跳至主要内容
临床试验/NCT05289219
NCT05289219Unknown不适用

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

University of Évora2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年9月1日最近更新:
适应症
干预措施

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

Experimental

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

No Intervention

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

发起方
University of Évora
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cláudia Amaro dos Santos

Principal Investigator

University of Évora

研究点 (2)

Loading locations...

相似试验