Lung Function DecreasedNCT05008991
Lung Functions in Menopausal Obese Women After COVID 19 Recovery
An observational study of Lung Function Decreased and Obesity, run by Badr University at 1 site in Egypt.
Trial summary
The COVID-19 pandemic has presented considerable challenges to global health services and dictates almost every aspect of medical practice and policy. The menopausal transition may have significant consequences for respiratory health as COVID 19 symptoms subsides, lung function testing should be done to assess the… Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lung Function Decreased, Obesity, Menopause
- What is being tested?
- Spirometry
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2021to 20 Oct 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 45 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: all women will be aged from 45 to 55 years old in menopause, their BMI will be from 30 to 34.9 kg/m2.
Who may be able to join
- Participants recovered from mild to moderated signs and symptoms of COVID- 19 after one month.
- Ability to perform pulmonary function tests correctly.
- COVID-19 was diagnosed by positive polymerase chain reaction (PCR) testing on nasopharyngeal swab, oxygen saturation was ranged between 92-96% during illness period.
- CT chest shows ground glass opacity.
- Their D-dimer was less than 0.5 μg/ml.
- Two successive negative PCR were before included in study.
- Participants were in home isolation during illness period.
Who cannot join
- Chronic respiratory disease.
- Chronic heart disease.
- Diabetes mellitus.
- Smoking.
- Centralized isolation.
- Severe COVID-19.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy, Badr University
Cairo, New Cairo, 11829
About this study
Official title: Assessment of Lung Functions in Menopausal Obese Women After COVID 19 Recovery
The COVID-19 pandemic has presented considerable challenges to global health services and dictates almost every aspect of medical practice and policy. The menopausal transition may have significant consequences for respiratory health as COVID 19 symptoms subsides, lung function testing should be done to assess the consequences of this virus on lung health especially in menopausal woman.
Read the detailed description
The study group will consist of (40) obese menopausal women whom were recently recovered from mild-moderate COVID 19 for one month. The control group will consist of (40) obese menopausal women; whom will not affected by COVID 19. Using incentive spirometer, we will measure forced vital capacity FVC, forced expiratory volume FEV, Tiffano index TI and peak expiratory force PEF in both groups.
- Conditions
- Lung Function Decreased, Obesity, Menopause, Covid19
- Being tested
- Spirometry
- Keywords
- Lung funnctions, Menopause, Obesity, Covid19
- Medical subject headings
- Respiratory Insufficiency, Obesity, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirometryDevice
Spirometry assesses the integrated mechanical function of the lung, chest wall, respiratory muscles, and airways by measuring the total volume of air exhaled from a full lung (total lung capacity [TLC]) to maximal expiration (residual volume [RV]). This volume, the forced vital capacity (FVC) and the forced expiratory volume in the first second of the forceful exhalation (FEV1), should be repeatable to within 0.15 L upon repeat efforts in the same measurement unless the largest value for either parameter is less than 1 L. In this case, the expected repeatability is to within 0.1 L of the largest value.
| Study group | Role | What they receive |
|---|---|---|
| Study group | The study group will consist of (20) obese menopausal women whom are recently recovered from mild-moderate COVID-19 after one month. Receives: Device: Spirometry | |
| Control group | The control group will consist of (20) obese menopausal women; whom are not be affected by COVID-19. Receives: Device: Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in the first second (FEV1)
is a measurement of your ability to expel air from your lungs. More specifically, and as its name suggests, it is the amount that is exhaled in the first second of purposefully trying to breathe out as much air as possible.
Measured: FEV1 will be measured after 1 month post COVID19 recovery.
forced vital capacity (FVC)
is the total amount of air exhaled during the FEV test.
Measured: FVC will be measured after 1 month post COVID19 recovery.
FEV1/FVC ratio
The FEV1/FVC ratio, also called Tiffeneau-Pinelli index, is a calculated ratio used in the diagnosis of obstructive and restrictive lung disease. It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration to the full, forced vital capacity.
Measured: FEV1/FVC ratio will be measured after 1 month post COVID19 recovery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start20 Jul 2021
- Primary completion20 Sep 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Function DecreasedStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Reda Sakr, Badr University
- Investigators
- Mariam El Ebrashy, PhD, Principal investigator, Badr University in Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008991
- Sponsor's protocol ID
- Hend 2
- Status last verified
- Nov 2021
- First submitted
- 16 Aug 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Lung Functions in Menopausal Obese Women After COVID 19 Recovery
- ClinicalTrials.gov ID
- NCT05008991
- Acronym / sponsor ID
- Hend 2
- Conditions
- Lung Function Decreased, Obesity, Menopause, Covid19
- Keywords
- Lung funnctions, Menopause, Obesity, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 17 Aug 2021 (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.
The COVID-19 pandemic has presented considerable challenges to global health services and dictates almost every aspect of medical practice and policy. The menopausal transition may have significant consequences for respiratory health as COVID 19 symptoms subsides, lung function testing should be done to assess the consequences of this virus on lung health especially in menopausal woman.
Detailed description
The study group will consist of (40) obese menopausal women whom were recently recovered from mild-moderate COVID 19 for one month. The control group will consist of (40) obese menopausal women; whom will not affected by COVID 19. Using incentive spirometer, we will measure forced vital capacity FVC, forced expiratory volume FEV, Tiffano index TI and peak expiratory force PEF in both groups.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: SpirometryThe study group will consist of (20) obese menopausal women whom are recently recovered from mild-moderate COVID-19 after one month. |
| Control group | – | Device: SpirometryThe control group will consist of (20) obese menopausal women; whom are not be affected by COVID-19. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- all women will be aged from 45 to 55 years old in menopause, their BMI will be from 30 to 34.9 kg/m2.
Key inclusion criteria (7 listed)
- Participants recovered from mild to moderated signs and symptoms of COVID- 19 after one month.
- Ability to perform pulmonary function tests correctly.
- COVID-19 was diagnosed by positive polymerase chain reaction (PCR) testing on nasopharyngeal swab, oxygen saturation was ranged between 92-96% during illness period.
- CT chest shows ground glass opacity.
- Their D-dimer was less than 0.5 μg/ml.
Key exclusion criteria (6 listed)
- Chronic respiratory disease.
- Chronic heart disease.
- Diabetes mellitus.
- Smoking.
- Centralized isolation.
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 |
|---|---|---|
| SpirometrySpirometry assesses the integrated mechanical function of the lung, chest wall, respiratory muscles, and airways by measuring the total volume of air exhaled from a full lung (total lung capacity [TLC]) to maximal expiration (residual volume [RV]). This volume, the forced vital capacity (FVC) and the forced expiratory volume in the first second of the forceful exhalation (FEV1), should be repeatable to within 0.15 L upon repeat efforts in the same measurement unless the largest value for either parameter is less than 1 L. In this case, the expected repeatability is to within 0.1 L of the largest value. | Device | Control group, Study group |
Primary outcome
Forced expiratory volume in the first second (FEV1)
Time frame: FEV1 will be measured after 1 month post COVID19 recovery.
is a measurement of your ability to expel air from your lungs. More specifically, and as its name suggests, it is the amount that is exhaled in the first second of purposefully trying to breathe out as much air as possible.
forced vital capacity (FVC)
Time frame: FVC will be measured after 1 month post COVID19 recovery.
is the total amount of air exhaled during the FEV test.
FEV1/FVC ratio
Time frame: FEV1/FVC ratio will be measured after 1 month post COVID19 recovery.
The FEV1/FVC ratio, also called Tiffeneau-Pinelli index, is a calculated ratio used in the diagnosis of obstructive and restrictive lung disease. It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration to the full, forced vital capacity.
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 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
Mariam El Ebrashy, PhD principal investigator
Badr University in Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Function Decreased and Obesity, run by Badr 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 7 inclusion and 6 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 Nov 2021. 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 expiratory volume in the first second (FEV1) (time frame: FEV1 will be measured after 1 month post COVID19 recovery.). 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 Nov 2021.