Effects of Physical Exercise on Sarcopenia After Bariatric Surgery: Protocol of a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Body weight
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Randomization is performed using a random selection method from the waiting list and the data will be coded and transferred to the database, depending on the intervention group and control group. Data analysis will be done statistically.
Each participant will be randomly assigned to each group after signing the informed consent and conducting the initial assessments. All laboratory samples and data collected will be identified with identification ID, safeguarding the confidentiality of the collected data.
At the end of this study, all participants of the control group will be offered the same intervention as the exercise group.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients with problems in locomotion
- •Surgical complications
- •Psychiatric diseases and neurological disorders
研究组 & 干预措施
Intervention Group
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
干预措施: EXPOBAR (Behavioral)
Control Group
结局指标
主要结局
Body weight
时间窗: 1 year
Weight evaluation will be done using a scale
Glycated hemoglobin in %
时间窗: 1 year
Blood sample
Lower limbs muscle strength
时间窗: 1 year
Lower limbs muscle strength will be evaluated with Biodex
HDL cholesterol in mg/dl
时间窗: 1 year
Blood sample
Mean blood pressure
时间窗: 1 year
Evaluation with Sphygnomanonetro
Cardiorespiratory
时间窗: 1 year
Sit-to-stand test for 30 seconds
LDL cholesterol in mg/dl
时间窗: 1 year
Blood sample
Insulin in µIU/mL
时间窗: 1 year
Blood sample
Alcohol intake
时间窗: 1 year
assessment of daily consumption through clinical data questionnaire
Concentration of ghrelin in pg/mg
时间窗: 1 year
blood ghrelin and leptin measurement
Concentration of leptin in pg/mg
时间窗: 1 year
blood ghrelin and leptin measurement
Triglycerides in mg/dl
时间窗: 1 year
Blood sample
Glucose in mg/dl
时间窗: 1 year
Blood sample
Cardiorespiratory fitness
时间窗: 1 year
6-minute walk test (TC6)
Height
时间窗: 1 year
Height evaluation will be done using a stadiometer
Abdominal circumference
时间窗: 1 year
Abdominal circumference will be determined by a measuring tape
Upper limbs muscle strength
时间窗: 1 year
The muscle strength of the upper limbs will be evaluated by manual pressure dynamometry (Handgrip)
次要结局
- Glycemia Variation in mg/dl(1 year)
- Life Quality(1 year)
- Salivary amylase(1 year)
- physical activity level(1 year)
研究者
Cláudia Amaro dos Santos
Principal Investigator
University of Évora
