Effects of Early Exercise Rehabilitation in Severe Burns
Last updated on July 2021Recruitment
- 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