NCT05886543

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

May 15, 2023

Last Update Submit

May 23, 2023

Conditions

Keywords

Pilates exercise ,lung functions ,inhalation injury

Outcome Measures

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

    one month

Secondary Outcomes (1)

  • Measurement of anthropometric parameters.

    before spirometer test

Study Arms (2)

control group

EXPERIMENTAL

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 therapyBehavioral: Pilates exercise

study group

EXPERIMENTAL

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 therapyBehavioral: Pilates exercise

Interventions

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.

control groupstudy group

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.

control groupstudy group

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy , Cairo university

Giza, Egypt

Location

MeSH Terms

Interventions

Exercise Movement Techniques

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Ali, a

    assist professor - department of physical therapy for surgery - Cairo university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assisst professor

Study Record Dates

First Submitted

May 15, 2023

First Posted

June 2, 2023

Study Start

September 30, 2021

Primary Completion

November 20, 2021

Study Completion

January 30, 2023

Last Updated

June 2, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations