Back to resultsPilates Exercises in Patients With Inhalation Injury
Primary Purpose
Inhalation Injury
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pilates exercises
Conventional physical therapy exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Inhalation Injury focused on measuring Pilates exercises, Pulmonary Function, Respiratory Muscle Strength, Functional Capacity Response, Inhalation Injury, Thermal Burn
Eligibility Criteria
Inclusion Criteria: Patients in both sexes and their age will range from 20-50 years. Six weeks after deep second-degree thermal burn with inhalation injury (until complete healing) with 35%-40% total body surface area (TBSA). 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: Participants with a history of regular physical activity (regular exercise habit > 3 times/ week or >150 min/ week) in the last 6 months. Participants with less than an 85% attendance rate at the sessions. 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. Smokers. Pregnant females. Obese participants (BMI > 30 kg/m2). Participants use non-invasive mechanical ventilation and intubation or need for intensive clinical support and/or transfer to the Intensive Care Unit.
Sites / Locations
- Faculty of Physical TherapyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Group A (Pilates Group)
Group B (Control Group)
Arm Description
Participants will receive Pilates exercises for 60 minutes followed by conventional physical therapy program for 45 minutes, 3 days/ week for 12 weeks.
Participants will receive conventional physical therapy program (diaphragmatic deep breathing exercises, bronchial hygiene techniques, assisted cough, stretching exercises and ROM exercises for both upper and lower limbs) for 45 minutes, 3 days/ week for 12 weeks.
Outcomes
Primary Outcome Measures
Forced vital capacity (FVC)
Forced vital capacity (FVC) will be measured by using spirometer
forced expiratory volume in 1 second (FEV1)
forced expiratory volume in 1 second (FEV1) will be measured by using spirometer
peak expiratory flow (PEF)
peak expiratory flow (PEF) will be measured by using spirometer
Secondary Outcome Measures
Respiratory muscle strength
The inspiratory muscle strength will be verified by means of the maximum inspiratory pressure (MIP) and the expiratory muscular strength by means of maximum expiratory pressure (MEP) by using the digital Manovacuometer
Functional capacity
By using 6-Minute Walk Test (6-MWT) that measures the maximum distance walked in a period of 6 min to assess the submaximal level of the functional capacity of the participants
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05988294
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inhalation Injury
Keywords
Pilates exercises, Pulmonary Function, Respiratory Muscle Strength, Functional Capacity Response, Inhalation Injury, Thermal Burn
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A (Pilates Group)
Arm Type
Experimental
Arm Description
Participants will receive Pilates exercises for 60 minutes followed by conventional physical therapy program for 45 minutes, 3 days/ week for 12 weeks.
Arm Title
Group B (Control Group)
Arm Type
Other
Arm Description
Participants will receive conventional physical therapy program (diaphragmatic deep breathing exercises, bronchial hygiene techniques, assisted cough, stretching exercises and ROM exercises for both upper and lower limbs) for 45 minutes, 3 days/ week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Pilates exercises
Intervention Description
One-hour Pilates exercise program was given by a certified trainer to patients three times per week for 12 weeks. The exercise program followed the basic principles of the Pilates method. Our protocol comprised the following components of Pilates-based exercises: strength and stabilization, flexibility and range of motion, proper body alignment, balance, coordination, and body awareness. Resistance bands and 26 cm Pilates balls were used as supportive equipment. The exercise sections consisted of 5 minutes breathing, 10 minutes warm-up, 35 minutes conditioning phase and 10 minutes cool-down.
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy exercise program
Intervention Description
Diaphragmatic deep breathing exercises, bronchial hygiene techniques, assisted cough, stretching exercises and ROM exercises for both upper and lower limbs for 45 minutes, 3 days/ week for 12 weeks.
Primary Outcome Measure Information:
Title
Forced vital capacity (FVC)
Description
Forced vital capacity (FVC) will be measured by using spirometer
Time Frame
12 weeks
Title
forced expiratory volume in 1 second (FEV1)
Description
forced expiratory volume in 1 second (FEV1) will be measured by using spirometer
Time Frame
12 weeks
Title
peak expiratory flow (PEF)
Description
peak expiratory flow (PEF) will be measured by using spirometer
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Respiratory muscle strength
Description
The inspiratory muscle strength will be verified by means of the maximum inspiratory pressure (MIP) and the expiratory muscular strength by means of maximum expiratory pressure (MEP) by using the digital Manovacuometer
Time Frame
12 weeks
Title
Functional capacity
Description
By using 6-Minute Walk Test (6-MWT) that measures the maximum distance walked in a period of 6 min to assess the submaximal level of the functional capacity of the participants
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients in both sexes and their age will range from 20-50 years.
Six weeks after deep second-degree thermal burn with inhalation injury (until complete healing) with 35%-40% total body surface area (TBSA).
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:
Participants with a history of regular physical activity (regular exercise habit > 3 times/ week or >150 min/ week) in the last 6 months.
Participants with less than an 85% attendance rate at the sessions.
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.
Smokers.
Pregnant females.
Obese participants (BMI > 30 kg/m2).
Participants use non-invasive mechanical ventilation and intubation or need for intensive clinical support and/or transfer to the Intensive Care Unit.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nesma M Allam, PhD
Phone
+201281968332
Email
dr.nesma2011@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doaa A Elimy, PhD
Organizational Affiliation
Lecturer of basic science, Faculty of Physical Therapy Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Giza
ZIP/Postal Code
12111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nesma M Allam, PhD
Phone
+201281968332
Email
dr.nesma2011@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study results
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
Study protocol
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Pilates Exercises in Patients With Inhalation Injury
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