NCT07867639

Brief Summary

Pulmonary dysfunction can be developed as a result of complications caused by direct thermal injury to the respiratory tract, smoke irritations, and respiratory tract infection. Although the survival rates of patients with burn injury have increased because of improved acute management, pulmonary complications have continued to be the main cause of mortality in patients with burns. The patients who survive suffer from persistent physiological impairments, limited aerobic capacity, increased skeletal muscle catabolism, and decreased muscle strength/endurance. Rehabilitation strategies for the long-term recovery in patients with burns aim to improve the physical function and independence in daily activities.

Trial Health

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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
7mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

October 15, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2027

16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

6 months

First QC Date

October 3, 2026

Last Update Submit

October 7, 2026

Conditions

Burn

Keywords

Inspiratory muscle trainingBalancePostural stabilityBurnRespiratory muscle strength

Outcome Measures

Primary Outcomes (1)

  • Respiratory muscle strength (Maximum Inspiratory Pressure)

    Maximum Inspiratory Pressure (MIP): Inspiratory muscle strength will be assessed by measuring the maximum inspiratory pressure (MIP) using a respiratory pressure meter. MIP will be recorded in cmH₂O, with higher values indicating greater inspiratory muscle strength.

    8 weeks

Secondary Outcomes (5)

  • Respiratory muscle strength (Maximum expiratory Pressure)

    8 weeks

  • Balance

    8 weeks

  • Postural stability (Overall Stability Index)

    8 weeks

  • Postural stability (Anterior-Posterior Index)

    8 weeks

  • Postural stability (Mediolateral Index)

    8 weeks

Study Arms (2)

Study group (Inspiratory muscle training)

EXPERIMENTAL

Participants will receive Inspiratory muscle training followed by conventional physical therapy program

Device: Inspiratory muscle trainingOther: Conventional physical therapy

Control group

ACTIVE COMPARATOR

Participants will receive conventional physical therapy program (respiratory physical therapy, balance and aerobic exercises)

Other: Conventional physical therapy

Interventions

Inspiratory muscle trainingDEVICE

Participants in the experimental group will receive Inspiratory muscle training device, in addition to conventional physical therapy program. Initially, participants will be asked to perform three sets of 30 breaths on the POWER breathe to adjust the load and become familiar with the device. The training will include six 30-breath sets each day, divided into two sessions each. There is a one-minute rest time between each set. The inspiratory muscle load for training will be 50% of maximum inspiratory pressure (MIP), and it will be reviewed and changed weekly.

Study group (Inspiratory muscle training)
Conventional physical therapyOTHER

Conventional physical therapy exercise program in the form of respiratory physical therapy, balance and aerobic exercises.

Control groupStudy group (Inspiratory muscle training)

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants with inhalation injury after thermal burn injury including face and chest
  • with 40-60 % of total body surface area (%TBSA)
  • Partial or full thickness burns that either recovered spontaneously or healed by skin grafting
  • Age (20-50) years.

You may not qualify if:

  • Cerebrovascular disease
  • Heavy smokers
  • Open or unhealed wounds
  • Chest physical therapy before enrollment
  • Any lung disorders (COPD or asthma)
  • musculoskeletal impairment
  • Neurological impairment
  • Cardiac diseases
  • Cognitive disorders
  • Obese individuals BMI ≥ 30 kg/m2
  • Pregnant females
  • Participants in intensive care unit who are intubated and depend on mechanical ventilation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Nesma M Allam, PhD

CONTACT

01281968332dr.nesma2011@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, Faculty of physical therapy

Study Record Dates

First Submitted

October 3, 2026

First Posted

October 9, 2026

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

EG(1)