Influence of Illusory Movements on Metabolism in Patients With Large Burns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Anticatabolic effect
研究概览
简要总结
Background. Large burns are the cause of extensive skeletal muscle devastation. The possibilities of rehabilitation of such patients are very limited, which contributes to the risk of metabolic failure and long-term musculoskeletal disorders. Illusory movements are a relatively new method of physiotherapy, which through functional proprioceptive stimulation enables the integration and networking of muscle units and has a neurotrophic effect on the cerebral cortex. In our pilot study, we demonstrated that illusory movements significantly increased basal energy expenditure in extensively burned patients in a catabolic state and with healing impairment in the later stage of burn disease. However, the metabolic effects of illusory movements have not yet been studied.
Tested hypotheses. 1. The use of illusory movements is suitable for the rehabilitation of patients with burns on 20% or more of the total body surface area (TBSA) in the early phase of the burn disease. 2. The use of illusory movements in these patients attenuates the extent of muscle catabolism.
Method. Pragmatic crossover study. Twenty patients with burns on 20% or more of the body surface area will be divided into two groups. They will be rehabilitated early or delayed by illusory movements for 14 days. Among other things, the following metabolic parameters will be monitored: nitrogen balance, basal and resting energy expenditure (BMR, REE), insulin resistance (IR), myokinins levels, muscle mitochondrial function and their morphology, and ultrasound cross-sectional diameter of the rectus femoris muscle. The control group will consist of ten healthy volunteers, in whom resting energy expenditure before and after using illusory movements exercise will be measured.
详细描述
The goal of this project is to find out whether illusory movements are suitable for patients in the early phase of burn disease, and how they influence patients' metabolism.
We are going to test these hypotheses:
- The use of illusory movements is suitable for patients with burns of 20 % TBSA and more in the early acute phase of the burn disease.
- The use of illusory movements reduces the extent of muscle catabolism in patients with large burns.
Way of solution This is a pragmatic cross-over study in patients with burns of 20 % TBSA or more in the early acute phase of the burn disease, who are expected to be hospitalized for 35 days or more. Patients meeting the inclusion criteria will be divided into two groups, A (n = 10) and B (n = 10). Group C will consist of healthy volunteers (n = 10).
The study will start after patient's basic cardiopulmonary stabilization, which usually corresponds to days 3-5 after the injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 and older;
- •Consent to be included in the study;
- •Burns II. - III. grade on 20 % TBSA and more;
- •Admission within 72 hours of the accident;
- •Expected hospital stay of 35 days or more.
排除标准
- •Age <18 years;
- •Refusal of the study in any point;
- •Unlikely patient survival (Revised Baux Index> 120);
- •Known primary neuromuscular diseases or spinal cord lesions;
- •Limb amputation before or during the study;
- •Bed rest before admission;
- •Pregnancy;
- •External fixator or surface metal implant on the limbs;
- •Known malignancy or history of malignancy treatment in the last 5 years;
- •History of HIV or AIDS;
- •Concomitant treatment with systemic corticosteroids;
- •Pacemaker, implanted defibrillator, or another bio-electronic device;
- •Patient in prison.
研究组 & 干预措施
Early Illusory Movements
Phase 1: A patient enrolled in group A will have standard rehabilitation according to the instructions of the attending surgeon and performed by an independent physiotherapist from the start of the study (Day 1), and also FPS performed by a study nurse will take place for 30 minutes twice a day, 2 hours or more after the end of standard rehabilitation, for 14 days (Day 15).
Phase 2: From Day 16 onwards, the patient will undergo standard rehabilitation only according to the instructions of the attending surgeon and performed by an independent physiotherapist for 14 days (Day 30).
干预措施: Functional Proprioceptive Stimulation (Device)
Deferred Illusory Movements
Phase 1: A patient enrolled in group B will have standard rehabilitation according to the instructions of the attending surgeon and performed by an independent physiotherapist, from the start of the study (Day 1) for 14 days (Day 15).
Phase 2: Then, from Day 16 onwards, in addition to standard physiotherapy, FPS performed by a study nurse will take place for 30 minutes twice a day, 2 hours or more after the end of standard rehabilitation, for 14 days (Day 30).
干预措施: Functional Proprioceptive Stimulation (Device)
结局指标
主要结局
Anticatabolic effect
时间窗: 2 years
The use of illusory movements changes the extent of muscle catabolism in patients with large burns.
Energy expenditure
时间窗: 2 years
The use of illusory movements changes energy expenditure in patients with large burns.
次要结局
- Insulin resistance(2 years)
- Mitochondrial functions(2 years)
研究者
Bohumil Bakalar MD
The Head of ITU, Prague Burn Center, 3rd Medical School, Prague
Charles University, Czech Republic