- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04372550
Effects of Early Exercise Rehabilitation in Severe Burns
Pathophysiological Mechanisms and Early Exercise Rehabilitation Counter Measures of Hypermetabolism and Muscle Wasting in Severe Burns.
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.
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David R Schieffelers
- Phone Number: +32465419848
- Email: david.schieffelers@uantwerp.be
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430060
- Recruiting
- Institute of Burns, Wuhan Third Hospital & Tongren Hospital of Wuhan University
-
Contact:
- Xie Weiguo
- Phone Number: +8618071085225
- Email: wgxie@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard of Care
Standard of care treatment: - including passive / assisted / active movements, stretching, functional exercise, scar treatment Duration: 6-12 weeks |
Standard of care rehabilitation
|
Experimental: Exercise
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 |
Standard of care rehabilitation
Resistance and aerobic exercise in addition to standard of care rehabilitation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quadriceps muscle layer thickness (QMLT)
Time Frame: 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 |
Baseline - 12 weeks
|
Change in rectus femoris cross sectional area (RF-CSA)
Time Frame: 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. |
Baseline - 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in insulin resistance
Time Frame: Baseline and 12 weeks
|
Method: HOMA-2 calculated by fasting plasma glucose and insulin, analysed by Western Blot Chemiluminescence
|
Baseline and 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Interleukin-1
Time Frame: Baseline and 12 weeks
|
Western Blot Chemiluminescence
|
Baseline and 12 weeks
|
Change in Interleukin-6
Time Frame: Baseline and 12 weeks
|
Western Blot Chemiluminescence
|
Baseline and 12 weeks
|
Change in Tumor Necrosis Factor alpha (TNF-α)
Time Frame: Baseline and 12 weeks
|
Western Blot Chemiluminescence
|
Baseline and 12 weeks
|
Change in C-reactive protein
Time Frame: Baseline and 12 weeks
|
Western Blot Chemiluminescence
|
Baseline and 12 weeks
|
Change in Insulin like growth factor 1 (IGF-1)
Time Frame: Baseline and 12 weeks
|
Western Blot Chemiluminescence
|
Baseline and 12 weeks
|
Change in Glucagon
Time Frame: Baseline and 12 weeks
|
ELISA kits DGCG0, R&D Systems, Inc, USA
|
Baseline and 12 weeks
|
Change in Myostatin
Time Frame: Baseline and 12 weeks
|
ELISA kits DGDF80, R&D Systems, Inc, USA
|
Baseline and 12 weeks
|
Change in isometric peak force (knee extension)
Time Frame: 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 |
Baseline and 12 weeks
|
Change in isometric peak force (hip flexion)
Time Frame: 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 |
Baseline and 12 weeks
|
Change in isometric peak force (hip extension)
Time Frame: 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 |
Baseline and 12 weeks
|
Change in hand grip strength
Time Frame: Baseline and 12 weeks
|
Method: Baseline LITE hydraulic dynamometer Analysis: Best of 3 trials
|
Baseline and 12 weeks
|
Change in Burn Specific Health Scale-Brief (BSHS-B)
Time Frame: 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) |
Baseline and 12 weeks
|
Change in EQ-5D-5L
Time Frame: 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
|
Baseline and 12 weeks
|
Number of adverse events
Time Frame: Baseline and 12 weeks
|
Recording of complications during exercise: Graft take, Wound infections, Medical, Cardio-respiratory safety
|
Baseline and 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ulrike Van Daele, Faculty of Medicine and Health Sciences, University of Antwerp
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11B8619N
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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