Exercise Intervention for Cardiometabolic Health

(PACE Trial)

Recruiting at 1 trial location

Overseen By Vy Nguyen, B.S.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Smoking, Pregnancy, Psychiatric illness, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how daily rhythms (circadian system) and exercise interact to impact health, especially in conditions like heart disease and diabetes. Participants will follow two different exercise routines, consume identical meals, and provide blood, urine, and saliva samples for data collection. The trial suits individuals who can perform moderate exercise, have a body mass index (BMI) between 18.5 and 34.9, and do not have chronic illnesses. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on health and exercise.

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's best to discuss this with the study team.

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

Research shows that exercise programs are generally safe for most people. One study found that regular physical activity can lower the risk of heart disease and improve overall health. Another study showed that staying active can reduce the risk of developing conditions related to heart and metabolic health.

Regarding safety, a study on a 6-month exercise program found it well-tolerated by participants, with most experiencing no serious side effects. Exercise offers many health benefits, such as better heart function and physical fitness, with few risks when done in moderation.

For those considering joining a trial, exercise has a history of being safe and beneficial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise interventions being studied for cardiometabolic health because they offer a novel, non-pharmacological approach to improving heart and metabolic health. Unlike standard treatments like medication and dietary changes, these interventions focus on specific exercise sequences that might maximize health benefits. By comparing different exercise orders—Exercise A first, then B, and vice versa—the trial aims to uncover the most effective sequence for boosting cardiovascular and metabolic functions. This could lead to tailored exercise plans that are more effective and accessible than current options.

What evidence suggests that this trial's exercise interventions could be effective for cardiometabolic health?

Research shows that regular exercise can greatly improve heart and metabolic health. Studies have found that exercise lowers the risk of heart disease and helps prevent heart attacks. One study discovered that a 20-week program of both aerobic activities (like walking or cycling) and resistance training (like weightlifting) improved body shape, fitness, and heart health. Another study found that exercise programs with varied activities were particularly effective at increasing physical activity in people with heart and metabolic concerns. This trial will compare two different exercise interventions: the Exercise A-B Intervention and the Exercise B-A Intervention, to evaluate their effectiveness in boosting heart and metabolic health. Overall, exercise is a powerful way to enhance these health outcomes. ^{1 2 6 7 8}

Who Is on the Research Team?

Jingyi Qian, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 20-45 with a BMI of 20-34.9, without any serious health issues like heart disease or cancer. Participants must be willing to follow the study's rules, including staying in the hospital and doing moderate exercise.

Inclusion Criteria

Willing to adhere to the protocol requirements for the duration of the study

Body mass index (BMI) 20-34.9 kg/m2

I do not have any serious long-term health conditions.

Exclusion Criteria

Currently pregnant or breastfeeding

History of drug or alcohol dependency

History of psychiatric illness or disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Stay 1

Participants complete the first inpatient stay, perform moderate exercise, are provided with identical meals, and have frequent blood draws

1 week

1 inpatient visit

Inpatient Stay 2

Participants complete the second inpatient stay, perform moderate exercise, are provided with identical meals, and have frequent blood draws

1 week

1 inpatient visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise intervention

Trial Overview The study aims to see how our body clocks affect physical activity by having participants stay twice in a clinic, do some exercise, eat set meals, and give blood, urine, and saliva samples for testing.

How Is the Trial Designed?

Group I: Exercise B-A Intervention Experimental Treatment 1 Intervention

The Exercise B first, then the Exercise A intervention.

Group II: Exercise A-B Intervention Experimental Treatment 1 Intervention

The Exercise A first, then the Exercise B intervention.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Cardiac rehabilitation is crucial for patients with coronary heart disease, offering significant physiological, psychological, and prognostic benefits, and is structured into three phases: acute care, outpatient, and further conditioning programs.

Physical therapists play a vital role in implementing exercise testing and progressive activity programs, with data from Tufts New England Medical Center showing measurable improvements in cardiovascular health for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation. An overview. Hoskins, TA., Habasevich, RA.[2019]

Exercise prescription is essential in cardiac rehabilitation and should be tailored based on recent exercise tests that assess a patient's functional capacity and cardiac responses, ensuring safety and efficacy.

Clinicians play a crucial role in motivating patients to engage in exercise programs, emphasizing the importance of increasing physical activity for long-term health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise testing in cardiac rehabilitation. Exercise prescription and beyond. Williams, MA.[2019]

A systematic review of 422 older adults (average age 68.1 years) found that progressive resistance training (PRT), high-intensity interval training (HIIT), and their combination (COMB) significantly improved various cardiometabolic health markers compared to non-exercise controls, including reductions in body mass index and body fat percentage, and improvements in aerobic capacity, LDL cholesterol, and blood glucose levels.

While all exercise types showed benefits, further research is needed to determine the most effective exercise prescription for enhancing cardiometabolic health in older adults, particularly regarding HIIT and COMB training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance Training and High-intensity Interval Training Improve Cardiometabolic Health in High Risk Older Adults: A Systematic Review and Meta-anaylsis. McLeod, KA., Jones, MD., Thom, JM., et al.[2023]

A 12-week home-based telehealth exercise training program significantly increased physical activity levels and exercise capacity in patients with cardiometabolic multimorbidity, as shown by a randomized controlled trial involving 50 participants.

