Effects of Exercise During the Acute Phase of Burns

NCT04511104 | Unknown Phase 2

• 1 other identifier: 11B8619N[BEL]
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

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 - 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.

  Baseline - Hospital discharge (max. 8 weeks)

Secondary Outcomes (1)

• Change in insulin resistance

  Baseline - Hospital discharge (max. 8 weeks)

Other Outcomes (7)

• Change in isometric peak force (knee extension)

  Baseline - Hospital discharge (max. 8 weeks)

• Change in isometric peak force (hip flexion)

  Baseline - Hospital discharge (max. 8 weeks)

• Change in isometric peak force (hip extension)

  Baseline - Hospital discharge (max. 8 weeks)

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Standard of care treatment: \- including passive / assisted / active movements, stretching, functional exercise, scar treatment Duration: up to 8 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: up to 8 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+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥10 - ≤80 %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

Study Sites (2)

Ziekenhuis Netwerk Antwerpen Stuivenberg

Antwerp, 2060, Belgium

RECRUITING

Militaire Hospitaal Koningin Astrid, Neder-Over-Heembeek

Brussels, 1120, Belgium

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

  University of Antwerp, Faculty of Medicine and Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David R Schieffelers

CONTACT

+3232659177; david.schieffelers@uantwerp.be

Ulrike Van Daele

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University professor

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: May 4, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: August 14, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)