Clinical trial NCT05988294: Pilates Exercises in Patients with Inhalation Injury
Official title: Pulmonary Function, Respiratory Muscle Strength and Functional Capacity Response to Pilates Exercises in Patients with Inhalation Injury After Thermal Burn.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inhalation Injury
Keywords: Pilates exercises
Pulmonary Function
Respiratory Muscle Strength
Functional Capacity Response
Inhalation Injury
Thermal Burn
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Forced vital capacity (FVC)
timeFrame: 12 weeks
measure: forced expiratory volume in 1 second (FEV1)
timeFrame: 12 weeks
measure: peak expiratory flow (PEF)
timeFrame: 12 weeks
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: 12 weeks
measure: Functional capacity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Lecturer of basic science, Faculty of Physical Therapy Cairo University
name: Doaa A Elimy, PhD
role: STUDY_DIRECTOR
References: