Effect of Incentive Spirometery on Asthmatic Pregnant Women

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT05904002

Collaborator

(none)

Enrollment

Location

Arms

16.9

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effect of the incentive spirometer on asthma during pregnancy.

Condition or Disease	Intervention/Treatment	Phase
Asthmatic Pregnant With Complication	Drug: pulmicort inhaler Device: Incentive spirometer treatment	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Effect of Incentive Spirometery on Asthmatic Pregnant Women

Actual Study Start Date :

Sep 20, 2020

Actual Primary Completion Date :

Sep 15, 2021

Actual Study Completion Date :

Feb 15, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Assessing the change in lung functions [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.
Assessing the change in symptoms of asthma [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

The patients will have the following criteria:

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

Exclusion Criteria:

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

Diabetes mellitus.
Severe hypertension.
Neurological and neuromuscular disorders.
Blindness.
Developed moderate and severe degree of pleural effusion.
Cardiovascular instability.
Chronic chest disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Outpatient clinic faculty of physical therapy cairo university	Dokki		Egypt

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eman Amin Soliman, Principal Investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT05904002

Other Study ID Numbers:

Eman_Amin_2023

First Posted:

Jun 15, 2023

Last Update Posted:

Jun 15, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Asthma

Pregnancy Complications

Budesonide

Study Results

No Results Posted as of Jun 15, 2023