Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000939099
Ethics application status
Approved
Date submitted
28/10/2010
Date registered
4/11/2010
Date last updated
4/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physiotherapy in bronchiectasis after removal of foreign body: case report
Scientific title
Report of a man of 68 years, with bronchiectasis underwent physiotherapy after removal of foreign body by bronchoscopy, achieving satisfactory results as bronchial hygiene, atelectasis reexpansion of areas, improving lung function and increased physical strength after the intervention.
Secondary ID [1] 252982 0
3508/2010 Ethics Committee of the Faculdade de Medicina de Rio Preto FAMERP
Universal Trial Number (UTN)
U1111-1117-6200
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 258522 0
Condition category
Condition code
Respiratory 258667 258667 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Underwent 20 sessions lasting 45 minutes, 05 days per week, with the techniques applied on the same day: postural drainage associated with inhalation therapy (15 minutes), chest percussion (05 minutes), vibro during exhalation associated with maneuver negative pressure during inspiration (05 minutes), an incentive spirometer (03 sets of 08 repetitions with 01-minute intervals), raising exercise inspiratory flow (03 sets of 02 minutes and 01 minutes of rest between sets); in sitting position oscillating positive pressure (03 minutes), positive expiratory pressure mask airway (10 minutes), manual assisted cough (05 reps with 30 second intervals); After 20 sessions the patient was included in a Pulmonary Rehabilitation program for more than 20 sessions 45 minutes, 05 times per week, consisting of expiration and inspiration in times short (03 sets of 08 repetitions with 01 minutes intervals), heating and conditioning on a treadmill (20 minutes), diaphragmatic breathing (03 sets of 08 repetitions with 01 minute interval).
Intervention code [1] 257520 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259522 0
reexpansion of the area atelectasis and improves the function of the left lung measured by computed tomography.
Timepoint [1] 259522 0
after 40 session
Primary outcome [2] 259532 0
Increased physical strength when measured by the Walk Test in Six Minutes.
Timepoint [2] 259532 0
after 40 session
Primary outcome [3] 259533 0
Improved quality of life by Short Form Health Survey Questionnaire in functional capacity, vitality, mental health, social aspects, reduction of the physical limitations and emotional problems.
Timepoint [3] 259533 0
after 40 session
Secondary outcome [1] 266132 0
improving lung function by peak flow, and the manometer.
Timepoint [1] 266132 0
after 40 session
Secondary outcome [2] 266148 0
improvement of physical strength by the six-minute walk test.
Timepoint [2] 266148 0
after 40 session
Secondary outcome [3] 266149 0
bronchial hygiene by auscultation lung.
Timepoint [3] 266149 0
after 40 session

Eligibility
Key inclusion criteria
Carrier bronchiectasis after removal of foreign body
Minimum age
68 Years
Maximum age
68 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Carrier bronchiectasis home without foreign body

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study with commitment and clear to the patient, with liberty to quit the study at the time thought necessary.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1
Accrual to date
Final
Recruitment outside Australia
Country [1] 3003 0
Brazil
State/province [1] 3003 0
Sao paulo

Funding & Sponsors
Funding source category [1] 257944 0
University
Name [1] 257944 0
Centro Universitario de Rio Preto
Country [1] 257944 0
Brazil
Primary sponsor type
Individual
Name
Joao Simao de Melo Neto
Address
Street Joaquim Manoel Pires, 333, ap. 11, Sao Manoel, Sao Jose do Rio Preto, Sao Paulo, CEP 15091-210
Country
Brazil
Secondary sponsor category [1] 257152 0
Individual
Name [1] 257152 0
Sueli Aparecida Alves
Address [1] 257152 0
Avenue Clovis oger, 666, Distrito Industrial, Sao Jose do Rio Preto, Sao Paulo, CEP 15035-580
Country [1] 257152 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259953 0
ethics committee on research of Faculdade de Medicina de Rio Preto
Ethics committee address [1] 259953 0
Ethics committee country [1] 259953 0
Brazil
Date submitted for ethics approval [1] 259953 0
26/05/2010
Approval date [1] 259953 0
14/06/2010
Ethics approval number [1] 259953 0
3508/2010

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31842 0
Address 31842 0
Country 31842 0
Phone 31842 0
Fax 31842 0
Email 31842 0
Contact person for public queries
Name 15089 0
Joao Simao de Melo Neto
Address 15089 0
street Joaquim Manoel Pires,111 - Sao Manoel, Sao Jose do Rio Preto, Sao Paulo, CEP 15091-210
Country 15089 0
Brazil
Phone 15089 0
+55 17 96174258
Fax 15089 0
+55 17 32116060
Email 15089 0
[email protected]
Contact person for scientific queries
Name 6017 0
Joao Simao de Melo Neto
Address 6017 0
street Joaquim Manoel Pires,111 - Sao Manoel, Sao Jose do Rio Preto, Sao Paulo, CEP 15091-210
Country 6017 0
Brazil
Phone 6017 0
+55 17 96174258
Fax 6017 0
+55 17 32116060
Email 6017 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.