Lung Functions in Menopausal Obese Women After COVID 19 Recovery

NCT ID: NCT05008991

Last Updated: 2021-11-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-20
• Study Completion Date: 2021-10-20

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.

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

Keywords

Lung funnctions; Menopause; Obesity; Covid19

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Study group

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

Spirometry

Intervention Type: DEVICE

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.

Spirometry

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Badr University

OTHER

Sponsor Role: lead

Responsible Party

Hend Reda Sakr

Lecturer at Department of Physical Therapy for Woman's Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariam El Ebrashy, PhD

Role: PRINCIPAL_INVESTIGATOR

Badr University in Cairo

Locations

Faculty of Physical Therapy, Badr University

Cairo, New Cairo, Egypt

Countries

Egypt

Other Identifiers

Hend 2

Identifier Type: -

Identifier Source: org_study_id