Efficacy of Acapella on Spirometry Measures in Patients W... | NCT05838144

Studies
Efficacy of Acapella on Spirometry Measures in Patients With Bronchiectasis

NCT05838144

Sponsor

South Valley University

Status

Unknown status

Last Update Posted

Jul 18, 2023Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Bronchiectasis

Interventions

Acapella device
Only routine chest physical therapy program

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2023Estimated

Primary Completion Date

Sep 30, 2023Estimated

Completion Date

Oct 20, 2023Estimated

First Submitted Date

Mar 24, 2023

First Submission Date that Met QC Criteria

Apr 20, 2023

First Posted Date

May 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2023

Last Update Posted Date

Jul 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acapella	Active Comparator	Will use Acapella device 3 times per day for 15 minutes for 7 days beside medications and routine physical therapy program.	Device: Acapella device Other: Only routine chest physical therapy program
Only routine physical therapy program	Placebo Comparator	Only they will receive medications and routine physical therapy program.	Other: Only routine chest physical therapy program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acapella device	Device	Group A. Will use Acapella device.	Acapella

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Spirometry measures	FVC, FEV1	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shymaa Y Abo zaid	Contact	01010941685	01091631018	shaymaayoussef397@gmail.com

Overall Officials

Name	Affiliation	Role
Shymaa Y Abo zaid	Lecturer	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shymaa yussuf abo zaid	Recruiting	Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D001987	Bronchiectasis

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided