Exercise for Obesity

Overseen By Robert C Hickner, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Must be taking: Estrogen/progestin contraceptives

Must not be taking: NSAIDs, SSRIs

Disqualifiers: Diabetes, Hypertension, Heart failure, 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: 7

Duration: 8 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how exercise can improve blood vessel function in individuals with obesity. Researchers focus on how exercise reduces oxidative stress and enhances blood vessel performance. Participants will engage in an 8-week aerobic interval exercise program to study these effects. This trial suits sedentary individuals with obesity who have maintained stable weight for six months and have metabolic syndrome, especially those not currently exercising regularly. As an unphased trial, it offers participants the chance to contribute to groundbreaking research on exercise and cardiovascular health.

Will I have to stop taking my current medications?

The trial requires that participants not take medications that affect circulation, nonsteroidal anti-inflammatory drugs, or serotonin reuptake inhibitors. If you are on these medications, you may need to stop taking them to participate.

What prior data suggests that this exercise training is safe for obese individuals?

Studies have shown that exercise is generally a safe and effective way to improve health, especially for people with obesity. Regular aerobic exercise, like that used in the trial, can help reduce body fat and enhance overall fitness. Research indicates that engaging in at least 150 minutes of aerobic exercise each week can lead to significant health benefits, such as weight loss and improved body composition.

Most people tolerate exercise well, and it is often recommended to enhance health and reduce the risk of diseases linked to obesity. Reports of problems related to exercise are rare when performed correctly. Starting slowly and gradually increasing intensity helps avoid injuries.

In summary, exercise is a safe option for most individuals seeking to improve their health, and the benefits can be substantial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard obesity treatments that often focus on diet changes or medication, this exercise training program is unique because it emphasizes interval exercise, which involves alternating between short bursts of intense activity and periods of rest or lower-intensity exercise. Researchers are excited about this approach because interval training can significantly boost metabolism and improve cardiovascular health more effectively than steady-state exercise. Additionally, this method can be more time-efficient, potentially making it easier for people to incorporate into their busy lives.

What evidence suggests that exercise might be an effective treatment for obesity?

Research shows that exercise, especially aerobic interval training, can improve health in people with obesity. Studies have found that performing at least 150 minutes of aerobic exercise each week can reduce waist size and lower body fat. This exercise also decreases harmful molecules called reactive oxygen species (ROS), which are linked to obesity-related diseases. Previous research suggests that exercise can enhance blood vessel health in obese individuals by reducing these harmful molecules. This trial will specifically evaluate the effects of eight weeks of interval exercise training, which includes short bursts of intense exercise, as a particularly effective and time-efficient approach for people with obesity. ^{1 3 5 6 7}

Who Is on the Research Team?

Robert C Hickner, PhD

Principal Investigator

Florida State University

Are You a Good Fit for This Trial?

This trial is for premenopausal women who are obese, sedentary, and have been weight stable for the last 6 months. They must meet at least three criteria of Metabolic Syndrome such as a large waist size or high blood pressure. Participants should not be taking certain medications or supplements that affect circulation or oxidative stress.

Inclusion Criteria

I am using a combined hormonal contraceptive method.

Sedentary obese individuals will have the Metabolic Syndrome as defined according to the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III)

I am a woman and have not gone through menopause.

Exclusion Criteria

I am on medication that could affect my blood flow.

I do not have conditions like severe arthritis, Parkinson's, or paralysis that would stop me from doing exercise tasks.

Individuals who smoke or chew tobacco

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Testing

Subjects undergo baseline testing including medical history, physical examination, and screening for cardiovascular disease and type 2 diabetes.

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo 8 weeks of aerobic interval exercise training, with microdialysis experiments conducted before and after the training period.

8 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for changes in muscle blood flow and reactive oxygen species levels after the exercise training.

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview The study tests how an 8-week aerobic interval exercise program affects obesity-related endothelial dysfunction by reducing oxidative stress in muscles. It explores the role of NADPH oxidase activity and mitochondrial ROS in improving vascular health through exercise.

How Is the Trial Designed?

Group I: Exercise training Experimental Treatment 1 Intervention

Eight weeks of interval exercise training

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Published Research Related to This Trial

In a 12-week study involving 38 obese patients, those receiving weekly encouragement from personal trainers showed significant improvements in physical activity levels, pain reduction, and overall health status compared to a control group.

