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?

The purpose of this research study is to study the effects of endurance exercise training on adipose (fat) tissue quality and insulin sensitivity in men and women.

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.

Is endurance exercise safe for people with obesity?

Endurance exercise, also known as aerobic or cardiovascular exercise, is generally considered safe for people with obesity. Studies show it can improve metabolic health, such as lowering blood sugar levels, without significant safety concerns. ^{1 2 3 4 5}

How does endurance exercise as a treatment for obesity differ from other treatments?

Endurance exercise, like aerobic or cardiovascular exercise, is unique because it not only helps with weight loss but also improves heart and muscle health, increases metabolism, and enhances glucose regulation. Unlike some treatments that focus solely on diet or medication, endurance exercise offers a holistic approach by improving overall fitness and reducing risks associated with obesity-related conditions. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Endurance Exercise, Aerobic Exercise, Cardiovascular Exercise for obesity?

Research shows that aerobic exercise can improve quality of life and physical performance in people with obesity. It also helps with weight loss, reduces body fat, and improves heart health, even if the weight loss is modest. ^{8 9 10 11 12}

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: Control (CTRL) group Active Control 6 Interventions

Group II: Endurance exercise (EX) 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

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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

Effect of aerobic exercise intensity on health-related quality of life in severe obesity: a randomized controlled trial. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Physical activity in management of persons with obesity. [2021]

3. Switzerland 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. [2023]

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

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

5. Finland pubmed.ncbi.nlm.nih.gov

More exercise for the obese? [2006]

6. Singapore 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. [2023]

7. Brazil pubmed.ncbi.nlm.nih.gov

Physical exercise and morbid obesity: a systematic review. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Eight sessions of endurance training decrease fasting glucose and improve glucose tolerance in middle-aged overweight males. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of exercise prescription for hypertensive obese men by ventilatory threshold. [2019]

10. New Zealand 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. [2022]

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

Special ergometric techniques and weight reduction. [2013]

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

Exercise physiology and cardiovascular fitness. [2008]