional heart issues. This training also helps lower death rates and enhances quality of life for those with heart disease. Overall, both exercise programs are considered safe for people in cardiac rehab. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different styles of cardiac rehabilitation, which could reshape how we approach recovery for cardiovascular disease. Traditional rehab often focuses on moderate exercise, but this study is testing high-intensity interval training (HIIT), which alternates short bursts of intense activity with rest. This method may improve heart health more efficiently and in less time. Additionally, the trial includes an observational group to better understand outcomes in real-world settings. By comparing these approaches, the trial aims to find the most effective way to boost heart recovery and overall fitness.

What evidence suggests that this trial's treatments could be effective for cardiovascular disease?

This trial will compare different cardiac rehabilitation approaches for cardiovascular disease. Research has shown that exercise programs for heart health, such as high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT), can be very beneficial. Participants in this trial may be randomized to receive either HIIT or MICT. Studies have found that HIIT can boost heart fitness and lower the risk of heart disease, sometimes even more effectively than MICT. HIIT is also linked to fewer serious heart problems in individuals with coronary artery disease. Meanwhile, MICT reduces the risk of heart issues and death by focusing on longer, moderate workouts. Both HIIT and MICT are safe and improve overall heart fitness. ^{1 2 3 4 6}

Who Is on the Research Team?

Bruce D Johnson, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

Group I: Cardiac rehabilitation - observational Experimental Treatment 1 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 Treatment 1 Intervention

Patients attending cardiac rehabilitation randomized to HIIT.

Group III: Healthy control group Active Control 1 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 Control 1 Intervention

Patients attending cardiac rehabilitation randomized to MICT.

Group V: Cardiac rehabilitation - control Placebo Group 1 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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A study involving 40 patients with coronary artery disease showed that both standard cardiac rehabilitation and high-intensity interval training (HIIT) significantly improved functional capacity, lipid profiles, and quality of life after percutaneous coronary intervention.

HIIT was found to be at least as safe and effective as standard moderate-intensity exercise, with additional benefits in emotional well-being, highlighting its potential as a valuable alternative in cardiac rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High intensity interval training exercise as a novel protocol for cardiac rehabilitation program in ischemic Egyptian patients with mild left ventricular dysfunction. Abdelhalem, AM., Shabana, AM., Onsy, AM., et al.[2022]

Many leading cardiac rehabilitation guidelines from North America and Europe advocate for a progression from moderate- to vigorous-intensity aerobic exercise, along with resistance training, to enhance patient outcomes and quality of life.

Higher-intensity aerobic training is considered safe for cardiac rehabilitation patients and may lead to better results, suggesting a need for international consensus on exercise prescription in these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of guidelines for cardiac rehabilitation exercise programmes: Is there an international consensus? Price, KJ., Gordon, BA., Bird, SR., et al.[2022]

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 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]

In a study of 187 cardiac rehabilitation patients, both hybrid and virtual rehabilitation methods showed similar improvements in the 6-minute walk test compared to traditional in-person rehabilitation, indicating that these alternative delivery methods are effective.

While hybrid and virtual rehabilitation improved blood pressure control and anxiety levels similarly to in-person sessions, virtual patients showed less improvement in depression symptoms, suggesting that while these methods are effective, they may require additional support for mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes and Qualitative Perceptions of In-person, Hybrid, and Virtual Cardiac Rehabilitation. Ganeshan, S., Jackson, H., Grandis, DJ., et al.[2023]

eHealth interventions significantly increase moderate-to-vigorous intensity physical activity among patients in cardiac rehabilitation, with a standardized mean difference of 0.18, based on a meta-analysis of 29 studies involving various delivery methods.

