Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000798268
Ethics application status
Approved
Date submitted
9/09/2009
Date registered
15/09/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improvement of Vital Capacity of healthy volunteers using Positive Reinforcement
Scientific title
Impact of positive reinforcement's use in the measurement of vital capacity in healthy volunteers: a Randomized Clinical
Trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impact of the use of positive reinforcement in the measurement of vital capacity in healthy volunteers 243701 0
Condition category
Condition code
Respiratory 239964 239964 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The vital capacity (VC) is related to gender, age, weight, posture, ethnicity and anthropometric features, and it can be changed by various diseases. To achieve this measurement is necessary patient’s motivation and understanding, clarity of the information provided and ability of the researcher. The aim of this study was to analyze the impact of positive reinforcement in the measurement of vital capacity in healthy volunteers. This is a randomized clinical trial conducted with 105 healthy volunteers, randomly allocated into two groups: control (G1) and intervention (G2). The VC was measured in both groups, but for the intervention group (G2) was added to positive reinforcement. The groups were examined for the baseline VC (VC1) and, after 15 days, were reassessed (VC2). For the positive reinforcement, it was used the following phrases: "Let's go ! Come on! ... Take a deep breath !", "Pull, pull, pull !"..., "Let go slowly ...", "Loose, loose, loose, loose everything!". Both phrases of encouragement and the measurements were performed by the same evaluator. The positive reinforcement was done only during the VC measurement, during about 1 minute.
Intervention code [1] 241239 0
Other interventions
Comparator / control treatment
The control group (G1) took the measure of VC without the positive reinforcement. As the intervention group (G2), G1 was examined for the baseline VC (VC1) and, after 15 days, were reassessed (VC2).
Control group
Active

Outcomes
Primary outcome [1] 240763 0
Vital capacity measurement (VC1). It was used a spirometer adapted to the expiratory one-way valve and a mask siliconized. As recommended by the American Thoracic Society, the measurement was repeated three times with one minute between repetitions, registering the highest value obtained.
Timepoint [1] 240763 0
At baseline
Secondary outcome [1] 257437 0
Vital capacity measurement (VC2). It was used a spirometer adapted to the expiratory one-way valve and a mask siliconized. As recommended by the American Thoracic Society, the measurement was repeated three times with one minute between repetitions, registering the highest value obtained.
Timepoint [1] 257437 0
At 15 days after intervention commencement

Eligibility
Key inclusion criteria
Healthy volunteers of both genders, who agreed to participate in the research.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Volunteers who showed postural changes that might compromise the mechanical ventilation, neuromuscular disorders, obstructive and restrictive diseases, smoking, hypertension, heart disease and body mass index (BMI) greater than 25 kg/m2.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
105
Accrual to date
Final
Recruitment outside Australia
Country [1] 2040 0
Brazil
State/province [1] 2040 0

Funding & Sponsors
Funding source category [1] 243613 0
Self funded/Unfunded
Name [1] 243613 0
Katia Avena
Country [1] 243613 0
Brazil
Primary sponsor type
Individual
Name
Katia Avena
Address
Florentino Silva Street, 162, Itaigara, 41.815-400, Salvador/BA
Country
Brazil
Secondary sponsor category [1] 237062 0
None
Name [1] 237062 0
Address [1] 237062 0
Country [1] 237062 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243740 0
University of Jorge Amado (UNIJORGE)
Ethics committee address [1] 243740 0
Ethics committee country [1] 243740 0
Brazil
Date submitted for ethics approval [1] 243740 0
Approval date [1] 243740 0
Ethics approval number [1] 243740 0

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

Contacts
Principal investigator
Name 30164 0
Address 30164 0
Country 30164 0
Phone 30164 0
Fax 30164 0
Email 30164 0
Contact person for public queries
Name 13411 0
Katia Avena
Address 13411 0
Florentino Silva Street, 162, Itaigara, 41.815-400, Salvador/BA
Country 13411 0
Brazil
Phone 13411 0
55 71 9609-6767
Fax 13411 0
Email 13411 0
[email protected]
Contact person for scientific queries
Name 4339 0
Katia Avena
Address 4339 0
Florentino Silva Street, 162, Itaigara, 41.815-400, Salvador/BA
Country 4339 0
Brazil
Phone 4339 0
55 71 9609-6767
Fax 4339 0
Email 4339 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.