Back to resultsEffect of Incentive Spirometery on Asthmatic Pregnant Women
Primary Purpose
Asthmatic, Pregnant With Complication
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pulmicort inhaler
Incentive spirometer treatment
Sponsored by
About this trial
This is an interventional treatment trial for Asthmatic
Eligibility Criteria
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.
Sites / Locations
- Outpatient clinic faculty of physical therapy cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
pulmicort inhaler
incentive spirometer
Arm Description
Group (A) consists of 30 patients. They will receive their inhaled glucocorticoids (pulmicort inhaler) on needs.
Group (B) consists of 30 patients. They will receive the same medical treatment and incentive spirometer program 3 days per week for six weeks.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05904002
Brief Title
Effect of Incentive Spirometery on Asthmatic Pregnant Women
Official Title
Effect of Incentive Spirometery on Asthmatic Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
February 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthmatic, Pregnant With Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pulmicort inhaler
Arm Type
Experimental
Arm Description
Group (A) consists of 30 patients. They will receive their inhaled glucocorticoids (pulmicort inhaler) on needs.
Arm Title
incentive spirometer
Arm Type
Experimental
Arm Description
Group (B) consists of 30 patients. They will receive the same medical treatment and incentive spirometer program 3 days per week for six weeks.
Intervention Type
Drug
Intervention Name(s)
pulmicort inhaler
Intervention Description
Each woman in both groups (A&B) will receive pulmicort inhaler on needs.
Intervention Type
Device
Intervention Name(s)
Incentive spirometer treatment
Intervention Description
Each patient in group B will be instructed about the effects of incentive spirometer to gain their cooperation during the study course.
Primary Outcome Measure Information:
Title
Assessing the change in lung functions
Description
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.
Time Frame
at baseline and after 6 weeks of intervention
Title
Assessing the change in symptoms of asthma
Description
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.
Time Frame
at baseline and after 6 weeks of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Outpatient clinic faculty of physical therapy cairo university
City
Dokki
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Incentive Spirometery on Asthmatic Pregnant Women
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