Pilates Exercises in Patients with Inhalation Injury

NCT05988294 | Completed

• 1 other identifier: P.T.REC/012/004571
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Inhalation Injury

Keywords

Pilates exercises; Pulmonary Function; Respiratory Muscle Strength; Functional Capacity Response; Inhalation Injury; Thermal Burn

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Respiratory muscle strength

  12 weeks

• Functional capacity

  12 weeks

Study Arms (2)

Group A (Pilates Group)

EXPERIMENTAL

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; Other: Conventional physical therapy exercise program

Group B (Control Group)

OTHER

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

Interventions

Pilates exercises 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.

Group A (Pilates Group)

Conventional physical therapy exercise program 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 A (Pilates Group); Group B (Control Group)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, 12111, Egypt

Location

MeSH Terms

Interventions

Exercise Movement Techniques

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Officials

• Doaa A Elimy, PhD

  Lecturer of basic science, Faculty of Physical Therapy Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Study Record Dates

• First Submitted: July 29, 2023
• First Posted: August 14, 2023
• Study Start: July 30, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 30, 2024
• Last Updated: September 20, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 6 months after publication
• Access Criteria: Study protocol

Locations

EG (1)