Effects of Exercise During the Acute Phase of Burns: A Multicenter Trial in Belgium
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Universiteit Antwerpen
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Change in rectus femoris cross sectional area (RF-CSA)
Study Overview
Brief Summary
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.
Detailed Description
The added exercise intervention is initiated in line with the following readiness criteria, which will be checked prior to each training session:
Criteria:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥10 - ≤80 %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
Arms & Interventions
Standard of Care
Standard of care treatment:
- including passive / assisted / active movements, stretching, functional exercise, scar treatment
Duration: up to 8 weeks
Intervention: Standard of Care (Other)
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: up to 8 weeks
Intervention: Exercise (Other)
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: up to 8 weeks
Intervention: Standard of Care (Other)
Outcomes
Primary Outcomes
Change in rectus femoris cross sectional area (RF-CSA)
Time Frame: Baseline - Hospital discharge (max. 8 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.
Change in quadriceps muscle layer thickness (QMLT)
Time Frame: Baseline - Hospital discharge (max. 8 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
Secondary Outcomes
- Change in insulin resistance(Baseline - Hospital discharge (max. 8 weeks))
Investigators
Ulrike Van Daele
University professor
Universiteit Antwerpen