Effect of Incentive Spirometery on Asthmatic Pregnant Women

NCT05904002 | Completed DMC

• 1 other identifier: Eman_Amin_2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthmatic; Pregnant With Complication

Outcome Measures

Primary Outcomes (2)

• Assessing the change in lung functions

  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

  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

Study Arms (2)

pulmicort inhaler

EXPERIMENTAL

Group (A) consists of 30 patients. They will receive their inhaled glucocorticoids (pulmicort inhaler) on needs.

Drug: pulmicort inhaler

incentive spirometer

EXPERIMENTAL

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; Device: Incentive spirometer treatment

Interventions

pulmicort inhaler DRUG

Each woman in both groups (A\&B) will receive pulmicort inhaler on needs.

incentive spirometer; pulmicort inhaler

Incentive spirometer treatment DEVICE

Each patient in group B will be instructed about the effects of incentive spirometer to gain their cooperation during the study course.

incentive spirometer

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Outpatient clinic faculty of physical therapy cairo university

Dokki, Egypt

Location

MeSH Terms

Conditions

Asthma; Pregnancy Complications

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 15, 2023
• Study Start: September 20, 2020
• Primary Completion: September 15, 2021
• Study Completion: February 15, 2022
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

EG (1)