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Completed

NCT Number: NCT05977166

Hyperbaric on Pulmonary Functions in Post Covid -19 Patients.

Purpose of the study is to investigate the effect of hyperbaric oxygen on FVC, FEV1 and on oxygen saturation in post-COVID-19 patients, The effect of breathing exercises in form of diaphragmatic breathing exercise and pursed lip breathing with traditional medical treatment in form of (vitamin D, vitamin C and anticoagulation drugs on FVC, FEV1 and on oxygen saturation in post-COVID-19 patients.and the difference between the effect of hyperbaric and breathing exercises in form of diaphragmatic breathing exercise and pursed lip breathing with traditional medical treatment in form of (vitamin D, vitamin C and anticoagulation drugs on FVC, FEV1 and on oxygen saturation in post-COVID-19 patients

Seventy two covid-19 patients from both genders ranged in age chronology from twenty one to sixty six years will be conducted to participate in this study .Selection of the study sample and evaluate of pulmonary functions improvement as well as hyperbaric oxygen therapy will be conducted at Agriculture Hospital in El Mansoura town.

The study sample will be divided randomly into two equal groups of(A&B).All patients participated in the current study will receive breathing excesses in form of Diaphragmatic breathing exercise and Pursed lip breathing with traditional medical treatment in form of (vitamin D, vitamin C and Anticoagulation drugs ,group A will receive 60 minutes of HBOT(100%oxygen at 2 ATA with five minutes air breaks every twenty minutes daily in morning for three weeks then take period time of rest about 30 minutes before starting breathing exercise.

The Body mass index (BMI) of each participated patient will be determined by measuring weight/ Kg and height/ m2 using Electronic weight and height scale to include BMI 25.0-29.9 Kg/ . Also using Digital spirometer SMP 21/01 RD (Russian) for measuring of FVC parameters , to be less than 80% ,FEV1 to be less than 80% and Pulse Oximeter for measuring Oxygen saturation to range from 90%to 95% assessment will be done before and after treatment.

The obtained results of this study will measure Forced vital capacity (FVC), Forced expiratory volume (FEV1) and oxygen saturation to determine the significant improvement of participated patients.

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Key information

Age range

21 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Giza, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. post Covid -19 patients (2weeks after recovery).

2.post Covid -19 patients with deficiency in forced vital capacity (less than 80%) forced expiratory volume (less than 80%) lower oxygen saturation (90%-95%).

3.age (21-66)years old.

4.both gender.

5.BMI 25.0-29.9.

Exclusion criteria

  • COPD or other respiratory diseases.
  • Neurological disease.
  • mental illness.
  • Critically ill patients with intubation.
  • smokers.
  • Inner ear diseases.
  • pregnancy.

Treatment and study plan

hyperbaric oxygen therapy

Device

All patients participated in the current study will receive breathing excesses in form of Diaphragmatic breathing exercise and Pursed lip breathing with traditional medical treatment in form of (vitamin D, vitamin C and Anticoagulation drugs ,group A will receive 60 minutes of HBOT(100%oxygen at 2 ATA with five minutes air breaks every twenty minutes daily in morning for three weeks then take period time of rest about 30 minutes before starting breathing exercise.

breathing exercise

Device

All patients participated in the current study will receive breathing excesses in form of Diaphragmatic breathing exercise and Pursed lip breathing with traditional medical treatment in form of (vitamin D, vitamin C and Anticoagulation drugs ,group A will receive 60 minutes of HBOT(100%oxygen at 2 ATA with five minutes air breaks every twenty minutes daily in morning for three weeks then take period time of rest about 30 minutes before starting breathing exercise.

medical treatment

Drug

All patients participated in the current study will receive breathing excesses in form of Diaphragmatic breathing exercise and Pursed lip breathing with traditional medical treatment in form of (vitamin D, vitamin C and Anticoagulation drugs ,group A will receive 60 minutes of HBOT(100%oxygen at 2 ATA with five minutes air breaks every twenty minutes daily in morning for three weeks then take period time of rest about 30 minutes before starting breathing exercise.

Primary outcomes

  1. forced vital capacity,

    Time frame: 3 Months

    by spirometer

  2. forced expiratory volume

    Time frame: 3 Months

    by spirometer

  3. oxygen saturation

    Time frame: 3 Months

    pulse oximeter

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Influence of Hyperbaric Oxygen on Pulmonary Functions in Post Covid-19 Patients.

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 4, 2023
Registry last updated
Aug 4, 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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