Clinical trial NCT04511104: Effects of Exercise During the Acute Phase of Burns
Official title: Effects of Exercise During the Acute Phase of Burns: A Multicenter Trial in Belgium
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
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
First posted: 2020-08-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Trial phase 1: All eligible subjects will be allocated to the intervention group until n=20 has been reached. To reduce staff workload during phase 1, patients will be allocated to the control group if staff capacity (max. 2 patients per full time employed physiotherapist) is saturated.

Trial phase 2: When n=20 has been reached in the intervention group, all further eligible patients will be allocated to the control group for the remaining recruitment period.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in quadriceps muscle layer thickness (QMLT)
timeFrame: Baseline - Hospital discharge (max. 8 weeks)
measure: Change in rectus femoris cross sectional area (RF-CSA)
timeFrame: Baseline - Hospital discharge (max. 8 weeks)
Secondary outcomes:
measure: Change in insulin resistance
timeFrame: Baseline - Hospital discharge (max. 8 weeks)
Other outcomes:
measure: Change in isometric peak force (knee extension)
timeFrame: Baseline - Hospital discharge (max. 8 weeks)
measure: Change in isometric peak force (hip flexion)
timeFrame: Baseline - Hospital discharge (max. 8 weeks)
measure: Change in isometric peak force (hip extension)
timeFrame: Baseline - Hospital discharge (max. 8 weeks)
measure: Change in hand grip strength
timeFrame: Baseline - Hospital discharge (max. 8 weeks)
measure: Change in Burn Specific Health Scale-Brief (BSHS-B)
timeFrame: Baseline - Hospital discharge (max. 8 weeks)
measure: Change in EQ-5D-5L
timeFrame: Baseline - Hospital discharge (max. 8 weeks)
measure: Number of adverse events
timeFrame: Baseline - Hospital discharge (max. 8 weeks)
Locations:
city: Antwerp
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen Stuivenberg
city: Brussels
country: Belgium
facility: Militaire Hospitaal Koningin Astrid, Neder-Over-Heembeek
Study officials:
affiliation: University of Antwerp, Faculty of Medicine and Health Sciences
name: Ulrike Van Daele
role: PRINCIPAL_INVESTIGATOR
References: