Lung Functions in Menopausal Obese Women After COVID 19 Recovery

Sponsor

Badr University (Other)

Overall Status

Completed

CT.gov ID

NCT05008991

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

13.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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 consequences of this virus on lung health especially in menopausal woman.

Condition or Disease	Intervention/Treatment	Phase
Lung Function Decreased Obesity Menopause Covid19	Device: Spirometry

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

Study Type:

Observational [Patient Registry]

Actual Enrollment :

40 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Assessment of Lung Functions in Menopausal Obese Women After COVID 19 Recovery

Actual Study Start Date :

Jul 20, 2021

Actual Primary Completion Date :

Sep 20, 2021

Actual Study Completion Date :

Oct 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Study group The study group will consist of (20) obese menopausal women whom are recently recovered from mild-moderate COVID-19 after one month.	Device: Spirometry 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.
Control group The control group will consist of (20) obese menopausal women; whom are not be affected by COVID-19.	Device: Spirometry 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.

Arm

Intervention/Treatment

Study group

The study group will consist of (20) obese menopausal women whom are recently recovered from mild-moderate COVID-19 after one month.

Device: Spirometry

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.

Control group

The control group will consist of (20) obese menopausal women; whom are not be affected by COVID-19.

Device: Spirometry

Outcome Measures

Primary Outcome Measures

Forced expiratory volume in the first second (FEV1) [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) [FVC will be measured after 1 month post COVID19 recovery.]
is the total amount of air exhaled during the FEV test.
FEV1/FVC ratio [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

Chronic respiratory disease.
Chronic heart disease.
Diabetes mellitus.
Smoking.
Centralized isolation.
Severe COVID-19.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Physical Therapy, Badr University	Cairo	New Cairo	Egypt	11829

Sponsors and Collaborators

Badr University

Investigators

Principal Investigator: Mariam El Ebrashy, PhD, Badr University in Cairo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hend Reda Sakr, Lecturer at Department of Physical Therapy for Woman's Health, Badr University

ClinicalTrials.gov Identifier:

NCT05008991

Other Study ID Numbers:

Hend 2

First Posted:

Aug 17, 2021

Last Update Posted:

Nov 4, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hend Reda Sakr, Lecturer at Department of Physical Therapy for Woman's Health, Badr University

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Nov 4, 2021