search
Back to results

Pilates Exercise and Inhalation Injury Post Burn (burn)

Primary Purpose

Inhalation Injury

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Conventional chest physical therapy
Pilates exercise
Sponsored by
Khadra Mohamed Ali
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inhalation Injury focused on measuring Pilates exercise ,lung functions ,inhalation injury

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • faculty of physical therapy , Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

control group

study group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 15, 2023
Last Updated
May 23, 2023
Sponsor
Khadra Mohamed Ali
Collaborators
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT05886543
Brief Title
Pilates Exercise and Inhalation Injury Post Burn
Acronym
burn
Official Title
Pilates Exercise and Lung Functions in Postburn Inhalation Injury Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
November 20, 2021 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Khadra Mohamed Ali
Collaborators
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inhalation Injury
Keywords
Pilates exercise ,lung functions ,inhalation injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Experimental
Arm Description
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
Arm Title
study group
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Conventional chest physical therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pilates exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of Pulmonary Function (spirometry)
Description
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
Time Frame
one month
Secondary Outcome Measure Information:
Title
Measurement of anthropometric parameters.
Description
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
Time Frame
before spirometer test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali, a
Organizational Affiliation
assist professor - department of physical therapy for surgery - Cairo university
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of physical therapy , Cairo university
City
Giza
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pilates Exercise and Inhalation Injury Post Burn

We'll reach out to this number within 24 hrs