Lung Functions in Menopausal Obese Women After COVID 19 Recovery

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05008991
• Other study ID #: Hend 2
• Status: Completed
• Start date: July 20, 2021
• Est. completion date: October 20, 2021

Study information

• Verified date: November 2021
• Source: Badr University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Lung Function Decreased
• Menopause
• Obesity

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy, Badr University	Cairo	New Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Badr University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	FEV1 will be measured after 1 month post COVID19 recovery.
Primary	forced vital capacity (FVC)	is the total amount of air exhaled during the FEV test.	FVC will be measured after 1 month post COVID19 recovery.
Primary	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.	FEV1/FVC ratio will be measured after 1 month post COVID19 recovery.