Effects of Early Exercise Rehabilitation in Severe Burns
Primary Purpose
Burns
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Exercise
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring Burns, Exercise rehabilitation, Exercise Therapy, Muscle wasting, Hypermetabolism, Insulin resistance
Eligibility Criteria
Inclusion Criteria:
- ≥40 - ≤70 %TBSA
- Burn depth: 2nd deep / 3rd degree
Exclusion Criteria:
- Electrical burn (except flash burns)
- Associated injury: fracture lower limb
- Diabetes Mellitus type 1
- Central neurological/neuromuscular disorders (interfering with assessment/exercise)
- Cognitive / psychological disorders (interfering with cooperation)
- Cardiopulmonary disease (interfering with exercise safety)
- Pregnancy
- Palliative care
Sites / Locations
- Institute of Burns, Wuhan Third Hospital & Tongren Hospital of Wuhan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care
Exercise
Arm Description
Standard of care treatment: - including passive / assisted / active movements, stretching, functional exercise, scar treatment Duration: 6-12 weeks
Standard of care + added exercises Exercise type: resistance and aerobic exercise Resistance Exercise: 3x / week (manual resistance, free weights, machines) Aerobic exercise: 2x / week (cycle ergometer, treadmill) Duration: 6-12 weeks
Outcomes
Primary Outcome Measures
Change in quadriceps muscle layer thickness (QMLT)
Method: B-mode ultrasound on the anterior aspect of the thigh. Technique: maximal and minimal pressure Location: measured at 1/2 and 2/3 of the distance between anterior superior iliac spine and the superior pole of the patella.
Analysis: An average of 3 trials will be recorded and analyzed using dedicated software
Change in rectus femoris cross sectional area (RF-CSA)
Method: B-mode ultrasound on the anterior aspect of the thigh. Technique: minimal pressure. Location: measured at the most proximal distance where the entire muscle belly is still visible on the ultrasound image.
Analysis: An average of 3 trials will be recorded and analyzed using dedicated software.
Secondary Outcome Measures
Change in insulin resistance
Method: HOMA-2 calculated by fasting plasma glucose and insulin, analysed by Western Blot Chemiluminescence
Full Information
NCT ID
NCT04372550
First Posted
April 30, 2020
Last Updated
August 10, 2020
Sponsor
Universiteit Antwerpen
Collaborators
Research Foundation Flanders, Wuhan Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04372550
Brief Title
Effects of Early Exercise Rehabilitation in Severe Burns
Official Title
Pathophysiological Mechanisms and Early Exercise Rehabilitation Counter Measures of Hypermetabolism and Muscle Wasting in Severe Burns.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen
Collaborators
Research Foundation Flanders, Wuhan Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Burns, Exercise rehabilitation, Exercise Therapy, Muscle wasting, Hypermetabolism, Insulin resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Masking Description
Analysis of the primary outcome is carried out blind.
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard of care treatment:
- including passive / assisted / active movements, stretching, functional exercise, scar treatment
Duration: 6-12 weeks
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Standard of care + added exercises
Exercise type: resistance and aerobic exercise
Resistance Exercise: 3x / week (manual resistance, free weights, machines) Aerobic exercise: 2x / week (cycle ergometer, treadmill)
Duration: 6-12 weeks
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Resistance and aerobic exercise in addition to standard of care rehabilitation
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of care rehabilitation
Primary Outcome Measure Information:
Title
Change in quadriceps muscle layer thickness (QMLT)
Description
Method: B-mode ultrasound on the anterior aspect of the thigh. Technique: maximal and minimal pressure Location: measured at 1/2 and 2/3 of the distance between anterior superior iliac spine and the superior pole of the patella.
Analysis: An average of 3 trials will be recorded and analyzed using dedicated software
Time Frame
Baseline - 12 weeks
Title
Change in rectus femoris cross sectional area (RF-CSA)
Description
Method: B-mode ultrasound on the anterior aspect of the thigh. Technique: minimal pressure. Location: measured at the most proximal distance where the entire muscle belly is still visible on the ultrasound image.
Analysis: An average of 3 trials will be recorded and analyzed using dedicated software.
