Endurance Exercise for Obesity

(ATLAS Trial)

Recruiting at 1 trial location

Overseen By Recruitment Department

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: AdventHealth Translational Research Institute

Must not be taking: Beta blockers, Anticoagulants, Antipsychotics, others

Disqualifiers: Diabetes, Hypertension, Cardiovascular conditions, 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: Unknown

Duration: 12 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how regular endurance exercise (also known as aerobic or cardiovascular exercise) can improve fat tissue quality and the body's insulin response, which affects blood sugar levels. Participants will either join an exercise program or be in a control group for comparison. The trial seeks men and pre-menopausal women living with obesity, with a BMI between 30 and 40, who have not exercised regularly more than once a week over the past year. The study aims to better understand how exercise impacts health, potentially offering new insights for managing obesity. As an unphased trial, it provides participants the chance to contribute to groundbreaking research that could lead to new strategies for managing obesity.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but certain medications are exclusionary, such as those for cardiovascular, psychiatric, pulmonary, hormonal, and other conditions. If you are on any of these medications, you may not be eligible to participate.

What prior data suggests that endurance exercise is safe for improving adipose tissue quality and insulin sensitivity?

Research has shown that endurance exercise is generally very safe for most people. Studies have found that regular aerobic exercise, such as endurance workouts, offers significant health benefits, including improved heart health and reduced body fat. For example, engaging in at least 150 minutes of aerobic exercise each week can help reduce waist size and lower body fat.

Research also suggests that endurance exercise boosts overall heart and blood vessel health, helping them remain strong with age. Additionally, it can enhance the function of mitochondria, the tiny structures in cells that produce energy.

The sources provided do not indicate specific evidence of harm from endurance exercise, and it is generally well-tolerated. However, as with any activity, it's important to pay attention to the body's signals and consult a healthcare professional before starting a new exercise program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about endurance exercise for obesity because it offers a natural and accessible way to tackle the condition without relying on medications or surgical interventions. Unlike medications that may come with side effects or require long-term use, endurance exercise improves cardiovascular health and increases metabolism by boosting the body's ability to burn fat. Moreover, this approach empowers individuals to adopt a healthier lifestyle, potentially leading to sustainable weight management and overall well-being.

What evidence suggests that endurance exercise is effective for obesity?

This trial will compare the effects of endurance exercise with a control group. Studies have shown that regular endurance exercise can greatly improve health in people with obesity. Research indicates that aerobic exercise, such as endurance training, helps reduce waist size and body fat. Evidence also shows that it improves the body's insulin use, which is crucial for controlling blood sugar levels. Endurance exercise is linked to numerous health benefits, including a healthier heart and a lower risk of obesity-related diseases, such as type 2 diabetes. Overall, endurance exercise is a proven method to enhance fat burning and insulin use in the body. ^{1 2 6 7 8}

Who Is on the Research Team?

Lauren Sparks, PhD

Principal Investigator

AdventHealth Translational Research Institute

Ursula White, PhD

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

This trial is for men and pre-menopausal women aged 18-45 with obesity (BMI of 30.0-40.0), leading a sedentary lifestyle, who haven't had significant weight or lifestyle changes recently. Participants must understand English, agree to use birth control if applicable, and commit to the study's procedures.

Inclusion Criteria

BMI 30.0-40.0 kg/m2

For women not using pharmaceutical contraception, must agree to use specified birth control methods

Sedentary lifestyle defined as minimal exercise in the past year

Exclusion Criteria

Unstable body weight in the last 3 months

Significant changes in diet or physical activity in the last 3 months

Weight >396 lb (180 kg)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endurance exercise training or control (no exercise) for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Endurance Exercise

Trial Overview

The study investigates how endurance exercise affects fat tissue quality and insulin sensitivity in obese individuals. It involves muscle and fat biopsies, heavy water labeling, glucose clamp tests, monitoring physical activity/dietary habits using an accelerometer.

How Is the Trial Designed?

Group I: Endurance exercise (EX) group Active Control 6 Interventions

Group II: Control (CTRL) group Active Control 6 Interventions

Who Is Running the Clinical Trial?

AdventHealth Translational Research Institute

Lead Sponsor

Trials

51

Recruited

5,900+

Pennington Biomedical Research Center

Collaborator

Trials

314

Recruited

183,000+

Published Research Related to This Trial

A systematic review of 13 studies found that both aerobic and strength exercises are crucial for effectively treating individuals with morbid obesity, whether they are undergoing medical or surgical interventions.

It is essential to tailor the volume and intensity of exercise programs to ensure patient adherence, highlighting the need for individualized exercise plans for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise and morbid obesity: a systematic review. Fonseca-Junior, SJ., Sá, CG., Rodrigues, PA., et al.[2019]

In a study of 27 inactive men with obesity over 12 weeks, resistance exercise (RE) significantly reduced fat mass by 4.39% and increased lean mass by 2.12%, while also improving muscle strength and cardiorespiratory capacity without changing overall body weight.

