Clinical trial NCT05085015: Effects of Exercise Training in Individuals Undergoing Bariatric Surgery
Official title: Effects of Exercise Training on Cardiometabolic Risk Factors and Functional Capacity in Individuals Undergoing Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Bariatrics
Obesity
Bariatric Surgery
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The subject of the research; Effects of exercise training on cardiometabolic risk factors and functional capacity in individuals undergoing bariatric surgery.

Purpose of the research; Cardiometabolic risk factors, body composition, muscle strength and endurance, posture, foot sense, physical exercise capacity, balance, pain, exercise benefits - barriers, exercise self-efficacy, exercise beliefs, to evaluate the effects on body esteem, body image and quality of life.

Method of Research:

Post-surgical interventions are important in individuals who have undergone bariatric surgery. Intervention programs that include exercise, encourage the change in the lifestyle of individuals, effectively and accurately reduce post-surgical obesity. Functional Exercise Training, which can also be used for obesity treatment, consists of stretching, aerobics, strengthening and balance training. Therefore, it has a positive effect on body systems. In addition, Home Exercise Training can be used within the scope of obesity treatment. Exercise is one of the alternative methods by providing the adaptation of the individual to the exercise. Socio-demographic and physical characteristics of individuals will be recorded. Laboratory tests will be ordered for cardiometabolic risk factors. Body composition will be determined by Tanita brand body analysis monitor (MC-780MA). Posture will be evaluated by photogrammetry technique. Muscle strength assessment will be evaluated by leg, back and hand dynamometer instrument, muscle endurance tests, sensory assessment by foot sense assessment, physical capacity with physical exercise capacity tests, balance static and dynamic balance tests and pain questionnaire. Exercise benefits-barriers will be assessed by Exercise Benefits Barriers Scale, exercise self-efficacy by Exercise Self-Efficacy Scale. Exercise beliefs will also be questioned with a questionnaire. Self-esteem will be evaluated for all groups before and after treatment. The self respect will be evaluated by using the Rosenberg Self-Esteem Scale, body image with the Body Image Scale, with the quality of life using the Obesity-Specific Quality of Life Scale.The training will be carried out 3 days a week for 8 weeks, approximately 1 hour. Sufficient number of assessments and exercises will be used for individuals to become familiar with the equipment and training protocol.

Detailed description: Obesity is defined as abnormal or excessive fat accumulation in the body to the extent that it disrupts health. The prevalence of obesity is increasing day by day in developed and developing countries. While 600 million of the world population were obese in 2014, this situation reached 700 million in 2015, and when the trend continues in the same way, it is thought that more than 3 billion people will have overweight or obesity in 2030. Therefore, the worldwide prevalence of morbid obesity will increase rapidly. Obesity is a risk factor especially for cardiovascular disease and causes an increase in mortality and morbidity with the central accumulation of adipose tissues. It affects the muscle, liver, subcutaneous and intra-abdominal regions, especially due to intraabdominal and / or visceral fat. As a result, cardiometabolic complications occur, as it causes physical inactivity, muscle strength and endurance are affected, posture is affected, physical performance is affected, self-esteem, body image, health-related quality of life and exercise avoidance occur. It has been reported that approximately 91% of obese individuals complain of musculoskeletal pain, 69% of them have back pain and 58% have knee pain.

When the literature is examined, it is seen that conservative therapies such as nutrition, exercise and drug management are used intensively in the treatment of obesity, more invasive methods are more prominent today and bariatric surgery is preferred by many people. Studies emphasize that non-surgical methods fail to achieve permanent success compared to surgical methods. Obese individuals undergoing bariatric surgery have reported a large diet history that failed to stop weight gain, starting in adolescence. It has been reported that obese individuals experience higher levels of symptoms such as stress, anxiety, depression, food cravings and psychological effects such as lower self-esteem compared to normal weight individuals, and this situation continuously increases weight gain. For this reason, bariatric surgery has become increasingly common in the fight for effective weight loss. The postoperative process in which exercise and lifestyle changes are adopted after bariatric surgery is important. With the prominence of bariatric surgery in the studies performed, if weight loss management is not planned well after surgery, weight gain and complications occur after surgery, and it is seen that the effect of the surgery performed decreases. Weight recovery in this population also increases the likelihood of the return of obesity-related comorbidities. Insufficient physical activity and inadequate nutritional support after surgery cause sarcopenia. Therefore, it is an important anabolic stimulant for the prevention of muscle protein synthesis and sarcopenia formation, together with adequate nutritional support, together with early physical activity after surgery.

Increasing physical activity, exercise and lifestyle changes are important in maintaining the weight given during the postoperative period, reducing muscle loss and increasing fat burning. The purposes of exercise training given in the post-surgery period in obese individuals are to increase body fat mass loss, protect muscle mass, and improve physical and mental health. Although there are studies in which exercise training is important following bariatric surgery, there is insufficient evidence regarding the interventions of different exercise protocols. Finding the best exercise protocols, increasing body fat mass loss and preserving muscle mass is important as part of the post-surgical guideline. Studies have reported that physical exercise is a positive predictor of outcome after bariatric surgery. Intervention programs that include exercise are reported to effectively reduce obesity and comorbidity by encouraging individuals to change their lifestyle after such surgery. Studies have shown that exercise is considered an effective mediator for correcting insulin resistance, effectively reduces indicators of obesity such as body mass index (BMI) and body fat percentage, and reduced risk factors for cardiovascular diseases. Therefore, the main purpose of the study is to evaluate the effects of exercise training on cardiometabolic risk factors and functional capacity in individuals who have undergone bariatric surgery. There is no such exercise protocol study conducted in Cyprus. The investigators are of the opinion that the research is an interesting study in this respect.

Functional Exercise Training is a type of exercise that includes training for stretching, aerobics, strengthening and balance. Studies on obese individuals have reported a positive effect on body composition, functional capacity and quality of life.

Home Exercise Training, on the other hand, is one of the alternative methods of exercise that maximizes the sustainability of behavioral change by providing adaptation to exercise throughout life. It is an option that will increase an individual's physical activity compliance.

Evidence regarding the effectiveness of Functional Exercise Training and Home Exercise Training in Individuals Undergoing Bariatric Surgery is insufficient and it is necessary to know and clarify the differences create. It is necessary to clarify whether individuals continue the exercise in their daily lives and whether the continuity of the effects of the exercise should be addressed. In this context, the content and effects of the exercise programs to be applied to individuals who have undergone bariatric surgery are important in Cyprus for future multifactorial situations and may guide individuals.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 20-60 years,
* Those who have passed 1 month to 2 years after the operation,
* Lack of a regular exercise program for the last 6 months (3 and 20 minutes per week.

Exclusion Criteria:

* Uncontrollable Hypertension (systolic≥160, diastolic≤90 mmHg), Diabetes, Cancer and Cardiovascular Disease
* Those who have orthopedic, neurological or mental illnesses that prevent them from exercising
* Previous bariatric surgery
* Use of drugs that will affect body composition that will cause weight or energy expenditure
* Having vision, hearing and communication problems

Primary outcomes:
measure: Insulin Resistance
timeFrame: change from baseline at 8 weeks after the intervention
Secondary outcomes:
measure: Body Analysis Monitor
timeFrame: change from baseline at 8 weeks after the intervention
measure: Waist and hip circumference
timeFrame: change from baseline at 8 weeks after the intervention
measure: Muscle Strength
timeFrame: change from baseline at 8 weeks after the intervention
measure: Sorensen Test
timeFrame: change from baseline at 8 weeks after the intervention
measure: Trunk Flexor Muscle Endurance Test
timeFrame: change from baseline at 8 weeks after the intervention
measure: Side Bridge Test (bilateral)
timeFrame: change from baseline at 8 weeks after the intervention
measure: Squat Test
timeFrame: change from baseline at 8 weeks after the intervention
measure: Posture Analysis
timeFrame: change from baseline at 8 weeks after the intervention
measure: Foot Sense Assessment
timeFrame: change from baseline at 8 weeks after the intervention
measure: Time Up & Go Test
timeFrame: change from baseline at 8 weeks after the intervention
measure: Chair Sit & Go Test
timeFrame: change from baseline at 8 weeks after the intervention
measure: Normal walking speed
timeFrame: change from baseline at 8 weeks after the intervention
measure: Fast walking speed
timeFrame: change from baseline at 8 weeks after the intervention
measure: One Foot Stand Test
timeFrame: change from baseline at 8 weeks after the intervention
measure: Total physical capacity score
timeFrame: change from baseline at 8 weeks after the intervention
measure: Balance
timeFrame: change from baseline at 8 weeks after the intervention
measure: Short-Form Mcgill Pain Questionnaire
timeFrame: change from baseline at 8 weeks after the intervention
measure: Visual Analog Scale
timeFrame: change from baseline at 8 weeks after the intervention
measure: Exercise Benefits Barriers
timeFrame: change from baseline at 8 weeks after the intervention
measure: Exercise Self-Efficacy
timeFrame: change from baseline at 8 weeks after the intervention
measure: Exercise Beliefs
timeFrame: change from baseline at 8 weeks after the intervention
measure: Self respect
timeFrame: change from baseline at 8 weeks after the intervention
measure: Body Image
timeFrame: change from baseline at 8 weeks after the intervention
measure: Life quality
timeFrame: change from baseline at 8 weeks after the intervention
measure: Functional Exercise Capacity
timeFrame: change from baseline at 8 weeks after the intervention
measure: Lipid Profile
timeFrame: change from baseline at 8 weeks after the intervention
measure: İnsulin Resistance
timeFrame: change from baseline at 8 weeks after the intervention
measure: Body weight
timeFrame: change from baseline at 8 weeks after the intervention
measure: Height
timeFrame: change from baseline at 8 weeks after the intervention
measure: Body mass index
timeFrame: change from baseline at 8 weeks after the intervention
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Hayriye Tomaç
Study officials:
References: