NCT06337656尚未招募不适用
Influence of an Alternating Whole-Body Vibration Training on Muscle Mass and Muscle Strength in Patients With Liver Cirrhosis and Sarcopenia: A Clinical Pilot Project
University Hospital of Cologne0 个研究点目标入组 15 人开始时间: 2024年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- Evaluation of the Effectiveness on muscle mass
研究概览
简要总结
- Comprehensive Investigation of the Impact of Side-Alternating Whole-Body Vibration Training on Muscle Mass and Muscle Strength in Patients with Liver Cirrhosis and Sarcopenia
- Simultaneous Characterization and Evaluation of Dynamic Changes in Health-Related Quality of Life in our Patient Cohort with Liver Cirrhosis and Sarcopenia through Side-Alternating Whole-Body Vibration Training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with confirmed or newly diagnosed compensated liver cirrhosis suffering from sarcopenia (combined decrease in muscle mass and muscle strength)
- •The liver cirrhosis is in a compensated stage.
- •The following etiologies of chronic liver disease are present: chronic hepatitis B infection, chronic hepatitis C infection, alcoholic liver disease, autoimmune hepatitis, cholestatic liver disease (PBC, PSC), or other chronic hepatopathy.
- •Alcohol abstinence of at least 3 months in cases of alcohol-related liver disease.
- •Routine cancer screening for the presence of a liver tumor (HCC surveillance) is routinely performed using MRI or CT scans, as ultrasound assessment is severely limited.
- •Permission from the treating physician to engage in physical activity.
- •Signed informed consent form.
排除标准
- •Non-compliance with inclusion criteria
- •Patients with recent hospitalizations (within the last 3 months) due to gastrointestinal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis
- •Presence of inadequately treated portal hypertension
- •Known chronic liver disease not described in the above groups
- •Alcohol consumption >20 g per day
- •Excessive alcohol consumption during the study period leads to exclusion from the study
- •Substance abuse
- •Taking medications known to affect muscle mass or strength (e.g., Amiodarone, Chloroquine, Macrolides)
- •Taking medications known to cause movement disorders (e.g., Reserpine, Lithium, Cyclosporine A, Dopamine agonists)
- •Patients with unstable cardiovascular diseases: e.g., unstable angina pectoris, uncontrolled hypertension (≥ 160/100 mmHg), uncontrolled diabetes (blood sugar > 250 mg/dl), history of myocardial infarction or stroke
- •Patients with musculoskeletal deformities, symptomatic rheumatoid or osteoarthritis
- •Patients with untreated or newly diagnosed active malignant tumors in history
- •Patients with neuromuscular or neurodegenerative diseases
- •Patients with untreated hernias
- •Patients with symptomatic, known untreated aortic aneurysm, with recent hospitalizations (within the last 6 months)
- •Patients with fractures within the last 12 months
- •Participation in moderate-intensity training programs for more than 2 hours per week
- •Patients who have received chemotherapy at the time of the study or in the past 3 months
- •Other underlying conditions that contraindicate vibration training and/or functional performance tests
- •Circumstances preventing the individual from assessing the nature, scope, and possible consequences of the clinical trial
- •Signs indicating that the subject is likely not to adhere to the study protocol (e.g., lack of cooperation)
- •a. Definition of hepatic decompensation
- •Occurrence of symptomatic ascites, hepatic encephalopathy, portal hypertensive bleeding (e.g., esophageal variceal bleeding), infection
结局指标
主要结局
Evaluation of the Effectiveness on muscle mass
时间窗: 6 months
Evaluation of the Effectiveness on muscle mass through quantification of muscle mass by the skeletal muscle index (SMI) at the level of lumbar vertebral body 3 measured in MRI or CT.
Evaluation of the Effectiveness on muscle thickness
时间窗: 6 months
Evaluation of the Effectiveness on muscle mass through quantification of muscle mass by the transverse psoas muscle thickness (TPMT) at the level of lumbar vertebral body 3 measured in MRI or CT.
Evaluation of the Effectiveness on physical function
时间窗: 6 months
Evaluation of the Effectiveness on physical function by using the Liver-Frailty-Index
Evaluation of the Effectiveness on mobility, in particular the risk of falling
时间窗: 6 months
Evaluation of the Effectiveness on mobility, in particular the risk of falling by using the Tinetti test
Evaluation of the Effectiveness on muscle strength
时间窗: 6 months
Evaluation of the effectiveness of the intervention in terms of muscle strength using the hand-grip-strength
次要结局
- Evaluation of Safety of the Training Method(12 weeks)
- Health-Related Quality of Life(6 months)
研究者
Eva Dittmann
Principal Investigator
University Hospital of Cologne
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