Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT04511104
Status:
UNKNOWN
Last Update Posted:
2020-08-14
First Post:
2020-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Exercise During the Acute Phase of Burns
Sponsor:
Universiteit Antwerpen
Organization:
Study Overview
Official Title:
Effects of Exercise During the Acute Phase of Burns: A Multicenter Trial in Belgium
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 whole-body, 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 quasi-experimental 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:
Moderate to severely burned adults (10-80%TBSA) will be recruited from two Belgian burn centres.
Subjects allocated to the intervention group will undergo an up to 8-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 effect on muscle wasting will be determined by B-mode ultrasound-derived measures of quadriceps muscle layer thickness (QMLT) and rectus femoris cross sectional area, as well as peak force measurements by handheld dynamometry. Insulin resistance will be derived from the HOMA-2 index based on fasting plasma glucose and insulin. Quality of life will be determined by the EQ-5D-5L and Burn Specific Health Scale-Brief (BSHS-B) questionnaires.
The results of this clinical research will provide insight into the effects of exercise on both a fundamental and clinical spectrum.
Postburn changes in whole-body, 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 quasi-experimental 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:
Moderate to severely burned adults (10-80%TBSA) will be recruited from two Belgian burn centres.
Subjects allocated to the intervention group will undergo an up to 8-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 effect on muscle wasting will be determined by B-mode ultrasound-derived measures of quadriceps muscle layer thickness (QMLT) and rectus femoris cross sectional area, as well as peak force measurements by handheld dynamometry. Insulin resistance will be derived from the HOMA-2 index based on fasting plasma glucose and insulin. Quality of life will be determined by the EQ-5D-5L and Burn Specific Health Scale-Brief (BSHS-B) questionnaires.
The results of this clinical research will provide insight into the effects 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 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.
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.
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?: