Pilates Exercises in Patients with Inhalation Injury

Pulmonary Function, Respiratory Muscle Strength and Functional Capacity Response to Pilates Exercises in Patients with Inhalation Injury After Thermal Burn.

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.

Study Overview

• Status: Completed
• Conditions: Inhalation Injury
• Intervention / Treatment: Other: Pilates exercises; Other: Conventional physical therapy exercise program

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.

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

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12111
    • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Patients in both sexes and their age will range from 20-50 years.
2. Six weeks after deep second-degree thermal burn with inhalation injury (until complete healing) with 35%-40% total body surface area (TBSA).
3. 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:

1. Participants with a history of regular physical activity (regular exercise habit > 3 times/ week or >150 min/ week) in the last 6 months.
2. Participants with less than an 85% attendance rate at the sessions.
3. 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.
4. Smokers.
5. Pregnant females.
6. Obese participants (BMI > 30 kg/m2).
7. Participants use non-invasive mechanical ventilation and intubation or need for intensive clinical support and/or transfer to the Intensive Care Unit.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (Pilates Group); Participants will receive Pilates exercises for 60 minutes followed by conventional physical therapy program for 45 minutes, 3 days/ week for 12 weeks.	Other: Pilates exercises; 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.; Other: Conventional physical therapy exercise 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.
Other: Group B (Control Group); 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.	Other: Conventional physical therapy exercise 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced vital capacity (FVC)	Forced vital capacity (FVC) will be measured by using spirometer	12 weeks
forced expiratory volume in 1 second (FEV1)	forced expiratory volume in 1 second (FEV1) will be measured by using spirometer	12 weeks
peak expiratory flow (PEF)	peak expiratory flow (PEF) will be measured by using spirometer	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 weeks
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	12 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Doaa A Elimy, PhD, Lecturer of basic science, Faculty of Physical Therapy Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: July 29, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Pulmonary Function; Pilates exercises; Respiratory Muscle Strength; Thermal Burn; Functional Capacity Response; Inhalation Injury
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Wounds and Injuries
• Other Study ID Numbers: P.T.REC/012/004571

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study results
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: Study protocol
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No