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Completed

NCT Number: NCT05903144

Influence of Manual Diaphragm Release 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).

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Key information

Conditions

COVID-19 Pneumonia COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

35 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo Univeristy

Multiple Locations, Giza Governorate, 12613, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual therapy

Other

manual diaphragmatic release technique combined with breathing exercise

breathing exercise and prone position alone

Other

deep breathing exercise and prone position

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. PEF50%

    Time frame: pre study and 3 weeks post study for all participants

    Peak expiratory flow at 50% ofFVC

  7. PEF 75%

    Time frame: pre study and 3 weeks post study for all participants

    Peak expiratory flow at 75% of FVC

  8. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 15, 2023
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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