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| Name | Class |
|---|---|
| Research Foundation Flanders | OTHER |
| Wuhan Third Hospital | OTHER |
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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.
The added exercise intervention is initiated in line with the following readiness criteria, which were checked prior to each training session:
Criteria:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Standard of care treatment: - including passive / assisted / active movements, stretching, functional exercise, scar treatment Duration: 6-12 weeks |
|
| Exercise | Experimental | Standard of care + added exercises Exercise type: resistance and aerobic exercise Resistance Exercise: 3x / week (manual resistance, free weights, machines) Aerobic exercise: 2x / week (cycle ergometer, treadmill) Duration: 6-12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | Resistance and aerobic exercise in addition to standard of care rehabilitation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quadriceps muscle layer thickness (QMLT) | 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 | Baseline - 12 weeks |
| Change in rectus femoris cross sectional area (RF-CSA) | 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. | Baseline - 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin resistance | Method: HOMA-2 calculated by fasting plasma glucose and insulin, analysed by Western Blot Chemiluminescence | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Interleukin-1 | Western Blot Chemiluminescence | Baseline and 12 weeks |
| Change in Interleukin-6 | Western Blot Chemiluminescence | Baseline and 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David R Schieffelers | Contact | +32465419848 | david.schieffelers@uantwerp.be |
| Name | Affiliation | Role |
|---|---|---|
| Ulrike Van Daele | Faculty of Medicine and Health Sciences, University of Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Burns, Wuhan Third Hospital & Tongren Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430060 | China |
Datasets will be made available upon request.
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| ID | Term |
|---|---|
| D002056 | Burns |
| D009133 | Muscular Atrophy |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Randomized Controlled Trial
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Analysis of the primary outcome is carried out blind.
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| Standard of Care |
| Other |
Standard of care rehabilitation |
|
| Change in Tumor Necrosis Factor alpha (TNF-α) | Western Blot Chemiluminescence | Baseline and 12 weeks |
| Change in C-reactive protein | Western Blot Chemiluminescence | Baseline and 12 weeks |
| Change in Insulin like growth factor 1 (IGF-1) | Western Blot Chemiluminescence | Baseline and 12 weeks |
| Change in Glucagon | ELISA kits DGCG0, R&D Systems, Inc, USA | Baseline and 12 weeks |
| Change in Myostatin | ELISA kits DGDF80, R&D Systems, Inc, USA | Baseline and 12 weeks |
| Change in isometric peak force (knee extension) | 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 | Baseline and 12 weeks |
| Change in isometric peak force (hip flexion) | 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 | Baseline and 12 weeks |
| Change in isometric peak force (hip extension) | 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 | Baseline and 12 weeks |
| Change in hand grip strength | Method: Baseline LITE hydraulic dynamometer Analysis: Best of 3 trials | Baseline and 12 weeks |
| Change in Burn Specific Health Scale-Brief (BSHS-B) | 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) | Baseline and 12 weeks |
| Change in EQ-5D-5L | 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
| Baseline and 12 weeks |
| Number of adverse events | Recording of complications during exercise: Graft take, Wound infections, Medical, Cardio-respiratory safety | Baseline and 12 weeks |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |