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Hyperbaric on Pulmonary Functions in Post Covid -19 Patients.

Primary Purpose

Post COVID-19 Patients

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
hyperbaric oxygen therapy
breathing exercise
medical treatment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post COVID-19 Patients

Eligibility Criteria

21 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

hyperbaric oxygen therapy ,breathing exercise,medical treatment

breathing exercise and medical treatment

Arm Description

Hyperbaric oxygen treatment HBO treatment was given daily in the morning on 21 consecutive days. (HBOT) treatment is a procedure performed inside a pressured chamber (the Hyperbaric Chamber). The patient is place inside the chamber exposure to 100% oxygen at 2 ATA with 5 min air breaks every 20 min. Each session consisted of 60 min. Measurements will be taken in the morning before entering, the first and last session.

breathing exercise completely each session of three repetitions initially. Every repetition consisted of one round of intervention 10-15 times followed by a brief rest (normal breathing) of <1 min (one repetition). Such 3 repetitions were given initially & advanced till 10 repetitions (one session) by last day of the week. In this manner participants practised 3 sessions twice a day, for a total duration of about 10-20 min every day.Vitamin D: The recommended dietary dose of vitamin D is 600 IU each day . Vitamine C: The recommended dietary dose 200 mg/day vitamin C. Anticoagulation drugs (blood thinners), doctors usually prescribe low-molecular-weight heparin (enoxaparin) (30 mg), each given subcutaneously every 12 hours

Outcomes

Primary Outcome Measures

forced vital capacity,
by spirometer
forced expiratory volume
by spirometer
oxygen saturation
pulse oximeter

Secondary Outcome Measures

Full Information

First Posted
June 11, 2023
Last Updated
August 3, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05977166
Brief Title
Hyperbaric on Pulmonary Functions in Post Covid -19 Patients.
Official Title
Influence of Hyperbaric Oxygen on Pulmonary Functions in Post Covid-19 Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
June 21, 2022 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post COVID-19 Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hyperbaric oxygen therapy ,breathing exercise,medical treatment
Arm Type
Active Comparator
Arm Description
Hyperbaric oxygen treatment HBO treatment was given daily in the morning on 21 consecutive days. (HBOT) treatment is a procedure performed inside a pressured chamber (the Hyperbaric Chamber). The patient is place inside the chamber exposure to 100% oxygen at 2 ATA with 5 min air breaks every 20 min. Each session consisted of 60 min. Measurements will be taken in the morning before entering, the first and last session.
Arm Title
breathing exercise and medical treatment
Arm Type
Active Comparator
Arm Description
breathing exercise completely each session of three repetitions initially. Every repetition consisted of one round of intervention 10-15 times followed by a brief rest (normal breathing) of <1 min (one repetition). Such 3 repetitions were given initially & advanced till 10 repetitions (one session) by last day of the week. In this manner participants practised 3 sessions twice a day, for a total duration of about 10-20 min every day.Vitamin D: The recommended dietary dose of vitamin D is 600 IU each day . Vitamine C: The recommended dietary dose 200 mg/day vitamin C. Anticoagulation drugs (blood thinners), doctors usually prescribe low-molecular-weight heparin (enoxaparin) (30 mg), each given subcutaneously every 12 hours
Intervention Type
Device
Intervention Name(s)
hyperbaric oxygen therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
breathing exercise
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
medical treatment
Intervention Description
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 Outcome Measure Information:
Title
forced vital capacity,
Description
by spirometer
Time Frame
3 Months
Title
forced expiratory volume
Description
by spirometer
Time Frame
3 Months
Title
oxygen saturation
Description
pulse oximeter
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enas Faraman
Organizational Affiliation
physiothyrapist at kafer Elshikh general Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Giza
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Hyperbaric on Pulmonary Functions in Post Covid -19 Patients.

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