Pilates Exercise and Inhalation Injury Post Burn (burn)

Pilates Exercise and Lung Functions in Postburn Inhalation Injury Patients.

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

Study Overview

• Status: Completed
• Conditions: Inhalation Injury
• Intervention / Treatment: Behavioral: Conventional chest physical therapy; Behavioral: Pilates exercise

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • faculty of physical therapy , Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: control group; this group includes 30 patients who have post burn inhalation injury will receive 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	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.; Behavioral: 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.
Experimental: study group; this group includes 30 patients who have post burn inhalation injury 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.omputerized 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	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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Khadra Mohamed Ali
• Collaborators: Cairo University
• Investigators: Principal Investigator: Ali, a, assist professor - department of physical therapy for surgery - Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Actual): November 20, 2021
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Estimated): June 2, 2023

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Pilates exercise ,lung functions ,inhalation injury
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Wounds and Injuries
• Other Study ID Numbers: 341989

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No