Lung Functions in Menopausal Obese Women After COVID 19 Recovery

NCT05008991 | Completed DMC

• 1 other identifier: Hend 2
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Function Decreased; Obesity; Menopause; Covid19

Keywords

Lung funnctions; Menopause; Obesity; Covid19

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (2)

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

Control group

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

Device: Spirometry

Interventions

Spirometry 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; Study group

Eligibility Criteria

• Age: 45 Years - 55 Years
• Gender Eligibility Details: Female menopausal women only.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Badr University: lead

Study Sites (1)

Faculty of Physical Therapy, Badr University

Cairo, New Cairo, 11829, Egypt

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Obesity; COVID-19

Interventions

Spirometry

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mariam El Ebrashy, PhD

  Badr University in Cairo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at Department of Physical Therapy for Woman's Health

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 17, 2021
• Study Start: July 20, 2021
• Primary Completion: September 20, 2021
• Study Completion: October 20, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-11

Locations

EG (1)