Aerobic Fitness for Heart Problems

Overseen By Patrick Savage, Research Coordinator

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Vermont Medical Center

Disqualifiers: Active malignancy, Unwilling to comply, Submaximal performance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

114 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new exercise methods to help older adults recover after heart problems. It compares high-intensity interval training (HIIT) with the usual moderate-intensity continuous training (MICT) to determine which more effectively improves aerobic fitness and function. Participants include those who recently underwent heart treatments, such as stents or valve replacements, and are already in cardiac rehab. The goal is to reduce disability and improve health outcomes for these patients. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance recovery strategies for heart patients.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that this training regimen is safe for cardiac patients?

Research has shown that high-intensity interval training (HIIT) is generally safe for people with heart conditions. One study reported only a few issues, such as two nonfatal heart attacks, occurring at a rate of one for every 23,182 hours of training. This rate is similar to moderate-intensity continuous training (MICT), which experienced one fatal heart event. Another study found that HIIT was as safe as MICT over a year, with participants adhering equally well to both exercise types.

For moderate-intensity continuous training (MICT), research suggests it is safe and can be performed at home by heart patients. MICT has improved heart function and is considered safe when tailored to the individual. Both HIIT and MICT have been found to enhance heart health without a high risk of serious problems.

Overall, both HIIT and MICT are well-tolerated by heart patients and have similar safety levels. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore different intensities of exercise for heart health. Unlike standard cardiac rehabilitation, which typically involves moderate-intensity continuous training (MICT), this trial compares it with high-intensity interval training (HIIT). HIIT is unique because it involves short bursts of intense exercise followed by rest, potentially offering faster improvements in cardiovascular fitness and recovery. This could provide a more effective and time-efficient option for patients recovering from heart events like myocardial infarction or angioplasty.

What evidence suggests that this trial's treatments could be effective for heart problems?

This trial will compare high-intensity interval training (HIIT) with moderate-intensity continuous training (MICT) for patients in cardiac rehabilitation. Research has shown that HIIT, which participants in one arm of this trial may receive, can significantly reduce body fat and improve cholesterol levels in these patients. It also carries a low risk of causing serious heart problems in individuals with coronary artery disease or heart failure. Studies have found that HIIT enhances heart function, particularly in improving the heart's ability to contract.

Meanwhile, MICT, which participants in another arm of this trial may receive, is also important for enhancing physical ability and overall health after a heart attack. While both HIIT and MICT similarly boost quality of life and mental health, HIIT generally excels in improving heart fitness, as evidenced by higher peak oxygen uptake (VO2peak). Both exercise types offer benefits, but HIIT often yields better results in certain aspects of heart health. ^{2 6 7 8 9}

Who Is on the Research Team?

Sherrie Khadanga MD, Principal Investigator, MD

Principal Investigator

University of Vermont Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 65 who can walk and are in cardiac rehab after a heart attack or heart procedure. They must be willing to follow the exercise plan they're given, and not have active cancer (except certain skin or low-grade prostate cancers) or poor performance on an initial exercise test.

Inclusion Criteria

I can walk on my own.

I am in a heart rehab program after a heart attack or heart procedure.

I am older than 65.

Exclusion Criteria

Have a submaximal performance on entry exercise tolerance test, defined as respiratory exchange ratio <1.0

I have cancer that is not low-grade prostate or non-melanoma skin cancer.

Unwilling to comply with the exercise prescription they may be assigned to

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+HIRT) or moderate intensity continuous training (MICT+MIRT) to improve aerobic fitness and physical function

16 weeks

Regular visits for exercise sessions

Follow-up

Participants are monitored for maintenance of fitness and other health outcomes after the intervention

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HIIT
• MICT

Trial Overview

The study tests whether high intensity interval training (HIIT) or moderate intensity continuous training (MICT) is better at improving fitness and physical function in older adults recovering from heart issues, with the aim of reducing disability and enhancing clinical outcomes.

How Is the Trial Designed?

Group I: Usual Care Group Experimental Treatment 1 Intervention

Patients who recently experienced a myocardial infarction (MI) or percutaneous intervention (PCI; angioplasty, stent placement or valve replacement) and enroll in Phase 2 Cardiac Rehabilitation (CR) may be randomized to Moderate intensity training

Group II: Intervention Group Experimental Treatment 1 Intervention

Patients who recently experienced a myocardial infarction (MI) or percutaneous intervention (PCI; angioplasty, stent placement or valve replacement) and enroll in Phase 2 Cardiac Rehabilitation (CR) may be randomized to High intensity training

Who Is Running the Clinical Trial?

