Effects of Exercise During the Acute Phase of Burns
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Burns
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention 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.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 (PaO...
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.
Tracking Information
- NCT #
- NCT04511104
- Collaborators
- Research Foundation Flanders
- Investigators
- Principal Investigator: Ulrike Van Daele University of Antwerp, Faculty of Medicine and Health Sciences
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