BurnsPhase 2NCT04511104
Effects of Exercise During the Acute Phase of Burns
A Phase 2 study testing Exercise in people with Burns, run by Universiteit Antwerpen at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesBelgium
- Study dates
- 4 May 2020to 1 Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥10 - ≤80 %TBSA
- Burn depth: 2nd deep / 3rd degree
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Ulrike Van Daele contact
Belgium2 sites, 2 recruiting
- Recruiting
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, 2060
Cynthia Lafaire, Dr.
Lieve De Cuyper, Dr.
- Recruiting
Militaire Hospitaal Koningin Astrid, Neder-Over-Heembeek
Brussels, 1120
Thomas Rose, Dr.
About this study
Official title: Effects of Exercise During the Acute Phase of Burns: A Multicenter Trial in Belgium
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.
Read more
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.
Read the 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.
- Conditions
- Burns
- Being tested
- Exercise, Standard of Care
- Keywords
- Burns, Exercise rehabilitation, Exercise Therapy, Muscle wasting, Hypermetabolism, Insulin resistance
- Medical subject headings
- Burns, Muscular Atrophy, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Resistance and aerobic exercise in addition to standard of care rehabilitation
Standard of CareOther
Standard of care rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Standard of care treatment:
- including passive / assisted / active movements, stretching, functional exercise, scar treatment
Duration: up to 8 weeks Receives: Other: Standard of Care |
| Exercise | Experimental | 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: up to 8 weeks Receives: Other: Exercise; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline - Hospital discharge (max. 8 weeks)
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.
Measured: Baseline - Hospital discharge (max. 8 weeks)
Secondary outcomes (1)
Change in insulin resistance
Method: HOMA-2 calculated by fasting plasma glucose and insulin
Measured: Baseline - Hospital discharge (max. 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start4 May 2020
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Principal investigator, Ulrike Van Daele, Universiteit Antwerpen
- Investigators
- Ulrike Van Daele, Principal investigator, University of Antwerp, Faculty of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511104
- Sponsor's protocol ID
- 11B8619N[BEL]
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Datasets will be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise During the Acute Phase of Burns: A Multicenter Trial in Belgium
- ClinicalTrials.gov ID
- NCT04511104
- Acronym / sponsor ID
- 11B8619N[BEL]
- Conditions
- Burns
- Keywords
- Burns, Exercise rehabilitation, Exercise Therapy, Muscle wasting, Hypermetabolism, Insulin resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 4 May 2020 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CareStandard of care treatment: - including passive / assisted / active movements, stretching, functional exercise, scar treatment Duration: up to 8 weeks |
| Exercise | Experimental | Other: Exercise, Other: Standard of CareStandard 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: up to 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥10 - ≤80 %TBSA
- Burn depth: 2nd deep / 3rd degree
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseResistance and aerobic exercise in addition to standard of care rehabilitation | Other | Exercise |
| Standard of CareStandard of care rehabilitation | Other | Exercise, Standard of Care |
Primary outcome
Change in quadriceps muscle layer thickness (QMLT)
Time frame: Baseline - Hospital discharge (max. 8 weeks)
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)
Time frame: Baseline - Hospital discharge (max. 8 weeks)
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.
1 secondary outcome
Change in insulin resistance
Time frame: Baseline - Hospital discharge (max. 8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Individual participant dataSharing planned: No. Datasets will be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrike Van Daele contact
Ulrike Van Daele principal investigator
University of Antwerp, Faculty of Medicine and Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise in people with Burns, run by Universiteit Antwerpen at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David R Schieffelers (+3232659177, david.schieffelers@uantwerp.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quadriceps muscle layer thickness (QMLT) (time frame: Baseline - Hospital discharge (max. 8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.