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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04372550
Other study ID # 11B8619N
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 25, 2019
Est. completion date October 2021

Study information

Verified date August 2020
Source Universiteit Antwerpen
Contact David R Schieffelers
Phone +32465419848
Email david.schieffelers@uantwerp.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date October 2021
Est. primary completion date October 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise
Resistance and aerobic exercise in addition to standard of care rehabilitation
Standard of Care
Standard of care rehabilitation

Locations

Country Name City State
China Institute of Burns, Wuhan Third Hospital & Tongren Hospital of Wuhan University Wuhan Hubei

Sponsors (3)

Lead Sponsor Collaborator
Universiteit Antwerpen Institute of Burns, Wuhan Third Hospital, Tongren Hospital Wuhan University, Research Foundation Flanders

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Interleukin-1 Western Blot Chemiluminescence Baseline and 12 weeks
Other Change in Interleukin-6 Western Blot Chemiluminescence Baseline and 12 weeks
Other Change in Tumor Necrosis Factor alpha (TNF-a) Western Blot Chemiluminescence Baseline and 12 weeks
Other Change in C-reactive protein Western Blot Chemiluminescence Baseline and 12 weeks
Other Change in Insulin like growth factor 1 (IGF-1) Western Blot Chemiluminescence Baseline and 12 weeks
Other Change in Glucagon ELISA kits DGCG0, R&D Systems, Inc, USA Baseline and 12 weeks
Other Change in Myostatin ELISA kits DGDF80, R&D Systems, Inc, USA Baseline and 12 weeks
Other Change in isometric peak force (knee extension) 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
Baseline and 12 weeks
Other Change in isometric peak force (hip flexion) 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
Baseline and 12 weeks
Other Change in isometric peak force (hip extension) 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
Baseline and 12 weeks
Other Change in hand grip strength Method: Baseline LITE hydraulic dynamometer Analysis: Best of 3 trials Baseline and 12 weeks
Other Change in Burn Specific Health Scale-Brief (BSHS-B) 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)
Baseline and 12 weeks
Other Change in EQ-5D-5L 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)
Baseline and 12 weeks
Other Number of adverse events Recording of complications during exercise: Graft take, Wound infections, Medical, Cardio-respiratory safety Baseline and 12 weeks
Primary 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
Baseline - 12 weeks
Primary 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.
Baseline - 12 weeks
Secondary Change in insulin resistance Method: HOMA-2 calculated by fasting plasma glucose and insulin, analysed by Western Blot Chemiluminescence Baseline and 12 weeks
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