Burns
Conditions
Keywords
Burns, Exercise rehabilitation, Exercise Therapy, Muscle wasting, Hypermetabolism, Insulin resistance
Brief summary
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.
Detailed description
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. Exercise intensity for resistance training is set at 60% peak force based on a weekly peak force measurement by hand-held dynamometry, or on a 3 RM in case of out of bed exercises. Aerobic exercise intensity is set at 50-75% peak Watts determined by a weekly cycle ergometer or treadmill ramp protocol.
Interventions
OTHERExercise
Resistance and aerobic exercise in addition to standard of care rehabilitation
OTHERStandard of Care
Standard of care rehabilitation
Sponsors
Research Foundation Flanders
Wuhan Third Hospital
Universiteit Antwerpen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Analysis of the primary outcome is carried out blind.
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* ≥40 - ≤70 %TBSA * Burn depth: 2nd deep / 3rd degree
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in quadriceps muscle layer thickness (QMLT) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in insulin resistance | Baseline and 12 weeks | Method: HOMA-2 calculated by fasting plasma glucose and insulin, analysed by Western Blot Chemiluminescence |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in C-reactive protein | Baseline and 12 weeks | Western Blot Chemiluminescence |
| Change in Insulin like growth factor 1 (IGF-1) | Baseline and 12 weeks | Western Blot Chemiluminescence |
| Change in Glucagon | Baseline and 12 weeks | ELISA kits DGCG0, R&D Systems, Inc, USA |
| Change in Myostatin | Baseline and 12 weeks | ELISA kits DGDF80, R&D Systems, Inc, USA |
| Change in isometric peak force (knee extension) | Baseline and 12 weeks | Method: Hand-held dynamometry (Lafayette instrument Co. Europe, U.K.). Isometric peak fore is measured by a 'make' manoeuvre with a fixation band disallowing movement. Test position: Supine with a fixation band fixed to the hospital bed. Analysis: Best of 3 trials |
| Change in Interleukin-1 | Baseline and 12 weeks | Western Blot Chemiluminescence |
| Change in isometric peak force (hip extension) | Baseline and 12 weeks | Method: Hand-held dynamometry (Lafayette instrument Co. Europe, U.K.). Isometric peak fore is measured by a 'make' manoeuvre with a fixation band disallowing movement. Test position: Supine with a fixation band fixed to the hospital bed. Analysis: Best of 3 trials |
| Change in hand grip strength | Baseline and 12 weeks | Method: Baseline LITE hydraulic dynamometer Analysis: Best of 3 trials |
| Change in Burn Specific Health Scale-Brief (BSHS-B) | Baseline and 12 weeks | Burn-specific quality of life, measured by the Burn Specific Health Scale-Brief questionnaire (Mandarin Chinese version). Total score 152 (0 worst score, 152 best score), consisting of 6 subdomains: 1\) Body imagine (36 points) Simple abilities (36 points) Sexuality (24 points) Affect (32 points) Work (16 points) Interpersonal relationship (8 points) |
| Change in EQ-5D-5L | Baseline and 12 weeks | Overall quality of life, measured by EQ-5D-5L (Mandarin Chinese version) Total score: 25 points (0 worst score, 25 best score), consisting of 5 subdomains 1. Mobility (5 points) 2. Self-care (5 points) 3. Usual activities (5 points) 4. pain / discomfort (5 points) 5. Anxiety / Depression (5 points) EQ overall health assessed on a Visual Analogue Scale, Total 0-100 (0 worst, 100 best score) |
| Number of adverse events | Baseline and 12 weeks | Recording of complications during exercise: Graft take, Wound infections, Medical, Cardio-respiratory safety |
| Change in isometric peak force (hip flexion) | Baseline and 12 weeks | Method: Hand-held dynamometry (Lafayette instrument Co. Europe, U.K.). Isometric peak fore is measured by a 'make' manoeuvre with a fixation band disallowing movement. Test position: Supine with a fixation band fixed to the hospital bed. Analysis: Best of 3 trials |
| Change in Interleukin-6 | Baseline and 12 weeks | Western Blot Chemiluminescence |
| Change in Tumor Necrosis Factor alpha (TNF-α) | Baseline and 12 weeks | Western Blot Chemiluminescence |
Countries
China
Contacts
Primary ContactDavid R Schieffelers
Outcome results
None listed