Effect of Incentive Spirometery on Asthmatic Pregnant Women

Not Applicable

Completed

• Conditions: Asthmatic; Pregnant With Complication
• Interventions: Drug: pulmicort inhaler; Device: Incentive spirometer treatment

• Registration Number: NCT05904002
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study Start: 2020-09-20
• Primary Completion: 2021-09-15
• Study Completion: 2022-02-15
• Status Verified: 2023-06
• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-06-12
• Last Update Submitted: 2023-06-12
• Study First Posted: 2023-06-15
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pulmicort inhaler	pulmicort inhaler	Group (A) consists of 30 patients. They will receive their inhaled glucocorticoids (pulmicort inhaler) on needs.
incentive spirometer	pulmicort inhaler	Group (B) consists of 30 patients. They will receive the same medical treatment and incentive spirometer program 3 days per week for six weeks.
incentive spirometer	Incentive spirometer treatment	Group (B) consists of 30 patients. They will receive the same medical treatment and incentive spirometer program 3 days per week for six weeks.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Outpatient clinic faculty of physical therapy cairo university; 🇪🇬 Dokki, Egypt