Research of Sarcopenia in Patients After Bariatric-metabolic Surgery - the Effect of Programmed Aerobic and Power Exercising on the Functionality, Volume and Morphology of Muscle Tissue
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- muscle strength by Timed Up and Go test (in s)
研究概览
简要总结
The investigators' study published in 2020 (Pekar, M. et al.: The risk of sarcopenia 24 months after bariatric surgery - assessment by dual energy X-ray absorptiometry (DEXA): a prospective study; Videosurgery Miniinv 2020; https://doi.org/10.5114/wiitm.2020.93463) shows that patients are at risk of sar-copenia after bariatric-metabolic (BM) surgery. BM surgery leads to significant changes in body composition. Significant fat loss is followed by unwanted muscle loss. The study shows that the lack of physical activity is typical for these patients. To the algorithm of postoperative care the investigators plan to include controlled exercise programs for these patients. The investigators do not know what the complexity and time required to keep patients in good condition and reduce the risk of sarcopenia is. The investigators want to find the adequate amount of physical activity while maintaining long-term compliance of these patients.
详细描述
Obesity is an important medical problem. The number of obese individuals is increasing continuously in response to various environmental and genetic factors. For some morbidly obese patients, surgery is the only effective type of therapy. Despite bariatric surgery having good outcomes in terms of weight loss, it is associated with some adverse effects: several studies have reported subsequent alterations in bone and muscle metabolism, patients are getting in risk of sarcopenia. Of the surgical techniques available (laparoscopic gastric banding, Roux-en-Y bypass, biliopancreatic diversion), laparoscopic sleeve gastrectomy (LSG) is currently the technique of choice. This type of surgery leads to significant changes in body composition. Significant fat loss is followed by unwanted muscle loss. To the algorithm of postoperative care the investigators plan to include controlled exercise programs for these patients. The investigators do not know what the complexity and time required to keep patients in good condition and reduce the risk of sarcopenia is. The investigators want to find the adequate amount of physical activity while maintaining long-term compliance of these patients.
The study has been designed as a prospective randomized study, which is in conformity with the principles and guidelines of the Helsinki Declaration, good clinical practice and will be approved by the Ethical Committee of the Hospital AGEL Ostrava-Vitkovice, Czech Republic.
Potential study participants will undergo an initial examination at the clinical department of the surgical department specializing in obesity. In addition to professional surgical and internal examination, the potential patient will be examined by a clinical psychologist for the ability to participate in this type of study for a long time. Informed consent will be provided to selected study participants.
50 patients who undergo surgery will be randomized in two cohorts:
- Cohort 1: obese patients with LSG: 25 patients with controlled aerobic / anaerobic activity
- Cohort 2: obese LSG patients 25 patients without controlled physical activity
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index 30-50 kg/m2
- •ability to understand informed consent
- •signed informed consent
- •patient's residence within 100 km from Ostrava Czech Republic
排除标准
- •History of gastric surgery
- •acute gastric ulcers or inflammation
- •Type 1 Diabetes mellitus
- •celiac disease
- •history of malignity
- •previous bariatric-metabolic surgery or endoscopic obesity treatment,
- •specific genetic and humoral diseases connected to obesity (Prader-Willi syndrome, mutation of melanocortin receptor 4, etc.)
- •history of knee surgery
- •non MRI compatible patients' devices and implants
- •severe hematological diseases
- •acute or chronic pancreatitis
- •cirrhosis
- •severe psychiatric diseases
- •uncontrolled hypertense
- •immunological diseases
- •long-term corticoid therapy
- •uncontrolled thyroid diseases
- •renal insufficiency
- •alcohol abuse
结局指标
主要结局
muscle strength by Timed Up and Go test (in s)
时间窗: 24 months
lower values in this physical performance test mean better result
changes of lean mass by DXA measures (in kg/m2)
时间窗: 24 months
higher values mean better result
fat infiltration of muscles by MRI (in %)
时间窗: 24 months
lower content of fat means better result
muscle strength by walk test (in m)
时间窗: 24 months
higher values in this physical performance test mean better result
muscle strength by handgrip dynamometer (in kg)
时间窗: 24 months
higher values in this physical performance test mean better result
thickness of cartilage surface of the knee by MRI (in mm)
时间窗: 24 months
higher values mean better result
次要结局
- changes of fat mass by DXA measures (in kg/m2)(24 months)