Despite the increase in physical activity, eHealth interventions did not show improvements in cardiovascular-related outcomes such as cardiorespiratory fitness, waist circumference, or systolic blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of eHealth Interventions on Moderate-to-Vigorous Intensity Physical Activity Among Patients in Cardiac Rehabilitation: Systematic Review and Meta-analysis. Yu, T., Xu, H., Sui, X., et al.[2023]

A 6-week high-intensity interval training (HIIT) program for 29 patients with coronary artery disease (CAD) was found to be safe, with no cardiovascular-related adverse events reported during the sessions.

Participants showed significant improvements in peak aerobic capacity (+12%), blood pressure (systolic -7 mmHg), and total body fat (-4%), while also reporting high enjoyment levels (5.5 out of 7), suggesting that HIIT could be a sustainable and effective rehabilitation strategy for CAD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity interval training for patients with coronary artery disease: Finding the optimal balance. Keech, A., Holgate, K., Fildes, J., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to High-Intensity Interval Training in Cardiac Rehabilitation: A REVIEW AND RECOMMENDATIONS. Taylor, JL., Holland, DJ., Keating, SE., et al.[2023]

A systematic review of 60 randomized clinical trials involving 19,411 patients found that only center-based cardiac rehabilitation significantly reduced all-cause mortality compared to usual care, indicating its effectiveness for patients with coronary heart disease.

While combined cardiac rehabilitation showed a high probability of being effective, its results were not statistically significant, suggesting that further research is needed to explore the efficacy of home- and tele-based rehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Different Types of Exercise-Based Cardiac Rehabilitation on Coronary Heart Disease: a Network Meta-analysis. Xia, TL., Huang, FY., Peng, Y., et al.[2022]

In a study involving 25,420 patients undergoing cardiac rehabilitation, the rate of severe cardiovascular events during exercise training was very low, with only 20 serious events reported, indicating a high level of safety for patients participating in these programs.

The study found that the event rate was 1 per 49,565 patient-hours of exercise training, and there were no fatal complications or emergency defibrillations, suggesting that supervised exercise training is a safe practice for cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation. Pavy, B., Iliou, MC., Meurin, P., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shorter Wait Times to Cardiac Rehabilitation Associated With Greater Exercise Capacity Improvements: A MULTISITE STUDY. Candelaria, D., Zecchin, R., Ferry, C., et al.[2022]

Cardiac rehabilitation training, including both moderate-intensity continuous training (MCT) and high-intensity interval training (HIIT), can improve cardiac function indicators and self-care abilities in patients with heart disease, based on a meta-analysis of 8 randomized controlled trials involving 465 patients.

While the study found no statistically significant differences in peak oxygen uptake and left ventricular ejection fraction between training intensities, it highlights the need for larger, multicenter, and long-term studies to confirm these findings and better understand the effects of different training intensities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cardiac rehabilitation training on patients with coronary heart disease: a systematic review and meta-analysis. Li, J., Li, Y., Gong, F., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6760312/

High-Intensity Interval Training in Cardiac Rehabilitation - PMC HIIT has been found to be as effective, if not superior, to MICT with respect to improving clinical outcomes for older patients with CVD.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36753063/

High-intensity interval training in cardiac rehabilitation (HIIT ... Conclusions: In stable CAD, low-volume HIIT improved cardiorespiratory fitness more than MISS by a clinically meaningful margin. Low-volume HIIT ...

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.118.009305

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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0003999323005294

Cost-effectiveness of High-Intensity Interval Training (HIIT) ... In a recent randomized controlled trial, high-intensity interval exercise training (HIIT) was more effective than moderate intensity steady-state (MISS) ...

5. academic.oup.com academic.oup.com/eurjpc/article/30/9/745/7031580

High-intensity interval training in cardiac rehabilitation: a multi ... The primary outcome was the change in cardiorespiratory fitness [peak oxygen uptake (VO2 peak)] at 8 week follow-up. Secondary outcomes included ...

6. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2769884

Short-term and Long-term Feasibility, Safety, and Efficacy ... This randomized clinical trial compares high-intensity interval training with moderate-intensity continuous training for feasibility, safety ...