Time Frame
Baseline - 12 weeks
Secondary Outcome Measure Information:
Title
Change in insulin resistance
Description
Method: HOMA-2 calculated by fasting plasma glucose and insulin, analysed by Western Blot Chemiluminescence
Time Frame
Baseline and 12 weeks
Other Pre-specified Outcome Measures:
Title
Change in Interleukin-1
Description
Western Blot Chemiluminescence
Time Frame
Baseline and 12 weeks
Title
Change in Interleukin-6
Description
Western Blot Chemiluminescence
Time Frame
Baseline and 12 weeks
Title
Change in Tumor Necrosis Factor alpha (TNF-α)
Description
Western Blot Chemiluminescence
Time Frame
Baseline and 12 weeks
Title
Change in C-reactive protein
Description
Western Blot Chemiluminescence
Time Frame
Baseline and 12 weeks
Title
Change in Insulin like growth factor 1 (IGF-1)
Description
Western Blot Chemiluminescence
Time Frame
Baseline and 12 weeks
Title
Change in Glucagon
Description
ELISA kits DGCG0, R&D Systems, Inc, USA
Time Frame
Baseline and 12 weeks
Title
Change in Myostatin
Description
ELISA kits DGDF80, R&D Systems, Inc, USA
Time Frame
Baseline and 12 weeks
Title
Change in isometric peak force (knee extension)
Description
Method: Hand-held dynamometry (Lafayette instrument Co. Europe, U.K.). Isometric peak fore is measured by a 'make' manoeuvre with a fixation band disallowing movement.
Test position: Supine with a fixation band fixed to the hospital bed. Analysis: Best of 3 trials
Time Frame
Baseline and 12 weeks
Title
Change in isometric peak force (hip flexion)
Description
Method: Hand-held dynamometry (Lafayette instrument Co. Europe, U.K.). Isometric peak fore is measured by a 'make' manoeuvre with a fixation band disallowing movement.
Test position: Supine with a fixation band fixed to the hospital bed. Analysis: Best of 3 trials
Time Frame
Baseline and 12 weeks
Title
Change in isometric peak force (hip extension)
Description
Method: Hand-held dynamometry (Lafayette instrument Co. Europe, U.K.). Isometric peak fore is measured by a 'make' manoeuvre with a fixation band disallowing movement.
Test position: Supine with a fixation band fixed to the hospital bed. Analysis: Best of 3 trials
Time Frame
Baseline and 12 weeks
Title
Change in hand grip strength
Description
Method: Baseline LITE hydraulic dynamometer Analysis: Best of 3 trials
Time Frame
Baseline and 12 weeks
Title
Change in Burn Specific Health Scale-Brief (BSHS-B)
Description
Burn-specific quality of life, measured by the Burn Specific Health Scale-Brief questionnaire (Mandarin Chinese version).
Total score 152 (0 worst score, 152 best score), consisting of 6 subdomains:
1) Body imagine (36 points) Simple abilities (36 points) Sexuality (24 points) Affect (32 points) Work (16 points) Interpersonal relationship (8 points)
Time Frame
Baseline and 12 weeks
Title
Change in EQ-5D-5L
Description
Overall quality of life, measured by EQ-5D-5L (Mandarin Chinese version) Total score: 25 points (0 worst score, 25 best score), consisting of 5 subdomains
Mobility (5 points)
Self-care (5 points)
Usual activities (5 points)
pain / discomfort (5 points)
Anxiety / Depression (5 points) EQ overall health assessed on a Visual Analogue Scale, Total 0-100 (0 worst, 100 best score)
Time Frame
Baseline and 12 weeks
Title
Number of adverse events
Description
Recording of complications during exercise: Graft take, Wound infections, Medical, Cardio-respiratory safety
Time Frame
Baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥40 - ≤70 %TBSA
Burn depth: 2nd deep / 3rd degree
Exclusion Criteria:
Electrical burn (except flash burns)
Associated injury: fracture lower limb
Diabetes Mellitus type 1
Central neurological/neuromuscular disorders (interfering with assessment/exercise)
Cognitive / psychological disorders (interfering with cooperation)
Cardiopulmonary disease (interfering with exercise safety)
Pregnancy
Palliative care
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David R Schieffelers
Phone
+32465419848
Email
david.schieffelers@uantwerp.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Van Daele
Organizational Affiliation
Faculty of Medicine and Health Sciences, University of Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Burns, Wuhan Third Hospital & Tongren Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xie Weiguo
Phone
+8618071085225
Email
wgxie@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Datasets will be made available upon request.
Learn more about this trial
Effects of Early Exercise Rehabilitation in Severe Burns
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