Effects of Physical Exercise on Sarcopenia After Bariatric Surgery

Study Overview
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Brief Summary
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The study will include 60 patients awaiting bariatric surgery. They will be randomized into 2 groups, experimental and control. The intervention will take place 1 month after surgery, for a total of 16 weeks. Parameters of body composition, metabolic risk, quality of life, physical activity and sedentary behavior will be determined

Detailed Description
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Bariatric surgery is the treatment of severe obesity with associated pathologies, with proven evidence in its benefits. Treating overweight allows a better and even reversal of pathologies associated with obesity. In this context, we know that physical exercise is important in the process of weight loss, however, and especially in bariatric surgery, the characteristics of physical activity are not consensual, as well as the effect of programs and physical exercise in this population. Weight loss associated with bariatric surgery is greatly associated with a significant reduction of skeletal muscle and bone mineral mass, which leads us to induce that after bariatric surgery, patients incur an increased risk of sarcopenia. The need for prophylactic programs that prevent sarcopenia in bariatric surgery patients seems to be one of the crucial points for the framing of long-term surgical success of bariatric and metabolic surgery. This randomized clinical trial will aim to study the effects of a 16-week supervised exercise intervention program on the prevention of sarcopenia after bariatric surgery This randomized controlled trial study will include 60 patients of both sexes on the waiting list for bariatric surgery and who have subsequently performed the surgery. They will be randomized into 2 groups, experimental and control. The intervention will take place 1 month after surgery, for a total of 16 weeks. Parameters of body composition, metabolic risk, quality of life, physical activity, and sedentary behavior will be determined. Assessments will take place in five moments, the surgery, the intervention, the post-intervention, six months after the intervention, twelve months after the intervention.

Official Title
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Effects of Physical Exercise on Sarcopenia After Bariatric Surgery: Protocol of a Randomized Controlled Study

Conditions
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Sarcopenic Obesity, Bariatric Surgery Candidate

Intervention / Treatment
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* Behavioral: EXPOBAR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: As inclusion criteria, patients should be enrolled for bariatric surgery at the hospital Aged between 18 years and 60 years Contraindication to the practice of exercise Agree to participate in the study Exclusion Criteria: Patients with problems in locomotion Surgical complications Psychiatric diseases and neurological disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>The duration of the program is 16-weeks, 3-times a week, for up to 50 minutes per session, starting 1 month after surgery, based on the recommendations of the WHO and the ACSM, because the guidelines for morbidly obese patients undergoing bariatric surgery are not defined. Information on exercises for morbidly obese adults is limited, so the exercise programs will follow the guidelines for adults aged 18 to 65 years healthy, with chronic diseases or disabilities | Behavioral: EXPOBAR<br>* Each session will start with 5 minutes of warm-up and finalization with 10 minutes of a cool-down, with work of flexibility and proprioception. The maintenance of balance and postural stability may be compromised in obese individuals, depending on the degree of obesity, although the support base provided by the position of the foot is proportional to the structural morphology of each subject. Flexibility is also gradually impaired in obese individuals and of course, these changes may be related to postural changes aggravated by a sedentary lifestyle and biological aging itself alongside all metabolic alterations inherent to the pathology of obesity (Benetti et al., 2016). And the warm-up and the cool-down will be developed as the component of training with the evolution by phases, both in time and in intensity. The first phase will include 20 minutes of interval training, encompassing circuit strength training. Each phase will have an increment of 10 minutes in the central block.<br>|
| No Intervention: Control Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Weight evaluation will be done using a scale | 1 year | 
| Height | Height evaluation will be done using a stadiometer | 1 year | 
| Abdominal circumference | Abdominal circumference will be determined by a measuring tape | 1 year | 
| HDL cholesterol in mg/dl | Blood sample | 1 year | 
| LDL cholesterol in mg/dl | Blood sample | 1 year | 
| Triglycerides in mg/dl | Blood sample | 1 year | 
| Glucose in mg/dl | Blood sample | 1 year | 
| Insulin in µIU/mL | Blood sample | 1 year | 
| Glycated hemoglobin in % | Blood sample | 1 year | 
| Alcohol intake | assessment of daily consumption through clinical data questionnaire | 1 year | 
| Mean blood pressure | Evaluation with Sphygnomanonetro | 1 year | 
| Concentration of ghrelin in pg/mg | blood ghrelin and leptin measurement | 1 year | 
| Concentration of leptin in pg/mg | blood ghrelin and leptin measurement | 1 year | 
| Lower limbs muscle strength | Lower limbs muscle strength will be evaluated with Biodex | 1 year | 
| Upper limbs muscle strength | The muscle strength of the upper limbs will be evaluated by manual pressure dynamometry (Handgrip) | 1 year | 
| Cardiorespiratory fitness | 6-minute walk test (TC6) | 1 year | 
| Cardiorespiratory | Sit-to-stand test for 30 seconds | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life Quality | Questionary BAROS as a self-report measure, validated for the Portuguese population specific for bariatric surgery | 1 year | 
| Salivary amylase | Saliva harvest | 1 year | 
| physical activity level | Accelerometers measure body movement, providing objective information about the frequency, intensity and duration of physical activity | 1 year | 
| Glycemia Variation in mg/dl | Evaluation continues through an implantable device for 5 days | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, quality of life, metabolic risk factors,, fat-free mass, sarcopenia, exercise