Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Burns
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized Controlled TrialMasking: None (Open Label)Masking Description: Analysis of the primary outcome is carried out blind.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 64 years
Gender
Both males and females

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 / fracti...

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.

Tracking Information

NCT #
NCT04372550
Collaborators
  • Research Foundation Flanders
  • Wuhan Third Hospital
Investigators
Principal Investigator: Ulrike Van Daele Faculty of Medicine and Health Sciences, University of Antwerp