Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000773235
Ethics application status
Approved
Date submitted
20/08/2009
Date registered
7/09/2009
Date last updated
7/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Respiratory muscle strength, body posture, vocal intensity and maximum phonation times in Parkinson´s disease
Scientific title
Respiratory muscle strength, body posture, vocal intensity and maximum phonation times in Parkinson´s disease
Universal Trial Number (UTN)
Trial acronym
RPVOPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson?s Disease 237362 0
Condition category
Condition code
Neurological 239683 239683 0 0
Parkinson's disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Check the findings of respiratory muscular strength (RMS), body posture (BP), vocal intensity (VI) and maximum phonation time (MPT), in patients with Parkinson´s Disease (PD) and control cases, in according to sex, Parkinson Disease stage (PD) and the level of physical activity (PA).
All these factors were assessed on one single day
Intervention code [1] 237017 0
Not applicable
Comparator / control treatment
Three men and two women with PD, between 36 and 63 years old (study cases – SC), and five individuals without neurologic diseases, of the same age, sex and PA level (control cases – CC); RMS, BP, VI and MPT.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240456 0
Maximum phonation time (MPT) was measured by digital stopwatch.
Timepoint [1] 240456 0
All samples were collected three times each on assessment. It was chosen the most valuable.
Primary outcome [2] 240747 0
Respiratory muscle strength was measured using the digital manometer.
Timepoint [2] 240747 0
Each airway pressure was measured three to five times on assessment, being selected the most value.
Secondary outcome [1] 244990 0
Assessment of body posture was performed by a physical therapist collaboratively research.
Timepoint [1] 244990 0
This assessment was made on the assessment
Secondary outcome [2] 257397 0
Vocal intensity was performed using a digital decibel.
Timepoint [2] 257397 0
This assessment was executed once

Eligibility
Key inclusion criteria
Neurological diagnosis of Parkinson's disease (PD), female and male, between 35 and 65 years, speakers of Brazilian Portuguese (BP)
Minimum age
35 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive deficits, abnormalities in laryngological assessment, not the changes typical of PD and laryngeal or aging; spirometric signs or symptoms of chronic obstructive pulmonary disease; be performing speech processing and / or physical therapy; be professional voice, be smoked and / or consume alcohol in excess, hearing loss, singing in choirs.

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
15/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 1919 0
Brazil
State/province [1] 1919 0

Funding & Sponsors
Funding source category [1] 237400 0
Self funded/Unfunded
Name [1] 237400 0
Fernanda Vargas Ferreira
Country [1] 237400 0
Brazil
Funding source category [2] 243604 0
Self funded/Unfunded
Name [2] 243604 0
Country [2] 243604 0
Brazil
Primary sponsor type
Individual
Name
Fernanda Vargas Ferreira
Address
Rua Visconde de Pelotas 517
Country
Brazil
Secondary sponsor category [1] 236897 0
None
Name [1] 236897 0
Address [1] 236897 0
Country [1] 236897 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239532 0
Comite de Etica em Pesquisa Universidade Federal de Santa Maria
Ethics committee address [1] 239532 0
Ethics committee country [1] 239532 0
Brazil
Date submitted for ethics approval [1] 239532 0
06/06/2007
Approval date [1] 239532 0
06/07/2007
Ethics approval number [1] 239532 0
23081. 008439/2007-16

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

Contacts
Principal investigator
Name 29967 0
Address 29967 0
Country 29967 0
Phone 29967 0
Fax 29967 0
Email 29967 0
Contact person for public queries
Name 13214 0
Fernanda Vargas Ferreira
Address 13214 0
Rua Visconde de Pelotas 517
Country 13214 0
Brazil
Phone 13214 0
55 3225-2435
Fax 13214 0
Email 13214 0
[email protected]
Contact person for scientific queries
Name 4142 0
Fernanda Vargas Ferreira
Address 4142 0
Rua Visconde de Pelotas 517
Country 4142 0
Brazil
Phone 4142 0
55 3225-2435
Fax 4142 0
Email 4142 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.