Effects of Early Exercise Rehabilitation in Severe Burns

U

Universiteit Antwerpen

Status

Unknown

Conditions

Burns

Treatments

Other: Exercise
Other: Standard of Care

Study type

Interventional

Funder types

Other

Identifiers

NCT04372550
11B8619N

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Standard of Care
Active Comparator group
Description:
Standard of care treatment: - including passive / assisted / active movements, stretching, functional exercise, scar treatment Duration: 6-12 weeks
Treatment:
Other: Standard of Care
Exercise
Experimental group
Description:
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
Treatment:
Other: Standard of Care
Other: Exercise

Trial contacts and locations

0

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Central trial contact

David R Schieffelers

Data sourced from clinicaltrials.gov

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