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NCT Number: NCT05886543

Pilates Exercise and Inhalation Injury Post Burn

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

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Key information

Conditions

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of physical therapy , Cairo university

Giza, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional chest physical therapy

Behavioral

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.

Pilates Exercise

Behavioral

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 outcomes

  1. Measurement of Pulmonary Function (spirometry)

    Time frame: one month

    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 outcomes

  1. Measurement of anthropometric parameters.

    Time frame: before spirometer test

    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

Sponsors and collaborators

Lead sponsor

Khadra Mohamed Ali

Other

Collaborators

  • Cairo University

Registry information

Official study title

Pilates Exercise and Lung Functions in Postburn Inhalation Injury Patients.

Acronym: burn

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Jun 2, 2023
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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