Inhalation Injury Clinical Trial
Official title:
Pulmonary Function, Respiratory Muscle Strength and Functional Capacity Response to Pilates Exercises in Patients With Inhalation Injury After Thermal Burn.
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | May 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 50 Years |
Eligibility | Inclusion Criteria: 1. Patients in both sexes and their age will range from 20-50 years. 2. Six weeks after deep second-degree thermal burn with inhalation injury (until complete healing) with 35%-40% total body surface area (TBSA). 3. 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: 1. Participants with a history of regular physical activity (regular exercise habit > 3 times/ week or >150 min/ week) in the last 6 months. 2. Participants with less than an 85% attendance rate at the sessions. 3. 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. 4. Smokers. 5. Pregnant females. 6. Obese participants (BMI > 30 kg/m2). 7. Participants use non-invasive mechanical ventilation and intubation or need for intensive clinical support and/or transfer to the Intensive Care Unit. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Physical Therapy | Giza |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Forced vital capacity (FVC) | Forced vital capacity (FVC) will be measured by using spirometer | 12 weeks | |
Primary | forced expiratory volume in 1 second (FEV1) | forced expiratory volume in 1 second (FEV1) will be measured by using spirometer | 12 weeks | |
Primary | peak expiratory flow (PEF) | peak expiratory flow (PEF) will be measured by using spirometer | 12 weeks | |
Secondary | Respiratory muscle strength | The inspiratory muscle strength will be verified by means of the maximum inspiratory pressure (MIP) and the expiratory muscular strength by means of maximum expiratory pressure (MEP) by using the digital Manovacuometer | 12 weeks | |
Secondary | Functional capacity | By using 6-Minute Walk Test (6-MWT) that measures the maximum distance walked in a period of 6 min to assess the submaximal level of the functional capacity of the participants | 12 weeks |
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