Overseen ByRobert C Hickner, PhD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?Impaired endothelial function is observed in disease states related to obesity, such as atherosclerosis, coronary artery disease, and diabetes. Reactive oxygen species (ROS) production and resultant oxidative stress contribute to the development of these obesity-related diseases. The enzyme NADPH-oxidase is a major source of oxidative stress within the vasculature, and has been linked with the Metabolic Syndrome. In the investigator's previously funded studies, the investigators demonstrated for the first time that: 1) in vivo ROS were elevated in skeletal muscle of obese as compared to lean or overweight human subjects, 2) perfusion of the NADPH-oxidase inhibitor apocynin locally into muscle normalized ROS levels and reversed local microvascular endothelial dysfunction in the obese individuals, and 3) aerobic exercise training was effective at attenuating in vivo hydrogen peroxide production and reversing microvascular endothelial dysfunction in the obese individuals. The investigators will investigate in this R15 renewal application the mechanism of exercise training-induced alterations in ROS production and action on endothelial dysfunction in obesity using our newly developed microdialysis methodology of monitoring ROS production, in combination with analysis of muscle biopsy samples obtained before and after our previously tested 8-week intervention of aerobic interval exercise training. The objectives of this study are to determine the impact of in vivo NADPH oxidase activity on endothelial function in obese individuals, and to determine the mechanism of training-induced improvements in endothelial function. The investigator's unique microdialysis methodology will allow monitoring of microvascular/endothelial function and ROS generation, as well as the administration of pharmacological agents directly into muscle. The central hypothesis is that it is upregulation of both mitochondrial ROS and NADPH oxidase-derived ROS that results in endothelial dysfunction in obesity, and that exercise training down-regulates mitochondrial-derived ROS, and NADPH oxidase 4, thereby improving endothelial function. The aims of this proposal are to: 1) determine the contributions of mitochondrial ROS and specific NADPH oxidase isoforms to the NADPH oxidase dependent endothelial dysfunction in skeletal muscle of obese individuals; 2) determine the mechanism of ROS reduction and improved endothelial function resulting from an 8-week aerobic interval training program.
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 data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for obesity?
Research shows that exercise helps people with obesity by improving physical performance, quality of life, and reducing body weight and fat mass. It also enhances cardiovascular health and helps maintain muscle strength during weight loss.
12345Is exercise safe for people with obesity?
Exercise is generally safe for people with obesity and offers many health benefits, such as improved cardiovascular health and better weight management. However, it's important to tailor the type and intensity of exercise to individual needs and consult with healthcare professionals to ensure safety.
12678How does exercise as a treatment for obesity differ from other treatments?
Exercise for obesity is unique because it not only helps with weight and fat loss but also improves overall fitness and health, even if weight loss is modest. Unlike other treatments, exercise can enhance cardiovascular health, increase muscle strength, and improve quality of life, making it an essential part of managing obesity.
126910Eligibility Criteria
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.
+3 more
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
+11 more
Trial Timeline
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)
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Exercise trainingExperimental Treatment1 Intervention
Eight weeks of interval exercise training
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Florida State UniversityTallahassee, FL
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Who Is Running the Clinical Trial?
Florida State UniversityLead Sponsor
References
Physical activity in management of persons with obesity. [2021]Physical activity and exercise have many benefits in persons with obesity, helping with weight loss, body fat loss, abdominal visceral fat loss and possibly with weight maintenance after weight loss. The effect of exercise training (endurance or endurance plus resistance or high-intensity interval training) alone on weight loss as outcome appears relatively modest, amounting to only a few kg. However, endurance training during weight loss has been shown to increase V̇O2max and resistance training during weight loss leads to lower loss in lean body mass and increased muscle strength. In addition, higher physical activity levels improve cardiovascular risk, whatever weight variations. Specifically, physical activity or exercise is part of lifestyle measures for prevention of type 2 diabetes and substantially helps with metabolic control in patients with type 2 diabetes. The importance of physical activity counselling and exercise prescription in the management strategy will depend on specific treatment objectives as defined for a given patient, including weight loss, prevention of weigh regain, prevention of cardio-metabolic comorbidities, lean body mass preservation but also improvement in quality of life or development of social links. The 5 A's strategy consisting in: Ask, Assess, Advise, Agree, Assist (or Arrange) appears well adapted in this setting. Professionals need to be aware of the many barriers patients with obesity may meet on their way to increase habitual physical activity as specific solutions should be proposed. A major challenge is how to improve adherence to new physical activity habits over time.
Effects of physical training on anthropometrics, physical and physiological capacities in individuals with obesity: A systematic review. [2021]Increasing the amount of physical activity is an important strategy for weight loss. This systematic review summarizes recent findings on the effects of physical training on anthropometric characteristics, physical performances and physiological capacities in individuals with overweight and obesity. A systematic literature search strategy was conducted from inception until June 2019 using four electronic databases that identified 2,708 records. After screening for titles, abstracts and full texts, 116 studies were included in our final analysis. Both aerobic (e.g., endurance training) and anaerobic training (e.g., high-intensity training, resistance training) improved body composition and physical fitness indicators in adults, adolescents and children with obesity (effect size: 0.08 < d < 2.67, trivial to very large). This systematic review suggests that both low- and high-intensity training significantly reduced body weight and fat mass while increasing fat-free mass in individuals with obesity (effect size: 0.04 <d <3.2, trivial to very large). A significant increase in VO2max also occurs in individuals with obesity in response to aerobic training or high-intensity interval training (effect size: 0.13 < d < 6.24, trivial to very large). Further studies are needed to define the optimal combination of training intensity and duration needed to produce the most efficacious results in individuals with obesity.
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]The benefits of exercise in patients with obesity are clear; physical performance and quality of life improve after exercise programs in patients with obesity. Our aim was to evaluate the usefulness of an easy, structured, and home-based exercise program to improve physical performance and quality-of-life in patients with obesity.
[Physical activity in the treatment of obesity]. [2010]Physical activity is a pivotal component in the treatment of obesity. An increase in energy expenditure through physical activity in combination with a weight reduction diet intensifies negative energy balance, brings a reduction in fat reserves and, simultaneously, prevents loss of an active body mass. The main aim and significance of physical activity in obese individuals is not the weight reduction itself but its positive effects on factors that represent an increased cardiovascular risk. When prescribing a physical activity to an obese individual, selection of a suitable form, intensity, duration and frequency of load should all be considered. Patient cooperation represents an essential factor in the success of a therapy involving physical activity and is concurrently affected by the presence of other obesity complicating diseases. Also important are other negative factors determined by real life: lack of time, lack of support from family and others, bad weather, inaccessibility of suitable equipment or space or aversion to physical activity as such. When these circumstances are overcome, positively motivating reasoning has to be provided. Communication between physicians and non-medical professional community is the only way to influence physical activity of obese patients and minimise adverse effects. Significant increase in physical activity of the entire population is determined by modifications in physical and social environment and revision of healthcare policy.
PHYSICAL ACTIVITY, QUALITY OF LIFE AND BODY IMAGE OF CANDIDATES TO BARIATRIC SURGERY. [2019]Physical activity enhances quality of life and body image in obese. Behavioural changes are useful tools to increase life conditions of this population.
Physical exercise and morbid obesity: a systematic review. [2019]Physical exercise is an important component for the treatment of obesity. Little information is available about the best and safety form of physical exercise concerning the type and volume-intensity to be prescribed for individuals with morbid obesity.
Obesity and physical exercise. [2021]Obesity represents a major health problem worldwide and is associated with increased prevalence of numerous health-related conditions, including diabetes, hypertension, cardiovascular disease, some forms of cancer and musculoskeletal disorders, among others. Studies that have examined the impact of physical exercise combined with energy restriction diets on weight have shown greater weight loss compared to interventions of exercise-only. Accordingly, the most effective approach to achieve significant weight loss includes a combination of diet, exercise and behavioral strategies. Current guidelines recommend participating in at least 150 minutes of moderate-intensity or 75 minutes of vigorous intensity aerobic exercise weekly, and resistance/muscle strengthening training, involving all major muscle groups at least twice a week. For patients seeking to maintain weight loss, high levels of exercise (225-420 min/week of moderate intensity exercise) have been associated with improved weight maintenance compared to lower levels (
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. [2018]Clinical practice guidelines globally recommend lifestyle modification including diet and exercise training as first-line treatment for obesity. The clinical benefits of exercise training in adults with obesity is well-documented; however, there is no strong evidence for the effectiveness of exercise training for weight loss in class II and class III obesity. The purpose of the randomised controlled trial described in this protocol article is to examine the effect of exercise training, in addition to a very low energy diet (VLED), in clinically severe obese women for changes in body composition, physical function, quality of life, and markers of cardiometabolic risk.
Effect of exercise on obesity. [2019]The changes in fitness and body composition which accompany physical training in people of normal weight would be very valuable in the treatment of obesity. However, one of the most marked disabilities arising from obesity is a reduced exercise tolerance, so severely obese patients are unable to perform the exercise which would bring these benefits. It has been suggested that exercise may confer benefits on the obese person by reducing voluntary food intake, or by causing a prolonged elevation of metabolic rate. There is no good evidence for these claims. Obesity is best treated by a combination of dietary restriction and exercise: the more severe the obesity the more important the diet component of treatment, but exercise becomes more important with the management of mild obesity or the prevention of obesity.
Exercise in the management of obesity. [2019]Obesity is a multifactorial disease with increasing incidence and burden on societies worldwide. Obesity can be managed through everyday behavioral changes involving energy intake and energy expenditure. Concerning the latter, there is strong evidence that regular exercise contributes to body weight and fat loss, maintenance of body weight and fat reduction, and metabolic fitness in obesity. Appropriate exercise programs should ideally combine large negative energy balance, long-term adherence, and beneficial effects on health and well-being. Endurance training appears to be the most effective in this respect, although resistance training and high-intensity interval training play distinct roles in the effectiveness of exercise interventions. With weight regain being so common, weight loss maintenance is probably the greatest challenge in the successful treatment of obesity. There is an established association between higher levels of physical activity and greater weight loss maintenance, based on the abundance of evidence from prospective observational studies and retrospective analyses. However, proving a causative relationship between exercise and weight loss maintenance is difficult at present. Exercise has the potential to alleviate the health consequences of obesity, even in the absence of weight loss. All in all, exercise constitutes an indispensable, yet often underestimated, tool in the management of obesity.