burn: Pilates Exercise and Inhalation Injury Post Burn

Sponsor

Khadra Mohamed Ali (Other)

Overall Status

Completed

CT.gov ID

NCT05886543

Collaborator

Cairo University (Other)

Enrollment

Location

Arms

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Inhalation Injury	Behavioral: Conventional chest physical therapy Behavioral: Pilates exercise	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Pilates Exercise and Lung Functions in Postburn Inhalation Injury Patients.

Actual Study Start Date :

Sep 30, 2021

Actual Primary Completion Date :

Nov 20, 2021

Actual Study Completion Date :

Jan 30, 2023

Arms and Interventions

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.

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

Behavioral: Pilates exercise

Outcome Measures

Primary Outcome Measures

Measurement of Pulmonary Function (spirometry) [one month]
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

Secondary Outcome Measures

Measurement of anthropometric parameters. [before spirometer test]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of physical therapy , Cairo university	Giza		Egypt

Sponsors and Collaborators

Khadra Mohamed Ali
Cairo University

Investigators

Principal Investigator: Ali, a, assist professor - department of physical therapy for surgery - Cairo university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Khadra Mohamed Ali, assisst professor, Cairo University

ClinicalTrials.gov Identifier:

NCT05886543

Other Study ID Numbers:

341989

First Posted:

Jun 2, 2023

Last Update Posted:

Jun 2, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Khadra Mohamed Ali, assisst professor, Cairo University

Pilates exercise ,lung functions ,inhalation injury

Additional relevant MeSH terms:

Respiratory Aspiration

Wounds and Injuries

Study Results

No Results Posted as of Jun 2, 2023