NCT05838144

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

March 24, 2023

Last Update Submit

July 15, 2023

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (1)

  • Spirometry measures

    FVC, FEV1

    7 days

Study Arms (2)

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 deviceOther: 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

Acapella deviceDEVICE

Group A. Will use Acapella device.

Acapella
Only routine chest physical therapy programOTHER

Group B. Will take medications and perform routine chest physical therapy program.

AcapellaOnly routine physical therapy program

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • bronchiectasis patients.
  • Age range between 40 to 55 years old of both gender.
  • Cooperative patients.

You may not qualify if:

  • Patients with severe cardiac disorders.
  • Un controlled hypertensive patients.
  • Un controlled diabetic patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shymaa yussuf abo zaid

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Officials

  • Shymaa Y Abo zaid

    Lecturer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shymaa Y Abo zaid

CONTACT

01010941685shaymaayoussef397@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 24, 2023

First Posted

May 1, 2023

Study Start

August 1, 2023

Primary Completion

September 30, 2023

Study Completion

October 20, 2023

Last Updated

July 18, 2023

Record last verified: 2023-07

Locations

EG(1)