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

Trial Summary

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.

What data supports the effectiveness of the treatment Exercise Intervention for Cardiometabolic Health?

Research shows that exercise training can improve markers of exercise capacity, which is linked to better quality of life, especially for those with limited exercise capacity due to health issues. Additionally, exercise therapy has been shown to improve cardiometabolic risk factors and overall health outcomes in patients with cardiometabolic conditions. ^{1 2 3 4 5}

Is exercise intervention generally safe for humans?

Exercise interventions are generally safe for humans, with few serious adverse events reported. Minor issues, like muscle injuries, can occur, especially in sedentary or older individuals, but starting slowly and gradually increasing intensity helps minimize risks. High-intensity exercise may have a slightly higher risk, so it should be done with caution and under supervision, especially for those with heart or metabolic conditions. ^{6 7 8 9 10}

How does the exercise intervention treatment differ from other treatments for cardiometabolic health?

The exercise intervention treatment is unique because it focuses on improving cardiometabolic health through physical activity, which can enhance body composition, aerobic capacity, and blood glucose levels without the use of medication. Unlike traditional drug treatments, this approach leverages the body's natural responses to exercise, offering a non-invasive and holistic way to manage cardiometabolic conditions. ^{5 11 12 13 14}

What is the purpose of this trial?

The goal of this study is to understand the interaction between the circadian system and physical activity. Participants will: * complete 2 inpatient stays * perform moderate exercise * be provided with identical meals * have frequent blood draws * provide urine and saliva samples

Research Team

Jingyi Qian, PhD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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

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

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

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

Exclusion Criteria

Any known contraindication to exercise testing based on current ACSM guidelines

Currently pregnant or breastfeeding

History of drug or alcohol dependency

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Improvements in cardiometabolic risk markers, aerobic fitness, and functional performance following a physical therapy weight loss program. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation. An overview. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Physical activity and exercise training prescriptions for patients. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a Home-Based Telehealth Exercise Training Program for Patients With Cardiometabolic Multimorbidity: A Randomized Controlled Trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of positive-affect induction to promote physical activity after percutaneous coronary intervention. [2021]

10. United States 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. [2015]

11. Germany 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. [2023]

12. United States 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. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Exercise and the cardiovascular system: clinical science and cardiovascular outcomes. [2023]

14. Denmark pubmed.ncbi.nlm.nih.gov

Evidence for prescribing exercise as therapy in chronic disease. [2022]