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Completed

NCT Number: NCT05008991

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.

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Key information

Conditions

Lung Function Decreased Body Weight COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Menopause Nidovirales Infections Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

45 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Faculty of Physical Therapy, Badr University

Cairo, New Cairo, 11829, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Badr University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2021
Registry last updated
Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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