NCT06518759

Brief Summary

This study will be conducted to compare between the effect of glossopharyngeal and diaphragmatic breathing exercises on pulmonary functions after decortication surgery

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 Jul 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

July 30, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

April 17, 2025

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

July 17, 2024

Last Update Submit

April 14, 2025

Conditions

Outcome Measures

Primary Outcomes (8)

  • Tidal volume

    The spirometer device (Meditech, made in China) will be used to measure tidal volume for all participants in all groups before and after the treatment program. It is the amount of air that moves in or out of the lungs with each respiratory cycle. It measures about 400 ml in a healthy female.

    within 2 weeks

  • Inspiratory reserve volume (IRV)

    The spirometer device (Meditech, made in China) will be used to measure inspiratory reserve volume (IRV) for all participants in all groups before and after the treatment program. \- IRV: It is the amount of air that can be forcibly inhaled after normal tidal volume. The normal adult value is 1900-3300 ml.

    within 2 weeks

  • Expiratory reserve volume (ERV)

    The spirometer device (Meditech, made in China) will be used to measure expiratory reserve volume (ERV) for all participants in all groups before and after the treatment program. ERV: It is the amount of extra air above normal breath-exhaled during forceful breath out, its average is about 800ml in females.

    within 2 weeks

  • Measurement of the potential of hydrogen (PH)

    Blood gas analyzer will be used to measure the potential of hydrogen (PH) for all participants in all groups before and after the treatment program. The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device. The normative value of pH is7.35-7.45

    within 2 weeks

  • Measurement of the partial arterial pressure of carbon dioxide(PaCO2)

    Blood gas analyzer will be used to measure the partial arterial pressure of carbon dioxide(PaCO2) for all participants in all groups before and after the treatment program. The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device. the normative value of PaCO2 is 4.7-6 KPa.

    within 2 weeks

  • Measurement of the partial arterial pressure of oxygen (PaO2)

    Blood gas analyzer will be used to measure the partial arterial pressure of oxygen (PaO2)for all participants in all groups before and after the treatment program. The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device. the normative value of Pao2 is 1.7-13.3 KPa.

    within 2 weeks

  • Measurement of the Bicarbonate (HCO3)

    Blood gas analyzer will be used to measure the Bicarbonate (HCO3) for all participants in all groups before and after the treatment program. The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device. The normative value of HCO3 is 22-26 mmol/L.

    within 2 weeks

  • Measurement of oxygen saturation (SO2)

    Blood gas analyzer will be used to measure oxygen saturation (SO2) for all participants in all groups before and after the treatment program. The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device. The normative value of SO2 is 95-100%..

    within 2 weeks

Study Arms (3)

Traditional chest techniques

ACTIVE COMPARATOR

the patients will receive traditional chest techniques only

Other: traditional chest techniques

Traditional chest techniques +Glossopharyngeal breathing exercise

EXPERIMENTAL

the patients will receive traditional chest techniques and glossopharyngeal breathing exercise

Other: traditional chest techniquesOther: Glossopharyngeal breathing exercise

Traditional chest techniques +diaphragmatic breathing exercise

EXPERIMENTAL

the patients will receive traditional chest techniques and diaphragmatic breathing exercise

Other: traditional chest techniquesOther: Diaphragmatic breathing exercise

Interventions

patients will receive traditional chest techniques in the form of percussion and vibration, 2 times per day, 3 sets 5 repetitions per each set for 20 minutes, 3 times per week for 2 weeks

Traditional chest techniquesTraditional chest techniques +Glossopharyngeal breathing exerciseTraditional chest techniques +diaphragmatic breathing exercise

patients will receive Glossopharyngeal breathing exercise, 2 times per day, 3 sets 5 repetitions per each set for 20 minutes, 3 times per week for 2 weeks.

Traditional chest techniques +Glossopharyngeal breathing exercise

patients will receive diaphragmatic breathing exercise, 2 times per day, 3 sets 5 repetitions per each set for 20 minutes, 3 times per week for 2 weeks.

Traditional chest techniques +diaphragmatic breathing exercise

Eligibility Criteria

Age40 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The participant's body mass index (BMI) will be ranged from 25- 29.9 kg/m2
  • The patient will receive treatment after 24 hours after decortication
  • The study will be in the intensive care unit (ICU).
  • The patients have unilateral lung decortication
  • Their vital capacity is 70% or less.

You may not qualify if:

  • Cancerous patient.
  • Inability to comprehend and follow instructions as in dementia
  • paralytic involvement of thorax muscle
  • Abdominal diseases that affect diaphragmatic function
  • Diaphragmatic paralysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mai Gamal El-Din Mostafa

Cairo, Egypt

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Nesreen El-Nahas, professor

    Cairo University

    STUDY CHAIR

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
Principal investigator

Study Record Dates

First Submitted

July 17, 2024

First Posted

July 24, 2024

Study Start

July 30, 2024

Primary Completion

March 15, 2025

Study Completion

March 31, 2025

Last Updated

April 17, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations