Effect of Incentive Spirometery on Asthmatic Pregnant Women

June 12, 2023 updated by: Eman Amin Soliman, Cairo University
The purpose of this study is to determine the effect of the incentive spirometer on asthma during pregnancy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will provide an evidence basis for obstetricians and physical therapist for women's health about the effect of spirometry on asthma during pregnancy.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Dokki, Egypt
        • Outpatient clinic faculty of physical therapy cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

The patients will have the following criteria:

  1. Their age will range from 30 to40years old.
  2. Body mass index (BMI) will range from 25-29.9 kg/m2.
  3. All patients will be clinically and medically stable.

Exclusion Criteria:

Patients will be excluded from the study if they have the following:

  1. Diabetes mellitus.
  2. Severe hypertension.
  3. Neurological and neuromuscular disorders.
  4. Blindness.
  5. Developed moderate and severe degree of pleural effusion.
  6. Cardiovascular instability.
  7. Chronic chest disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pulmicort inhaler
Group (A) consists of 30 patients. They will receive their inhaled glucocorticoids (pulmicort inhaler) on needs.
Drug: pulmicort inhaler
Each woman in both groups (A&B) will receive pulmicort inhaler on needs.
Experimental: incentive spirometer
Group (B) consists of 30 patients. They will receive the same medical treatment and incentive spirometer program 3 days per week for six weeks.
Drug: pulmicort inhaler
Each woman in both groups (A&B) will receive pulmicort inhaler on needs.
Device: Incentive spirometer treatment
Each patient in group B will be instructed about the effects of incentive spirometer to gain their cooperation during the study course.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing the change in lung functions
Time Frame: at baseline and after 6 weeks of intervention
The spirometer will be used for assessment of lung functions including total lung capacity (TLC) (litre), which is the most widely used functional index in the asthma follow up.
at baseline and after 6 weeks of intervention
Assessing the change in symptoms of asthma
Time Frame: at baseline and after 6 weeks of intervention
The Asthma Control Test provides a numerical score to help you and your healthcare provider determine if your asthma symptoms are well controlled. Take this test if you are 12 years or older. Share the score with your healthcare provider.
at baseline and after 6 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2020

Primary Completion (Actual)

September 15, 2021

Study Completion (Actual)

February 15, 2022

Study Registration Dates

First Submitted

June 2, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Eman_Amin_2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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