University of Vermont Medical Center

Lead Sponsor

Trials

46

Recruited

25,900+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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]

High-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) both significantly reduce cardiovascular disease risk factors, including weight, BMI, body fat percentage, and total cholesterol, while also improving VO2max in adults with overweight and obesity.

HIIT is particularly effective in enhancing cardiopulmonary fitness compared to MICT, especially when HIIT intervals are 2 minutes or longer, while requiring less overall training time per session.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of HIIT and MICT on cardiovascular risk factors in adults with overweight and/or obesity: A meta-analysis. Su, L., Fu, J., Sun, S., et al.[2020]

Higher-intensity interval training (HIIT) was safely integrated into a standard cardiac rehabilitation program for 39 patients, with no hospitalizations reported during or after exercise, indicating its safety for patients with stable coronary heart disease.

HIIT led to a significantly greater improvement in peak oxygen uptake (3.6 mL·kg⁻¹·min⁻¹) compared to moderate-intensity continuous training (1.7 mL·kg⁻¹·min⁻¹), demonstrating its efficacy in enhancing cardiorespiratory fitness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Greater improvement in cardiorespiratory fitness using higher-intensity interval training in the standard cardiac rehabilitation setting. Keteyian, SJ., Hibner, BA., Bronsteen, K., et al.[2022]

High-intensity interval training (HIIT) can lead to equal or greater improvements in aerobic capacity compared to traditional moderate-intensity continuous training (MICT), while also positively affecting body composition, glucose metabolism, blood pressure, and quality of life.

HIIT offers a significant time advantage, allowing individuals to achieve the same energy expenditure in a shorter duration, making it a practical option for both healthy adults and those with cardiovascular diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salutary effects of high-intensity interval training in persons with elevated cardiovascular risk. Fleg, JL.[2018]

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]

A scoping review of 69 studies on high-intensity interval training (HIIT) in older adults found that HIIT protocols are generally well-tolerated and can provide significant health benefits, particularly in improving cardiorespiratory fitness.

Most research has focused on healthy older adults, highlighting a need for larger studies and more investigation into HIIT's effects on older adults with various health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training in Older Adults: a Scoping Review. Marriott, CFS., Petrella, AFM., Marriott, ECS., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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, low-volume interval training (HIIT-low volume) and moderate-intensity continuous aerobic training (MICT) are both safe for adults with metabolic syndrome, with no serious adverse reactions reported during a 12-week supervised exercise program involving 60 participants.

While both training methods had similar rates of musculoskeletal events, HIIT-low volume was associated with a higher incidence of cardiovascular events, suggesting caution for individuals with specific health concerns, such as venous insufficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of High-Intensity, Low-Volume Interval Training or Continuous Aerobic Training in Adults With Metabolic Syndrome. Gallo-Villegas, J., Restrepo, D., Pérez, L., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6755673/

High-Intensity Interval Training in Cardiac Rehabilitation

Our data suggest supervised HIIT results in significant reductions in total fat mass and abdominal fat percentage, and improved lipid profile in CR patients ...

2.

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 ...

3.

jacc.org

jacc.org/doi/10.1016/S0735-1097%2824%2903746-X

EFFECTS OF HIGH INTENSITY INTERVAL TRAINING ON ...

HIIT group showed significant improvement in global longitudinal strain (GLS) (MD= 0.52; CI: 0.04,0.99; p < 0.05; I2= 0%), however, no significant improvement ...

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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04863677

The Effect of HIIT, MICT in Patients With Myocardial Infarction

This study will investigate the effect of a 12-weeks cardiac rehabilitation training (HIIT, MICT) program on VO2peak and cardiac fibrosis in patients, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8046134/

Effects of high‐intensity interval training in patients with ...

HIIT programme appears to be favourable for CAD patients after PCI by improving cardiopulmonary function, such as LVEF and VO 2peak, as well as reducing late ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02627586

High-Intensity Interval Training Early After Left Ventricular ...

Several studies have shown that high-intensity interval training (HIIT) is more effective than moderate-intensity continuous exercise training (MICE) at ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S1877065721000087

Effect of self-tailored high-intensity interval training versus ...

Self-tailored HIIT was feasible in patients early after STEMI. It was more strenuous but not superior nor more time-efficient than MICE in improving peak VO 2.

9.

jamanetwork.com

jamanetwork.com/journals/jamacardiology/fullarticle/2769884

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 ...