Back to resultsEfficacy of Acapella on Spirometry Measures in Patients With Bronchiectasis
Primary Purpose
Bronchiectasis
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Acapella device
Only routine chest physical therapy program
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiectasis
Eligibility Criteria
Inclusion Criteria: bronchiectasis patients. Age range between 40 to 55 years old of both gender. Cooperative patients. Exclusion Criteria: Patients with severe cardiac disorders. Un controlled hypertensive patients. Un controlled diabetic patients.
Sites / Locations
- Shymaa yussuf abo zaidRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Acapella
Only routine physical therapy program
Arm Description
Will use Acapella device 3 times per day for 15 minutes for 7 days beside medications and routine physical therapy program.
Only they will receive medications and routine physical therapy program.
Outcomes
Primary Outcome Measures
Spirometry measures
FVC, FEV1
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05838144
Brief Title
Efficacy of Acapella on Spirometry Measures in Patients With Bronchiectasis
Official Title
Efficacy of Acapella on Spirometry Measures in Patients With Bronchiectasis.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley 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
Acapella group. Will use Acapella device for 3 times per day for 15 minutes for 7 days beside medications and routine chest physical therapy program .
Only routine physical therapy program group ( control group). Will only take medications and routine chest physical therapy program.
Detailed Description
Acapella group.Will use Acapella device for 3 times per day for 15 minutes for 7 days beside medications and routine chest physical therapy program.
Only routine physical therapy program group( control group). Will only take medications and routine chest physical therapy program Spirometer measures such as forced vital capacity (FVC) and forced expiratory volume in the first second (FEV1) will be measured for every patient before and after the end of 7 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acapella
Arm Type
Active Comparator
Arm Description
Will use Acapella device 3 times per day for 15 minutes for 7 days beside medications and routine physical therapy program.
Arm Title
Only routine physical therapy program
Arm Type
Placebo Comparator
Arm Description
Only they will receive medications and routine physical therapy program.
Intervention Type
Device
Intervention Name(s)
Acapella device
Intervention Description
Group A. Will use Acapella device.
Intervention Type
Other
Intervention Name(s)
Only routine chest physical therapy program
Intervention Description
Group B. Will take medications and perform routine chest physical therapy program.
Primary Outcome Measure Information:
Title
Spirometry measures
Description
FVC, FEV1
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
bronchiectasis patients.
Age range between 40 to 55 years old of both gender.
Cooperative patients.
Exclusion Criteria:
Patients with severe cardiac disorders.
Un controlled hypertensive patients.
Un controlled diabetic patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shymaa Y Abo zaid
Phone
01010941685
Ext
01091631018
Email
shaymaayoussef397@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shymaa Y Abo zaid
Organizational Affiliation
Lecturer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shymaa yussuf abo zaid
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shymaa Y Abo zaid
Phone
01010941685
Ext
01091631018
Email
shaymaayoussef397@gmail.com
First Name & Middle Initial & Last Name & Degree
Shymaa Y Abo zaid, Doctoral
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Acapella on Spirometry Measures in Patients With Bronchiectasis
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