Influence of Manual Diaphragm Release on Pulmonary Functions in Women With COVID-19

June 12, 2023 updated by: mona abd el raouf ghallab, Cairo University

Influence of Manual Diaphragm Release Combined With Conventional Breathing Exercises and Prone Positioning on Pulmonary Functions in Women With COVID-19

Manual noninvasive respiratory techniques gained interest to treat respiratory pathologies related to COVID 19. This study designed to determine the combined effect of manual diaphragmatic release technique with the effect of conventional breathing exercises and prone positioning on pulmonary function parameters (FVC, FEV1, PEF, FEV1/FVC, FEF25, FEF50, FEF75, FEF25/75).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Forty females were randomly assigned to two groups. Group A received manual diaphragm release with conventional breathing exercises and prone positioning. Group B received conventional breathing exercises and prone positioning. Both groups took their prescribed medications. Their ages ranged from 35 to 45 years and with moderate COVID-19 illness. Any cases with mild and severe COVID-19 illness, ICU admission, and chest diseases were excluded.

Main measures: pulmonary function parameters (FVC, FEV1, PEF, FEV1/FVC, FEF25, FEF50, FEF75, FEF25/75).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Giza
      • Multiple Locations, Giza, Egypt, 12613
        • Cairo Univeristy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • women with moderate COVID-19 illness diagnosed by a physician.
  • Patients with o2 saturation >94%Nonsmoker subjects.
  • age ranging from 35-45 years.
  • body mass index from 25 to 34 kg/m2.

Exclusion Criteria:

  • Unstable hemodynamic status.
  • Acute respiratory failure requiring intubation and impaired consciousness.
  • Inability to collaborate with prone positioning with refusal.
  • Change of mental status hindering response to instructions.
  • Poorly controlled hypertension (Mean systolic BP > 140 mmhg and \or diastolic BP > 40 mmhg).
  • Patients who take continuous o2 supplementation.
  • Smoking.
  • Other chest diseases as (COPD-asthma-tuberculosis-cancer).
  • Male patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
they received manual diaphragm release with conventional breathing exercises and prone positioning in addition to their prescribed medications.
Other: manual therapy
manual diaphragmatic release technique combined with breathing exercise
Other: breathing exercise and prone position alone
deep breathing exercise and prone position
Active Comparator: Control group
they received conventional breathing exercises and prone positioning alone in addition to their prescribed medications.
Other: breathing exercise and prone position alone
deep breathing exercise and prone position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
forced vital capacity FVC
Time Frame: pre study and 3 weeks post study for all participants
the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible which is a common breathing test to check lung function.
pre study and 3 weeks post study for all participants
FEV1
Time Frame: pre study and 3 weeks post study for all participants
the maximum amount of air that the subject can forcibly expel during the first second following maximal inhalation
pre study and 3 weeks post study for all participants
PEF
Time Frame: pre study and 3 weeks post study for all participants
show the amount and rate of air that can be forcefully breathed out of the lungs.
pre study and 3 weeks post study for all participants
FEV1/FVC
Time Frame: pre study and 3 weeks post study for all participants
FEV1/FVC, also known as FEV1%) can help distinguish obstructive and restrictive lung diseases.
pre study and 3 weeks post study for all participants
PEF25%
Time Frame: pre study and 3 weeks post study for all participants
Peak expiratory flow at 25% of fvc and the most sensitive measure of airflow in peripheral airways where primary airflow obstruction originates.
pre study and 3 weeks post study for all participants
PEF50%
Time Frame: pre study and 3 weeks post study for all participants
Peak expiratory flow at 50% ofFVC
pre study and 3 weeks post study for all participants
PEF 75%
Time Frame: pre study and 3 weeks post study for all participants
Peak expiratory flow at 75% of FVC
pre study and 3 weeks post study for all participants
PEF 25%/75%
Time Frame: pre study and 3 weeks post study for all participants
Maximum flow rate in the middle 50% of forced expiration.
pre study and 3 weeks post study for all participants

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: mona M ghallab, doctoral, PHD and lecturer of physical therapy for cardiovascular disease and geriatrics,cairo univeristy
  • Study Chair: neveen M nawar, master, master degree of physical therapy for cardiovascular disease and geriatrics, cairo univeristy
  • Study Director: karim I safaan, doctoral, PHD and lecturer of physical therapy for Surgery, cairo univeristy
  • Study Director: kerolous I shehata, doctoral, PHD and lecturer Department of women health/ faculty of physical therapy /cairo university
  • Study Director: Amira I mostafa, doctoral, PHD and Assistant professor of chest disease Faculty of medicine cairo univeristy
  • Study Chair: mona A mohamed, doctoral, PHD and lecturer of physical therapy for cardiovascular disease and geriatrics,cairo univeristy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

June 9, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFT in COVID-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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