Post COVID-19 PatientsNCT05977166
Hyperbaric on Pulmonary Functions in Post Covid -19 Patients.
A study testing hyperbaric oxygen therapy, breathing exercise and medical treatment in people with Post COVID-19 Patients, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 66 years
- Conditions the study is for
- Post COVID-19 Patients
- What is being tested?
- hyperbaric oxygen therapy, breathing exercise and medical treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Mar 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- COPD or other respiratory diseases.
- Neurological disease.
- mental illness.
- Critically ill patients with intubation.
- smokers.
- Inner ear diseases.
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Hyperbaric Oxygen 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.
Read more
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.
- Conditions
- Post COVID-19 Patients
- Being tested
- hyperbaric oxygen therapy, breathing exercise, medical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric oxygen therapyDevice
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 exerciseDevice
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 treatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| hyperbaric oxygen therapy ,breathing exercise,medical treatment | Active comparator | 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. Receives: Device: hyperbaric oxygen therapy; Device: breathing exercise; Drug: medical treatment |
| breathing exercise and medical treatment | Active comparator | 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 Receives: Device: hyperbaric oxygen therapy; Device: breathing exercise; Drug: medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
forced vital capacity,
by spirometer
Measured: 3 Months
forced expiratory volume
by spirometer
Measured: 3 Months
oxygen saturation
pulse oximeter
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start7 Mar 2022
- Primary completion21 Jun 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID-19 PatientsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Faraman Mohamed, Cairo University
- Investigators
- Enas Faraman, Principal investigator, physiothyrapist at kafer Elshikh general Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977166
- Sponsor's protocol ID
- P.T.REL/012/003546
- Status last verified
- Aug 2023
- First submitted
- 11 Jun 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Hyperbaric Oxygen on Pulmonary Functions in Post Covid-19 Patients.
- ClinicalTrials.gov ID
- NCT05977166
- Acronym / sponsor ID
- P.T.REL/012/003546
- Conditions
- Post COVID-19 Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperbaric oxygen therapy ,breathing exercise,medical treatment | Active comparator | Device: hyperbaric oxygen therapy, Device: breathing exercise, Drug: medical treatmentHyperbaric 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 and medical treatment | Active comparator | Device: hyperbaric oxygen therapy, Device: breathing exercise, Drug: medical treatmentbreathing 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 |
Who may qualify
- Ages
- 21 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- COPD or other respiratory diseases.
- Neurological disease.
- mental illness.
- Critically ill patients with intubation.
- smokers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperbaric oxygen therapyAll 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. | Device | breathing exercise and medical treatment, hyperbaric oxygen therapy ,breathing exercise,medical treatment |
| breathing exerciseAll 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. | Device | breathing exercise and medical treatment, hyperbaric oxygen therapy ,breathing exercise,medical treatment |
| medical treatmentAll 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. | Drug | breathing exercise and medical treatment, hyperbaric oxygen therapy ,breathing exercise,medical treatment |
Primary outcome
forced vital capacity,
Time frame: 3 Months
by spirometer
forced expiratory volume
Time frame: 3 Months
by spirometer
oxygen saturation
Time frame: 3 Months
pulse oximeter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enas Faraman principal investigator
physiothyrapist at kafer Elshikh general Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperbaric oxygen therapy, breathing exercise and medical treatment in people with Post COVID-19 Patients, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
forced vital capacity, (time frame: 3 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.