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Clinical Trials/NCT05988294
NCT05988294CompletedNot Applicable

Pulmonary Function, Respiratory Muscle Strength and Functional Capacity Response to Pilates Exercises in Patients with Inhalation Injury After Thermal Burn.

Cairo University1 site in 1 country60 target enrollmentStarted: July 30, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Forced vital capacity (FVC)

Study Overview

Brief Summary

Inhalation injury is a composite of multiple insults including: supraglottic thermal injury, subglottic airway and alveolar poisoning, and systemic poisoning from absorbed small molecule toxins. These contaminant insults independently affect each of the pulmonary functions as well as having a direct effect on systemic physiology. Further, anatomic characteristics can predispose patients to inhalation injury. For example, an infant will develop airway obstructions much faster than an adult due to reduced airway diameter. Understanding the contributions of each of these pathologies to the patient's disease is critical to managing inhalation injury.

Detailed Description

Extra lung mucus secretions, injured mucosa, contaminants, and aspirated substances should be handled in their early stages. In the case of fibrinous material transudates, compromised mucociliary secretions and mucosal slough must be cleared. There are different methods to assist the clearance of secretions as bronchoscopy, ventilator, mucolytics, suction, and chest physiotherapy.

In Pilates method (PM), several muscles are activated, including the muscles involved in breathing, especially to improve the expiratory function, which remains contracted during the inspiratory and expiratory phase. Breathing control is fundamental during the execution of PM exercises, where the practitioner learns how to breathe properly as an essential part of each exercise through forceful exhaling followed by complete inhaling. Thus, adequate breathing aids in controlling movements, and therefore, the method can be regarded as an indirect strategy for respiratory muscle training. It is known that poor control of breathing can result in compensation and lung volumes and respiratory muscle performance, with several factors involved.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Care Provider)

Eligibility Criteria

Ages
20 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients in both sexes and their age will range from 20-50 years.
  • •Six weeks after deep second-degree thermal burn with inhalation injury (until complete healing) with 35%-40% total body surface area (TBSA).
  • •Patients suffering from retained secretions which did not respond to medical treatment. (4) All patients should be clinically and medically stable.
  • •(5) All patients should have the same medical treatment.

Exclusion Criteria

  • •Participants with a history of regular physical activity (regular exercise habit > 3 times/ week or >150 min/ week) in the last 6 months.
  • •Participants with less than an 85% attendance rate at the sessions.
  • •Participants with any dysfunction that limit physical activity such as neurological disorders, chronic obstructive pulmonary disease, uncontrolled hypertension, malignancy, cardiovascular diseases, deep vein thrombosis, rheumatoid arthritis, orthopedic problems, such as fracture on the pelvic or limbs, a visual impairment, or hearing impairments and contractures.
  • •Pregnant females.
  • •Obese participants (BMI > 30 kg/m2).
  • •Participants use non-invasive mechanical ventilation and intubation or need for intensive clinical support and/or transfer to the Intensive Care Unit.

Arms & Interventions

Group A (Pilates Group)

Experimental

Participants will receive Pilates exercises for 60 minutes followed by conventional physical therapy program for 45 minutes, 3 days/ week for 12 weeks.

Intervention: Pilates exercises (Other)

Group A (Pilates Group)

Experimental

Participants will receive Pilates exercises for 60 minutes followed by conventional physical therapy program for 45 minutes, 3 days/ week for 12 weeks.

Intervention: Conventional physical therapy exercise program (Other)

Group B (Control Group)

Other

Participants will receive conventional physical therapy program (diaphragmatic deep breathing exercises, bronchial hygiene techniques, assisted cough, stretching exercises and ROM exercises for both upper and lower limbs) for 45 minutes, 3 days/ week for 12 weeks.

Intervention: Conventional physical therapy exercise program (Other)

Outcomes

Primary Outcomes

Forced vital capacity (FVC)

Time Frame: 12 weeks

Forced vital capacity (FVC) will be measured by using spirometer

forced expiratory volume in 1 second (FEV1)

Time Frame: 12 weeks

forced expiratory volume in 1 second (FEV1) will be measured by using spirometer

peak expiratory flow (PEF)

Time Frame: 12 weeks

peak expiratory flow (PEF) will be measured by using spirometer

Secondary Outcomes

  • Respiratory muscle strength(12 weeks)
  • Functional capacity(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nesma Morgan Allam

Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Cairo University

Study Sites (1)

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