Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-24 @ 4:27 AM
Study NCT ID:
NCT04372550
Status:
UNKNOWN
Last Update Posted:
2020-08-12
First Post:
2020-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Early Exercise Rehabilitation in Severe Burns
Sponsor:
Universiteit Antwerpen
Organization:
Study Overview
Official Title:
Pathophysiological Mechanisms and Early Exercise Rehabilitation Counter Measures of Hypermetabolism and Muscle Wasting in Severe Burns.
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: