Pathophysiological Mechanisms and Early Exercise Rehabilitation Counter Measures of Hypermetabolism and Muscle Wasting in Severe Burns.
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in quadriceps muscle layer thickness (QMLT)
研究概览
简要总结
BACKGROUND:
Postburn changes in glucose and protein metabolism are at their peak during the acute phase of severe burns. The resulting metabolic derangements lead to substantial muscle wasting, insulin resistance, which ultimately hampers full recovery and reintegration into society.
PURPOSE:
This randomized controlled trial was initiated to investigate the effects of exercise-based rehabilitation on muscle wasting, insulin resistance, and quality of life during the acute phase of severe adult burns.
METHODS:
Severly burned adults (40-80%TBSA) will be recruited from one of China's largest burn centres.
Subjects allocated to the intervention group will undergo a 6-12 week long exercise program in addition to standard care rehabilitation. As part of the exercise program, participants will carry out progressive resistance and aerobic training, initiated as soon as medical safety and patient cooperation allow. Exercise type and dosage will be chosen according to patient status in terms of grafts, mobility, and strength.
The control group will receive standard care rehabilitation only, including passive, assisted, active range of motion exercise, functional exercise, and scar treatment.
The results of this translational research will provide insight into the effects and mechanisms of exercise on both a fundamental and clinical spectrum.
详细描述
The added exercise intervention is initiated in line with the following readiness criteria, which were checked prior to each training session:
Criteria:
- Cardiorespiratory stability:
- Mean arterial pressure (MAP) 60 - 110 mmHg
- fraction of inspired oxygen (FiO2) <60%
- partial pressure of oxygen / fraction of inspired oxygen (PaO2/FiO2) >200
- Respiratory rate <40 bpm
- Positive end expiratory pressure (PEEP) <10 cmH2O
- no high inotropic doses (Dopamine >10 mcg/kg/min or Nor/adrenaline <0,1 mcg/kg/min)
- Temp. 36 - 38,5°C
- Richmond Agitation Sedation Scale (RASS) -2 - +2
- Medical Doctor clearance
- Medical research council (MRC) score lower limbs ≥3
Accordingly, the post burn starting time differs per enrolled subject.
Exercises are administered as in-bed exercises or out-of-bed exercises, depending on whether subjects are able and allowed to engage in out-of-bed mobility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Analysis of the primary outcome is carried out blind.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥40 - ≤70 %TBSA
- •Burn depth: 2nd deep / 3rd degree
排除标准
- •Electrical burn (except flash burns)
- •Associated injury: fracture lower limb
- •Diabetes Mellitus type 1
- •Central neurological/neuromuscular disorders (interfering with assessment/exercise)
- •Cognitive / psychological disorders (interfering with cooperation)
- •Cardiopulmonary disease (interfering with exercise safety)
- •Pregnancy
- •Palliative care
结局指标
主要结局
Change in quadriceps muscle layer thickness (QMLT)
时间窗: Baseline - 12 weeks
Method: B-mode ultrasound on the anterior aspect of the thigh. Technique: maximal and minimal pressure Location: measured at 1/2 and 2/3 of the distance between anterior superior iliac spine and the superior pole of the patella. Analysis: An average of 3 trials will be recorded and analyzed using dedicated software
Change in rectus femoris cross sectional area (RF-CSA)
时间窗: Baseline - 12 weeks
Method: B-mode ultrasound on the anterior aspect of the thigh. Technique: minimal pressure. Location: measured at the most proximal distance where the entire muscle belly is still visible on the ultrasound image. Analysis: An average of 3 trials will be recorded and analyzed using dedicated software.
次要结局
- Change in insulin resistance(Baseline and 12 weeks)
研究者
Ulrike Van Daele
Prof. dr.
Universiteit Antwerpen