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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05886543
Other study ID # 341989
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 30, 2021
Est. completion date January 30, 2023

Study information

Verified date May 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Sixty patients with 25-45 years of age presenting post burn inhalation injury, randomly distributed into two equal groups, 30 patients for each group. control group receive conventional chest physiotherapy (diaphragmatic respiratory exercises, apical breathing exercises) for (15-20) minutes 3times/week and medical treatment for 4 weeks as a total period of treatment. study group will receive pilates exercise in addition to their conventional chest physiotherapy for (15-20) minutes 3times/week and medical treatment for 4 weeks as a total period of treatment, computerized spirometer assessment before treatment are ( The following variables were measured: forced vital capacity (PVC%) and forced ·expiratory volume in one second (FEVl %) and peak expiratory flow (PEF %)and after one month


Description:

Two groups of sixty patients (thirty patients in each group) of both sexes of inhalation injury post burn are selected randomly to participate in the study. The patients will be divided into two equal groups in number: - Group (A) study group: this group includes 30 patients who have postburn inhalation injury will receive conventional chest physiotherapy (diaphragmatic respiratory exercises, deep inhalation exercises, and respiratory exercises associated with shoulder flexion movements and extension of the upper limbs, assisted cough, circulatory exercises and early ambulation) and medical treatment and pilates method. - Group (B) control group: this group includes 30 patients who have postburn inhalation injury will receive conventional chest physiotherapy (diaphragmatic respiratory exercises, deep inhalation exercises, and respiratory exercises associated with shoulder flexion movements and extension of the upper limbs, assisted cough, circulatory exercises and early ambulation) and medical treatment. - computerized spirometer assessment before treatment are ( The following variables were measured: forced vital capacity (PVC%) and forced ·expiratory volume in one second (FEVl %) and peak expiratory flow (PEF %)and after one month


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 30, 2023
Est. primary completion date November 20, 2021
Accepts healthy volunteers No
Gender All
Age group 25 Years to 45 Years
Eligibility Inclusion Criteria: - Age ranged between 25-45 years. - All patients presented post-burn inhalation injury. - Patients with facial burn or upper limb burn. - All patients would be free of acute or chronic pulmonary disease and will have the capacity to perform the protocol evaluation tests properly. - All patients enrolled to the study would have their informed consent. Exclusion Criteria: - Cardiac diseases. - Chronic pulmonary disorders. - Previous or present smoking history. - Female patients who are pregnant and lactating. - Post-burn patient on ICU.

Study Design


Intervention

Behavioral:
Conventional chest physical therapy
Conventional chest physical therapy: The patients performed four series of five breath with 3 seconds of sustained breathing interspersed with periods of quite breathing followed by two or three coughs or huffs (with wound support by a pillow or his/her hands), twice a day in the first two postburned days and once a day from the third to the tenth days.
Pilates exercise
The Pilates technique, which stretched laterally and to the back, stressed costal breathing, in which the ribs climb and drop throughout the ventilatory stream. The transverse muscle had to work harder to avoid abdominal distension, provide more support to the diaphragm to promote lower rib movement, and provide more diaphragmatic excursion, During the expiratory phase, the transversus abdominis, the multifidus and the pelvic floor musculature were contracted.

Locations

Country Name City State
Egypt faculty of physical therapy , Cairo university Giza

Sponsors (2)

Lead Sponsor Collaborator
Khadra Mohamed Ali Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of Pulmonary Function (spirometry) Spirometric evaluation had been undertaken on pre-rehabilitation. The following variables were measured: forced vital capacity (PVC%) and forced ·expiratory volume in one second (FEVl %) and peak expiratory flow (PEF %), by spirometry (ZAN 100 Handy 11- TB 100 E006) with the subject upright sitting or lying in the supine posture one month
Secondary Measurement of anthropometric parameters. Before spirometry testing, height and weight should be determined to find the body mass index essential in spirometry test. Standing height was measured in centimeters with· a measuring scale. Weight was measured in kilograms on a standardized weighing machine before spirometer test
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