While there was no significant change in body weight, the structured physical activity program led to enhanced quality of life for the participants, highlighting the importance of behavioral changes in managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PHYSICAL ACTIVITY, QUALITY OF LIFE AND BODY IMAGE OF CANDIDATES TO BARIATRIC SURGERY. Barreto, BLM., Lima, JS., Albuquerque, DB., et al.[2019]

A systematic review of 116 studies found that both aerobic and anaerobic training significantly improve body composition and physical fitness in individuals with obesity, with effect sizes ranging from trivial to very large.

Physical training not only reduces body weight and fat mass but also increases fat-free mass and VO2max, indicating enhanced cardiovascular fitness, suggesting that various intensities of exercise can be beneficial for weight loss and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of physical training on anthropometrics, physical and physiological capacities in individuals with obesity: A systematic review. Zouhal, H., Ben Abderrahman, A., Khodamoradi, A., et al.[2021]

Regular exercise is crucial for managing obesity, contributing to weight loss, maintenance, and improved metabolic health, with endurance training being the most effective type of exercise.

Higher levels of physical activity are associated with better weight loss maintenance, although establishing a direct cause-and-effect relationship remains challenging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in the management of obesity. Petridou, A., Siopi, A., Mougios, V.[2019]

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]

Exercise can be beneficial for obese individuals, but many are unable to tolerate physical activity due to their weight, which limits their ability to gain fitness and improve body composition.

The most effective treatment for obesity combines dietary restriction and exercise, with a greater emphasis on diet for those with severe obesity and a focus on exercise for managing mild obesity or preventing weight gain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of exercise on obesity. Garrow, JS.[2019]

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]

Physical activity is crucial for treating obesity, as it not only helps reduce fat but also prevents the loss of muscle mass and improves cardiovascular health, making it more than just a weight loss tool.

Successful physical activity programs for obese individuals require careful consideration of the type, intensity, duration, and frequency of exercise, along with addressing real-life barriers such as time constraints and lack of support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical activity in the treatment of obesity]. Svacinová, H., Matoulek, M.[2010]

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]

Combining physical exercise with energy restriction diets leads to greater weight loss than exercise alone, making it the most effective strategy for significant weight loss.

Engaging in at least 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic exercise weekly, along with resistance training, is recommended for weight loss and maintenance, which also helps improve obesity-related health issues like diabetes and cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity and physical exercise. Celik, O., Yildiz, BO.[2021]

This randomized controlled trial will assess the impact of exercise training combined with a very low energy diet (VLED) on body composition and health outcomes in 60 clinically severe obese women over 12 months.

The study aims to provide evidence on whether adding exercise to a VLED can lead to greater improvements in physical function, quality of life, and cardiometabolic risk factors compared to diet alone, addressing a gap in research for class II and III obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The functional and clinical outcomes of exercise training following a very low energy diet for severely obese women: study protocol for a randomised controlled trial. Miller, CT., Fraser, SF., Selig, SE., et al.[2018]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK539893/

Exercise and Fitness Effect on Obesity - StatPearls - NCBI - NIH Researchers have proposed that exercise is an important lifestyle measure to maintain a healthy weight. This review will cover the role of exercise in obesity ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828487

Aerobic Exercise and Weight Loss in Adults: A Systematic ... Aerobic exercise at least 150 minutes per week was associated with clinically important reductions in waist circumference and measures of body fat.

3. nature.com nature.com/articles/s41598-025-11076-w

Effects of resistance training and aerobic ... This study investigated the effectiveness of a resistance and aerobic training model among 71 middle-aged participants aged 30–60 (mean age ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.121.008243

Comparative Efficacy of 5 Exercise Types on ... Interval training, although intense, appears to be an effective and time-efficient exercise mode for individuals with overweight and obesity to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9285060/

Resistance training effectiveness on body composition and ... Interventions involving resistance training and caloric restriction were the most effective for reducing body fat percentage (ES = −3.8%, 95% CI: −4.7 to −2.9%, ...

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

Physical activity People who are insufficiently active have a 20% to 30% increased risk of death compared to people who are sufficiently active. Regular physical ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8365736/

Effect of exercise training on weight loss, body composition ... These findings show favorable effects of exercise training on weight loss and body composition changes in adults with overweight or obesity. Visceral fat loss ...