Pilates Exercises in Patients with Inhalation Injury

NCT ID: NCT05988294

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-30
• Study Completion Date: 2024-05-30

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.

Conditions

Inhalation Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pilates exercises

Intervention Type: OTHER

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.

Conventional physical therapy exercise program

Intervention Type: OTHER

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.

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.

Group Type: OTHER

Conventional physical therapy exercise program

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nesma Morgan Allam

Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doaa A Elimy, PhD

Role: STUDY_DIRECTOR

Lecturer of basic science, Faculty of Physical Therapy Cairo University

Locations

Faculty of Physical Therapy

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004571

Identifier Type: -

Identifier Source: org_study_id