Effects of Early Exercise Rehabilitation in Severe Burns

NCT04372550 | Unknown

• 1 other identifier: 11B8619N
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

Burns; Exercise rehabilitation; Exercise Therapy; Muscle wasting; Hypermetabolism; Insulin resistance

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Change in insulin resistance

  Baseline and 12 weeks

Other Outcomes (14)

• Change in Interleukin-1

  Baseline and 12 weeks

• Change in Interleukin-6

  Baseline and 12 weeks

• Change in Tumor Necrosis Factor alpha (TNF-α)

  Baseline and 12 weeks

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Standard of care treatment: \- including passive / assisted / active movements, stretching, functional exercise, scar treatment Duration: 6-12 weeks

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: 6-12 weeks

Other: Exercise; Other: Standard of Care

Interventions

Exercise OTHER

Resistance and aerobic exercise in addition to standard of care rehabilitation

Exercise

Standard of Care OTHER

Standard of care rehabilitation

Exercise; Standard of Care

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≥40 - ≤70 %TBSA
• Burn depth: 2nd deep / 3rd degree

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• Research Foundation Flanders: collaborator
• Wuhan Third Hospital: collaborator

Study Sites (1)

Institute of Burns, Wuhan Third Hospital & Tongren Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

MeSH Terms

Conditions

Burns; Muscular Atrophy; Insulin Resistance

Interventions

Exercise; Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ulrike Van Daele

  Faculty of Medicine and Health Sciences, University of Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David R Schieffelers

CONTACT

+32465419848; david.schieffelers@uantwerp.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Analysis of the primary outcome is carried out blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 4, 2020
• Study Start: November 25, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)