Effects of Exercise During the Acute Phase of Burns

NCT ID: NCT04511104

Last Updated: 2020-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-04
• Study Completion Date: 2022-04-01

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

Standard of care treatment:

• including passive / assisted / active movements, stretching, functional exercise, scar treatment

Duration: up to 8 weeks

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Standard of care rehabilitation

Exercise

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

Resistance and aerobic exercise in addition to standard of care rehabilitation

Standard of Care

Intervention Type: OTHER

Standard of care rehabilitation

Interventions

Exercise

Resistance and aerobic exercise in addition to standard of care rehabilitation

Intervention Type: OTHER

Standard of Care

Standard of care rehabilitation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ≥10 - ≤80 %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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Foundation Flanders

OTHER

Sponsor Role: collaborator

Universiteit Antwerpen

OTHER

Sponsor Role: lead

Responsible Party

Ulrike Van Daele

University professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulrike Van Daele

Role: PRINCIPAL_INVESTIGATOR

University of Antwerp, Faculty of Medicine and Health Sciences

Locations

Ziekenhuis Netwerk Antwerpen Stuivenberg

Antwerp, , Belgium

Site Status: RECRUITING

Militaire Hospitaal Koningin Astrid, Neder-Over-Heembeek

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

David R Schieffelers

Role: CONTACT

david.schieffelers@uantwerp.be

+3232659177

Ulrike Van Daele

Role: CONTACT

Facility Contacts

Cynthia Lafaire, Dr.

Role: primary

Lieve De Cuyper, Dr.

Role: backup

Thomas Rose, Dr.

Role: primary

Other Identifiers

11B8619N[BEL]

Identifier Type: -

Identifier Source: org_study_id