A Phase 2 interventional study of Exercise and Standard of Care in Burns, sponsored by Universiteit Antwerpen. Status unknown at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-14.
Sponsored by Universiteit Antwerpen · Phase 2, Interventional, and Treatment
BACKGROUND:
Postburn changes in whole-body, 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 quasi-experimental 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:
Moderate to severely burned adults (10-80%TBSA) will be recruited from two Belgian burn centres.
Subjects allocated to the intervention group will undergo an up to 8-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 effect on muscle wasting will be determined by B-mode ultrasound-derived measures of quadriceps muscle layer thickness (QMLT) and rectus femoris cross sectional area, as well as peak force measurements by handheld dynamometry. Insulin resistance will be derived from the HOMA-2 index based on fasting plasma glucose and insulin. Quality of life will be determined by the EQ-5D-5L and Burn Specific Health Scale-Brief (BSHS-B) questionnaires.
The results of this clinical research will provide insight into the effects of exercise on both a fundamental and clinical spectrum.
The added exercise intervention is initiated in line with the following readiness criteria, which will be 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.
Goal 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. Goal aerobic exercise intensity is set at 50-75% peak Watts determined by a weekly cycle ergometer or treadmill ramp protocol.
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 524 interventional studies indexed under Burns.
Browse Burns studies →Universiteit Antwerpen is the lead sponsor of 128 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard of care treatment: - including passive / assisted / active movements, stretching, functional exercise, scar treatment Duration: up to 8 weeks
Other: Standard of Care
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: up to 8 weeks
Other: Exercise · Other: Standard of Care
Resistance and aerobic exercise in addition to standard of care rehabilitation
Standard of care rehabilitation
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
Time frame: Baseline - Hospital discharge (max. 8 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.
Time frame: Baseline - Hospital discharge (max. 8 weeks)
Change in insulin resistance
Method: HOMA-2 calculated by fasting plasma glucose and insulin
Time frame: Baseline - Hospital discharge (max. 8 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
Time frame: Baseline - Hospital discharge (max. 8 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
Time frame: Baseline - Hospital discharge (max. 8 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
Time frame: Baseline - Hospital discharge (max. 8 weeks)
Change in hand grip strength
Method: Baseline LITE hydraulic dynamometer Analysis: Best of 3 trials
Time frame: Baseline - Hospital discharge (max. 8 weeks)
Change in Burn Specific Health Scale-Brief (BSHS-B)
Burn-specific quality of life, measured by the Burn Specific Health Scale-Brief questionnaire (Dutch and French language 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)
Time frame: Baseline - Hospital discharge (max. 8 weeks)
Change in EQ-5D-5L
Overall quality of life, measured by EQ-5D-5L (Dutch and French language version) Total score: 25 points (0 worst score, 25 best score), consisting of 5 subdomains Mobility (5 points) Self-care (5 points) Usual activities (5 points) pain / discomfort (5 points) Anxiety / Depression (5 points) EQ overall health assessed on a Visual Analogue Scale, Total 0-100 (0 worst, 100 best score)
Time frame: Baseline - Hospital discharge (max. 8 weeks)
Number of adverse events
Recording of complications during exercise: Graft take, Wound infections, Medical, Cardio-respiratory safety
Time frame: Baseline - Hospital discharge (max. 8 weeks)
Plan to share: No — Datasets will be made available upon request.
No publications or documents are linked to this record.
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Universiteit Antwerpen