Exercise Intervention for Cardiometabolic Health
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Brigham and Women's Hospital
Disqualifiers: Smoking, Pregnancy, Psychiatric illness, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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
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.
12345Is 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.
678910How 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.
511121314Eligibility 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
+1 more
Exclusion Criteria
Any known contraindication to exercise testing based on current ACSM guidelines
Currently pregnant or breastfeeding
History of drug or alcohol dependency
+4 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Exercise B-A InterventionExperimental Treatment1 Intervention
The Exercise B first, then the Exercise A intervention.
Group II: Exercise A-B InterventionExperimental Treatment1 Intervention
The Exercise A first, then the Exercise B intervention.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brigham and Women's HospitalBoston, MA
Jingyi QianBoston, MA
Loading ...
Who Is Running the Clinical Trial?
Brigham and Women's HospitalLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Improvements in cardiometabolic risk markers, aerobic fitness, and functional performance following a physical therapy weight loss program. [2018]The objectives of this study were to determine the efficacy of a current physical therapy and weight loss program model on exercise performance, physical function, and cardiometabolic risk factors in obese patients.
Cardiac rehabilitation. An overview. [2019]The paper is intended to acquaint physical therapists with the theory and practice of cardiac rehabilitation, which is often prescribed for patients who have coronary heart disease, and the therapists' responsibilities in this effort. The related exercise physiology literature is reviewed, and physiological, psychological, physical, and prognostic advantages of cardiac rehabilitation are described. Cardiac rehabilitation is presented in three phases: acute care, outpatient, and further conditioning programs. The protocols for exercise testing and programs of progressive activity are discussed, with emphasis upon the role of physical therapists. Data collected at Tufts New England Medical Center demonstrating the measurable effects of cardiovascular training for patients with coronary heart disease ar presented.
Physical activity and exercise training prescriptions for patients. [2019]The dominant outcome from exercise prescription is an increase in various markers of exercise capacity. A very large group of studies have demonstrated that the VO2max is increased in response to exercise performed according to well-accepted principles of exercise prescription. Other markers of exercise capacity, such as the VT, also improve substantially following exercise training. Finally, improvement in exercise capacity is generally related to improved quality of life, particularly in patients with exercise capacity limited by various disease processes. Beyond the specific physiologic gains from training, exercise contributes to a better overall clinical outcome. Although there are few data conclusively demonstrating that exercise independently causes favorable changes in other risk factors, it should be recognized that exercise can contribute indirectly to modulation of other risk factors. Exercise represents positive health advice. Since most of our other recommendations to patients are in the nature of negative advice (e.g., don't smoke, don't eat high-fat foods), and since people are infamous for ignoring negative advice, the value of using a positive recommendation that may indirectly lead the patient to discontinue bad behaviors can hardly be overstated.
Exercise testing in cardiac rehabilitation. Exercise prescription and beyond. [2019]The prescription of exercise, either as a part of a formal exercise training program or as a means to increase physical activity in general, has been and will remain a primary component of cardiac rehabilitation and secondary prevention programming. Wherever possible, this prescription should be based on a recent exercise test that documents the cardiac patient's functional capacity, cardiac and hemodynamic responses to exercise, and signs and symptoms associated with exertion. Clearly the prescription of exercise and suggestions for increasing levels of physical activity must be based on accepted principles of exercise physiology and expected training responses. Nonetheless, the art of exercise prescription should guarantee flexible methodologies to meet the specific needs of each individual patient. Although the patient must accept ultimate responsibility for participation, the clinician bears the burden of continually attempting to reinforce the importance of increasing caloric expenditure and motivating patients to initiate and commit to long-term participation in a safe and appropriately designed program of exercise and increasing physical activity.
Effectiveness of a Home-Based Telehealth Exercise Training Program for Patients With Cardiometabolic Multimorbidity: A Randomized Controlled Trial. [2021]Exercise training has positive effects on the management of cardiometabolic conditions. Little is known about the effectiveness of home-based telehealth exercise training programs among patients with cardiometabolic multimorbidity, which is associated with functional decline and decreased health-related quality of life.
Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]For high-risk individuals and their healthcare providers, finding the right balance between promoting physical activity and minimizing the risk of adverse events can be difficult. More information on the prevalence and influence of adverse events is needed to improve providers' ability to prescribe effective and safe exercise programs for their patients.
Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]Researchers who conduct physical activity (PA) intervention studies provide an invaluable opportunity to further the prevention science knowledge base for implementing and delivering PA programs. Despite recommendations that screening is important to increase patient safety, the specific screening criteria best suited for different community applications are unknown. To add to the limited knowledge base, we examined the screening procedures and the occurrence of adverse events among more than 5,500 participants from 11 diverse PA interventions participating in a trans-National Institutes of Health (NIH) collaborative known as the Behavior Change Consortium (BCC). Numerous adverse events occur in sedentary, chronically ill, or older populations, although few are attributed to activity/exercise interventions. No serious study-related adverse events (SRAEs) were reported across different screening practices, interventions, and/or populations. Relatively few minor SRAEs were reported (primarily musculoskeletal injuries), emphasizing the need to be aware of potential musculoskeletal sequelae during exercise interventions. One common characteristic of these studies is that they recommended "start low and go slow" strategies, with moderate intensity PA as the goal behavior. Recommendations to reframe the meaning and use of screening criteria to initiate PA in the community are discussed. Although we were unable to conduct generalizable quantitative analyses from our data, the combined experience of the BCC studies provides a unique opportunity to examine PA-related screening and safety issues across diverse populations, settings, and intervention programs.
What Doesn't Kill You Makes You Fitter: A Systematic Review of High-Intensity Interval Exercise for Patients with Cardiovascular and Metabolic Diseases. [2022]High-intensity interval exercise (HIIE) has gained popularity in recent years for patients with cardiovascular and metabolic diseases. Despite potential benefits, concerns remain about the safety of the acute response (during and/or within 24 hours postexercise) to a single session of HIIE for these cohorts. Therefore, the aim of this study was to perform a systematic review to evaluate the safety of acute HIIE for people with cardiometabolic diseases. Electronic databases were searched for studies published prior to January 2015, which reported the acute responses of patients with cardiometabolic diseases to HIIE (≥80% peak power output or ≥85% peak aerobic power, VO2peak). Eleven studies met the inclusion criteria (n = 156; clinically stable, aged 27-66 years), with 13 adverse responses reported (~8% of individuals). The rate of adverse responses is somewhat higher compared to the previously reported risk during moderate-intensity exercise. Caution must be taken when prescribing HIIE to patients with cardiometabolic disease. Patients who wish to perform HIIE should be clinically stable, have had recent exposure to at least regular moderate-intensity exercise, and have appropriate supervision and monitoring during and after the exercise session.
A randomized controlled trial of positive-affect induction to promote physical activity after percutaneous coronary intervention. [2021]Within 1 year after percutaneous coronary intervention, more than 20% of patients experience new adverse events. Physical activity confers a 25% reduction in mortality; however, physical activity is widely underused. Thus, there is a need for more powerful behavioral interventions to promote physical activity. Our objective was to motivate patients to achieve an increase in expenditure of 336 kcal/wk or more at 12 months as assessed by the Paffenbarger Physical Activity and Exercise Index.
Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. [2015]To present detailed adverse event (AE) data from a randomized controlled trial (RCT) of a home-based exercise program delivered to an elderly high-risk population by an exercise therapist after medical clearance from a general practitioner (GP).
Resistance Training and High-intensity Interval Training Improve Cardiometabolic Health in High Risk Older Adults: A Systematic Review and Meta-anaylsis. [2023]Progressive resistance training (PRT) and high-intensity interval training (HIIT) improve cardiometabolic health in older adults. Whether combination PRT+HIIT (COMB) provides similar or additional benefit is less clear. This systematic review with meta-analysis of controlled trials examined effects of PRT, HIIT and COMB compared to non-exercise control in older adults with high cardiometabolic risk. Databases were searched until January 2021, with study quality assessed using the PEDro scale. Risk factor data was extracted and analysed using RevMan V.5.3. We analysed 422 participants from nine studies (7 PRT, n=149, 1 HIIT, n=10, 1 COMB, n=60; control n=203; mean age 68.1±1.4 years). Compared to control, exercise improved body mass index (mean difference (MD) -0.33 [-0.47, -0.20], p≤0.0001), body fat% (standardised mean difference (SMD) -0.71 [-1.34, -0.08], p=0.03), aerobic capacity (SMD 0.41 [0.05, 0.78], p=0.03), low-density lipoprotein (SMD -0.27 [-0.52, -0.01], p=0.04), and blood glucose (SMD -0.31 [-0.58, -0.05], p=0.02). Therefore, PRT, HIIT and COMB can improve cardiometabolic health in older adults with cardiometabolic risk. Further research is warranted, particularly in HIIT and COMB, to identify the optimal exercise prescription, if any, for improving older adults cardiometabolic health. (PROSPERO: CRD42019128527).
Effectiveness of a 12-week tele-exercise training program on cardiorespiratory fitness and heart rate recovery in patients with cardiometabolic multimorbidity. [2023]Exercise has positive impacts on cardiometabolic health. However, evidence regarding the effectiveness of tele-exercise training on cardiorespiratory fitness and heart rate recovery in patients with cardiometabolic multimorbidity remains limited.
Exercise and the cardiovascular system: clinical science and cardiovascular outcomes. [2023]Substantial evidence has established the value of high levels of physical activity, exercise training (ET), and overall cardiorespiratory fitness in the prevention and treatment of cardiovascular diseases. This article reviews some basics of exercise physiology and the acute and chronic responses of ET, as well as the effect of physical activity and cardiorespiratory fitness on cardiovascular diseases. This review also surveys data from epidemiological and ET studies in the primary and secondary prevention of cardiovascular diseases, particularly coronary heart disease and heart failure. These data strongly support the routine prescription of ET to all patients and referrals for patients with cardiovascular diseases, especially coronary heart disease and heart failure, to specific cardiac rehabilitation and ET programs.
Evidence for prescribing exercise as therapy in chronic disease. [2022]Considerable knowledge has accumulated in recent decades concerning the significance of physical activity in the treatment of a number of diseases, including diseases that do not primarily manifest as disorders of the locomotive apparatus. In this review we present the evidence for prescribing exercise therapy in the treatment of metabolic syndrome-related disorders (insulin resistance, type 2 diabetes, dyslipidemia, hypertension, obesity), heart and pulmonary diseases (chronic obstructive pulmonary disease, coronary heart disease, chronic heart failure, intermittent claudication), muscle, bone and joint diseases (osteoarthritis, rheumatoid arthritis, osteoporosis, fibromyalgia, chronic fatigue syndrome) and cancer, depression, asthma and type 1 diabetes. For each disease, we review the effect of exercise therapy on disease pathogenesis, on symptoms specific to the diagnosis, on physical fitness or strength and on quality of life. The possible mechanisms of action are briefly examined and the principles for prescribing exercise therapy are discussed, focusing on the type and amount of exercise and possible contraindications.