The program also improved health-related quality of life, particularly in physical function, indicating that telehealth exercise interventions can be effective and beneficial for patients managing multiple cardiometabolic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Home-Based Telehealth Exercise Training Program for Patients With Cardiometabolic Multimorbidity: A Randomized Controlled Trial. Chiang, SL., Shen, CL., Chen, LC., et al.[2021]

A systematic review of 11 studies involving 156 clinically stable patients with cardiometabolic diseases found that high-intensity interval exercise (HIIE) can lead to adverse responses in about 8% of individuals, indicating a higher risk compared to moderate-intensity exercise.

It is recommended that patients with cardiometabolic diseases who wish to engage in HIIE should be clinically stable, have prior experience with moderate-intensity exercise, and exercise under supervision to ensure safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Doesn't Kill You Makes You Fitter: A Systematic Review of High-Intensity Interval Exercise for Patients with Cardiovascular and Metabolic Diseases. Levinger, I., Shaw, CS., Stepto, NK., et al.[2022]

In a study of 192 obese patients undergoing a physical therapy and weight loss program, significant improvements were observed, including an average weight loss of 5.91 kg and a reduction in waist circumference by 7.1 cm, indicating effective weight management.

The program also led to enhanced exercise capacity (increased VO2ex by 5.29 ml/kg/min) and improved lower extremity function (LEFS increased by 9 points), along with reductions in blood pressure and fasting blood glucose, highlighting its positive impact on physical function and cardiometabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in cardiometabolic risk markers, aerobic fitness, and functional performance following a physical therapy weight loss program. Sabbahi, A., Arena, R., Woldt, J., et al.[2018]

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

A 12-week tele-exercise training program significantly improved physical activity levels and cardiorespiratory fitness in patients with cardiometabolic multimorbidity, with 68 out of 83 participants completing the study.

Participants in the tele-exercise group showed enhanced heart rate recovery and increased measures of fitness, such as VO2peak and workload, compared to those receiving usual care, indicating the program's effectiveness in managing cardiometabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a 12-week tele-exercise training program on cardiorespiratory fitness and heart rate recovery in patients with cardiometabolic multimorbidity. Chiang, SL., Shen, CL., Lee, MS., et al.[2023]

High levels of physical activity and exercise training are crucial for preventing and treating cardiovascular diseases, as supported by substantial evidence from various studies.

The review emphasizes the importance of prescribing exercise training to all patients, particularly those with cardiovascular conditions like coronary heart disease and heart failure, and recommends referrals to specialized cardiac rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and the cardiovascular system: clinical science and cardiovascular outcomes. Lavie, CJ., Arena, R., Swift, DL., et al.[2023]

Exercise therapy is beneficial for a wide range of diseases, including metabolic syndrome, heart and lung diseases, and even conditions like cancer and depression, improving symptoms and quality of life.

The review discusses how exercise can influence disease mechanisms and outlines guidelines for prescribing exercise, emphasizing the importance of tailored exercise types and amounts for different health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for prescribing exercise as therapy in chronic disease. Pedersen, BK., Saltin, B.[2022]

Regular exercise significantly increases markers of exercise capacity, such as VO2max and ventilatory threshold (VT), which can enhance overall quality of life, especially for patients with health limitations.

Exercise serves as a positive health recommendation that not only improves physical fitness but may also indirectly encourage patients to adopt healthier behaviors, contrasting with traditional negative health advice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise training prescriptions for patients. Foster, C., Cadwell, K., Crenshaw, B., et al.[2019]

A study involving 242 patients who underwent percutaneous coronary intervention showed that those receiving a positive-affect/self-affirmation (PA) intervention were significantly more likely to increase their physical activity by at least 336 kcal/week after 12 months compared to a standard patient education group (54.9% vs 37.4%).

The PA intervention group not only had a higher percentage of patients meeting the activity goal but also demonstrated nearly double the improvement in weekly kilocalorie expenditure (602 kcal vs 328 kcal), indicating that this behavioral intervention effectively promotes sustained physical activity post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of positive-affect induction to promote physical activity after percutaneous coronary intervention. Peterson, JC., Charlson, ME., Hoffman, Z., et al.[2021]

Citations

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Effectiveness of different intervention designs for improving ... Conclusions. Multi-component interventions were most effective at improving physical activity levels among people with cardiometabolic ...

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Exercise, Physical Activity, and Cardiometabolic Health Regular PA and exercise lead to numerous cardiovascular health benefits, including a reduction in ASCVD risk factors and events, cardiometabolic disease, HF, ...

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Effects of a workplace exercise intervention on ... However, the intervention group showed promising within-group improvements in specific cardio-metabolic factors, and maintained increased PA ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2807665

Effects of an Exercise Program on Cardiometabolic and ... A 20-week exercise program including aerobic plus resistance training improved body composition, cardiorespiratory fitness, and cardiometabolic risk factors.

6. who.int who.int/news-room/fact-sheets/detail/physical-activity

Physical activity WHO fact sheet on physical activity provides key facts and information on benefits, risks of inactivity, reasons for physical inactivity and ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.125.325526

Epidemiology and Cardiovascular Benefits of Physical ... In this review, we focus on the beneficial effects of routine physical activity (PA) on the cardiovascular system, the different ways we can achieve and ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2667368125000348

Effect and safety of a physical exercise-based intervention ... This study aimed to investigate the effect and safety of a 6-month high-intensity physical exercise-based intervention on body composition and cardiometabolic ...