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CompletedNCT05886543burnUpdated Jun 2, 2023

Pilates Exercise and Inhalation Injury Post Burn

An interventional study of Conventional chest physical therapy and Pilates exercise in Inhalation Injury, sponsored by Khadra Mohamed Ali. Completed at 1 site in Egypt. Open to participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-06-02.

Sponsored by Khadra Mohamed Ali · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Sep 2021, registered May 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
All
01

Study summary

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

Read the detailed description

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
02

Conditions studied

  • Inhalation Injury

Keywords

  • Pilates exercise ,lung functions ,inhalation injury
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's enrollment of 60 is above the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Khadra Mohamed Ali is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Cardiac diseases.
  • Chronic pulmonary disorders.
  • Previous or present smoking history.
  • Female patients who are pregnant and lactating.
  • Post-burn patient on ICU.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    control group

    this group includes 30 patients who have post burn inhalation injury will receive 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

    Behavioral: Conventional chest physical therapy · Behavioral: Pilates exercise

  • Experimental
    study group

    this group includes 30 patients who have post burn inhalation injury 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.omputerized 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

    Behavioral: Conventional chest physical therapy · Behavioral: Pilates exercise

Interventions

  • BehavioralConventional chest physical therapy

    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.

  • BehavioralPilates exercise

    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.

06

What researchers measure

Primary outcomes

  1. Measurement of Pulmonary Function (spirometry)

    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

    Time frame: one month

Secondary outcomes

  1. Measurement of anthropometric parameters.

    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

    Time frame: before spirometer test

07

Study locations

1 site
  • faculty of physical therapy , Cairo university
    Giza, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05886543
Lead sponsor
Khadra Mohamed Ali
Collaborators
Cairo University
Responsible party
Khadra Mohamed Ali (assisst professor, Cairo University) — Sponsor-investigator
First posted
Jun 2, 2023
Start date
Sep 30, 2021
Primary completion
Nov 20, 2021
Completion
Jan 30, 2023
Last update
Jun 2, 2023

Study contacts

Ali, a
principal investigator · assist professor - department of physical therapy for surgery - Cairo university

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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