Aerobic exercise (AE) also decreased fat mass by 5.91% and improved cardiorespiratory capacity by 19.07%, but did not affect lean mass or muscle strength, suggesting that RE may be more effective for building muscle and strength in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influences of Resistance versus Aerobic Exercise on Physiological and Physical Fitness Changes in Previously Inactive Men with Obesity: A Prospective, Single-Blinded Randomized Controlled Trial. Kim, B., Kim, S.[2022]

A high-fat diet (HFD) and muscle-specific FOXO gene suppression led to significant impairments in skeletal and heart muscle function in Drosophila, including reduced endurance and structural damage, highlighting the negative impact of obesity on muscle health.

Endurance exercise (EE) and overexpression of the FOXO gene were effective in preventing the detrimental effects of HFD on muscle function and structure, suggesting that enhancing FOXO-related antioxidant pathways and lipid metabolism can protect against obesity-induced muscle damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Muscle FOXO-Specific Overexpression and Endurance Exercise Protect Skeletal Muscle and Heart from Defects Caused by a High-Fat Diet in Young Drosophila. Jin, JH., Wen, DT., Chen, YL., et al.[2023]

Exercise has numerous benefits for individuals with obesity, including aiding in weight loss and improving cardiovascular health, but the direct impact on weight loss from exercise alone is modest, typically resulting in only a few kilograms of weight loss.

Physical activity is crucial for managing type 2 diabetes and preventing its complications, and a structured approach like the 5 A's strategy can help healthcare professionals effectively support patients in overcoming barriers to increasing their physical activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity in management of persons with obesity. Oppert, JM., Bellicha, A., Ciangura, C.[2021]

A structured, home-based exercise program significantly improved physical performance and quality of life in patients with obesity, as demonstrated by a cohort of 151 participants over a 3-month period.

After the program, participants showed notable enhancements in walking distance, speed, and VO2max, indicating that even simple exercise routines can have substantial health benefits for individuals with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of an Easy, Structured, and Home-Based Exercise Program to Improve Physical Performance and Quality of Life in a Patient's Cohort with Obesity. López-López, CO., Montes Castillo, ML., Aguilar-Serralde, CA., et al.[2023]

A systematic review of 12 randomized controlled trials found that moderate-intensity physical exercise alone is not sufficient for significant weight loss in overweight and obese adults; it should be combined with diet and behavior modification for better results.

The combination of exercise, diet, and behavior therapy not only leads to the best weight loss outcomes but also helps prevent further weight gain and maintain a lower body weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity, diet and behaviour modification in the treatment of overweight and obese adults: a systematic review. Södlerlund, A., Fischer, A., Johansson, T.[2018]

Exercise training can provide significant physiological and psychological benefits for obese individuals, but it's crucial to tailor the exercise intensity, frequency, and duration to maximize these benefits.

Aquatic exercise is particularly advantageous for obese individuals due to the buoyancy and thermal properties of water, making activities like swimming, cycling, and aerobic dance more accessible and comfortable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Special ergometric techniques and weight reduction. Sheldahl, LM.[2013]

In a study involving 73 patients with severe obesity, both moderate-intensity continuous training (MICT) and a combined high-intensity interval training with MICT (HIIT/MICT) program led to significant improvements in health-related quality of life (HRQOL) after 24 weeks, with no significant difference between the two exercise intensities.

Both exercise programs resulted in moderate improvements in various quality of life measures, indicating that the benefits of exercise on health may not depend on the intensity of the workout.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of aerobic exercise intensity on health-related quality of life in severe obesity: a randomized controlled trial. Berge, J., Hjelmesæth, J., Kolotkin, RL., et al.[2022]

Eight endurance training sessions over 3 weeks significantly reduced fasting glucose levels in sedentary middle-aged males with overweight or obesity, indicating improved metabolic regulation.

The training, which involved 60 minutes of indoor cycling at about 83% of peak heart rate, also enhanced glucose tolerance and plasma lipids, making it a beneficial exercise recommendation for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eight sessions of endurance training decrease fasting glucose and improve glucose tolerance in middle-aged overweight males. Jelstad, S., Ditta Valsdottir, T., Johansen, EI., et al.[2021]

Endurance exercise training leads to significant metabolic adaptations, such as increased mitochondrial size and number in skeletal muscles, improved fatty acid oxidation, and higher glycogen storage, enhancing overall energy production.

Cardiovascular benefits include lower resting heart rates, increased stroke volume, and improved VO2max, which collectively reduce the risk of coronary artery disease and improve overall cardiovascular fitness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise physiology and cardiovascular fitness. Braun, LT.[2008]

Increased physical activity, particularly moderate-intensity aerobic exercise, can improve metabolic health in obese individuals by increasing good cholesterol (HDL) and lowering bad cholesterol (VLDL), insulin levels, and blood pressure.

A multifactorial approach that combines exercise, nutrition education, and behavior modification is essential for effective weight management and long-term adherence to healthy lifestyle changes in individuals with mild to moderate obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

More exercise for the obese? Kukkonen-Harjula, K.[2006]

Obese males with mild hypertension showed significantly lower exercise capacity, measured by VO2 and work rate, compared to control subjects, indicating a need for tailored exercise prescriptions.

A one-year follow-up study demonstrated that low-intensity aerobic exercise improved both body composition and resting blood pressure in obese individuals, regardless of hypertension status, suggesting that even moderate exercise can have beneficial health effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of exercise prescription for hypertensive obese men by ventilatory threshold. Miyatake, N., Nishikawa, H., Morishita, A., et al.[2019]

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