Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000669291
Ethics application status
Approved
Date submitted
5/08/2009
Date registered
6/08/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Relation Between Severity Of Asthma And The Handgrip As Indicator Of Global Force In Women
Scientific title
In patients with asthma, Is there any relation between handgrip - as an indicator of global force in women with asthma - and asthma severity?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 243455 0
Condition category
Condition code
Respiratory 239754 239754 0 0
Asthma
Musculoskeletal 239755 239755 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Handgrip strength assessed witn hydraulic dynamometer - the subject is driven to perform three manouvers of manual pressure in dynamometer and researcher registrate only the two higher values. The subject rest for one minute between the manouvers. The subject perform this test once a time.

Maximal inspiratory and expiratory pressure assessed with manovacuometry - the subject is driven to perform an maximal expiratory force in manovacuometer. This is performed to inspiratorry muscles too. The subject perform this teste thee times ande the researcher researcher registrate only the two higher values. The subject rest for one minute between the manouvers. The subject perform this test once a time.
Intervention code [1] 237070 0
Not applicable
Comparator / control treatment
No applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240518 0
Difference in handgrip strength between asthmatic and non-asthmatic women. This outcome was assessed with hydraulic dynamometer.
Timepoint [1] 240518 0
This is a cross-sectional study. The subject was assessed only one time.
Secondary outcome [1] 257072 0
Difference in handgrip strength in dominant and non-dominant hands for asthmatic women. This outcome was assessed with hydraulic dynamometer.
Timepoint [1] 257072 0
This is a cross-sectional study. The subject was assessed only one time.

Eligibility
Key inclusion criteria
Asthmatic women:
- disgnostic oh asthma
- more than twenty years
- being sedentary
- clinic stability
- musculoskeletical integrity
- Body mass index lower than 30kg/m2
- peripheral oxygen saturation (Spo2) higher than 88%
- no fever
- heard hate lower than 100 and higher than 60
- arterial pressure lower than 160/100 mmHg
Non asthmatic women:
- no respiratory disease
- normal espirometry
- the same criteria for inclusion of asthmatic women (except diagnostic of asthma)
Minimum age
20 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Asthmatic and Non-asthmatic:
- be smoker or alcoholic
- no other disease (only asthma for asmathic women)
- diseases that cause
upper limb strehngth deficit
- cognitive deficit
- neuromuscular disease
- absence of a limb

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 1933 0
Brazil
State/province [1] 1933 0
Distrito Ferderal

Funding & Sponsors
Funding source category [1] 237448 0
University
Name [1] 237448 0
Universidade Catolica de Brasilia
Country [1] 237448 0
Brazil
Primary sponsor type
Individual
Name
Renato Valduga
Address
SQN 104 Bloco E Apto 403 - Asa Norte - Brasilia - Distrito Federal - Brazil
Postcode: 70733-050
Country
Brazil
Secondary sponsor category [1] 236937 0
Individual
Name [1] 236937 0
Renata da Nobrega Souza de Castro
Address [1] 236937 0
Campus I- Q.S. 07 Lote 1 EPCT - Taguatinga - Distrito Feferal - Brazil
Postcode: 71.966-700
Country [1] 236937 0
Brazil
Other collaborator category [1] 808 0
Individual
Name [1] 808 0
Rosielen Batista Xavier
Address [1] 808 0
Campus I- Q.S. 07 Lote 1 EPCT - Taguatinga - Distrito Feferal - Brazil
Postcode: 71.966-700
Country [1] 808 0
Brazil
Other collaborator category [2] 809 0
Individual
Name [2] 809 0
Thais de Almeida Pessanha Guedes
Address [2] 809 0
Campus I- Q.S. 07 Lote 1 EPCT - Taguatinga - Distrito Feferal - Brazil
Postcode: 71.966-700
Country [2] 809 0
Brazil
Other collaborator category [3] 810 0
Individual
Name [3] 810 0
Otacilio Alves dos Reis
Address [3] 810 0
Campus I- Q.S. 07 Lote 1 EPCT - Taguatinga - Distrito Feferal - Brazil
Postcode: 71.966-700
Country [3] 810 0
Brazil
Other collaborator category [4] 811 0
Individual
Name [4] 811 0
Gustavo Azevedo Carvalho
Address [4] 811 0
Campus I- Q.S. 07 Lote 1 EPCT - Taguatinga - Distrito Feferal - Brazil
Postcode: 71.966-700
Country [4] 811 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239577 0
Comite de Etica em Pesquisa da Universidade Catolica de Brasilia
Ethics committee address [1] 239577 0
Ethics committee country [1] 239577 0
Brazil
Date submitted for ethics approval [1] 239577 0
30/07/2008
Approval date [1] 239577 0
18/08/2008
Ethics approval number [1] 239577 0
CEP/UCB no 96/2008

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

Contacts
Principal investigator
Name 30009 0
Address 30009 0
Country 30009 0
Phone 30009 0
Fax 30009 0
Email 30009 0
Contact person for public queries
Name 13256 0
Renato Valduga
Address 13256 0
SQN 104 bloco E Apto 403 - Asa Norte - Brasilia - Distrito Federal - Brazil
Postcode: 70733-050
Country 13256 0
Brazil
Phone 13256 0
+55 61 92776112
Fax 13256 0
Email 13256 0
[email protected]
Contact person for scientific queries
Name 4184 0
Renata da Nóbrega Souza de Castro
Address 4184 0
Quadra 201, lote 08, bloco C - Aguas Claras - Distrito Federal - Brazil
Postcode: 71937-540
Country 4184 0
Brazil
Phone 4184 0
+55 61 81147861
Fax 4184 0
Email 4184 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.