Clinical trial NCT04372550: Effects of Early Exercise Rehabilitation in Severe Burns
Official title: Pathophysiological Mechanisms and Early Exercise Rehabilitation Counter Measures of Hypermetabolism and Muscle Wasting in Severe Burns.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burns
Keywords: Burns
Exercise rehabilitation
Exercise Therapy
Muscle wasting
Hypermetabolism
Insulin resistance
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
name: Wuhan Third Hospital
First posted: 2020-05-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in quadriceps muscle layer thickness (QMLT)
timeFrame: Baseline - 12 weeks
measure: Change in rectus femoris cross sectional area (RF-CSA)
timeFrame: Baseline - 12 weeks
Secondary outcomes:
measure: Change in insulin resistance
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Change in Interleukin-1
timeFrame: Baseline and 12 weeks
measure: Change in Interleukin-6
timeFrame: Baseline and 12 weeks
measure: Change in Tumor Necrosis Factor alpha (TNF-α)
timeFrame: Baseline and 12 weeks
measure: Change in C-reactive protein
timeFrame: Baseline and 12 weeks
measure: Change in Insulin like growth factor 1 (IGF-1)
timeFrame: Baseline and 12 weeks
measure: Change in Glucagon
timeFrame: Baseline and 12 weeks
measure: Change in Myostatin
timeFrame: Baseline and 12 weeks
measure: Change in isometric peak force (knee extension)
timeFrame: Baseline and 12 weeks
measure: Change in isometric peak force (hip flexion)
timeFrame: Baseline and 12 weeks
measure: Change in isometric peak force (hip extension)
timeFrame: Baseline and 12 weeks
measure: Change in hand grip strength
timeFrame: Baseline and 12 weeks
measure: Change in Burn Specific Health Scale-Brief (BSHS-B)
timeFrame: Baseline and 12 weeks
measure: Change in EQ-5D-5L
timeFrame: Baseline and 12 weeks
measure: Number of adverse events
timeFrame: Baseline and 12 weeks
Locations:
city: Wuhan
country: China
facility: Institute of Burns, Wuhan Third Hospital & Tongren Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Faculty of Medicine and Health Sciences, University of Antwerp
name: Ulrike Van Daele
role: PRINCIPAL_INVESTIGATOR
References: