Efficacy of Acapella on Spirometry Measures in Patients With Bronchiectasis

July 15, 2023 updated by: Shymaa yussuf abo zaid, South Valley University

Efficacy of Acapella on Spirometry Measures in Patients With Bronchiectasis.

  1. 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 .
  2. Only routine physical therapy program group ( control group). Will only take medications and routine chest physical therapy program.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. 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.
  2. 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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Shymaa yussuf abo zaid
        • Contact:
        • Principal Investigator:
          • Shymaa Y Abo zaid, Doctoral

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. bronchiectasis patients.
  2. Age range between 40 to 55 years old of both gender.
  3. Cooperative patients.

Exclusion Criteria:

  1. Patients with severe cardiac disorders.
  2. Un controlled hypertensive patients.
  3. Un controlled diabetic patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acapella
Will use Acapella device 3 times per day for 15 minutes for 7 days beside medications and routine physical therapy program.
Device: Acapella device
Group A. Will use Acapella device.
Other: Only routine chest physical therapy program
Group B. Will take medications and perform routine chest physical therapy program.
Placebo Comparator: Only routine physical therapy program
Only they will receive medications and routine physical therapy program.
Other: Only routine chest physical therapy program
Group B. Will take medications and perform routine chest physical therapy program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spirometry measures
Time Frame: 7 days
FVC, FEV1
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Investigators

  • Principal Investigator: Shymaa Y Abo zaid, Lecturer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

September 30, 2023

Study Completion (Estimated)

October 20, 2023

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 15, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT-IMG-02/2023-505

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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