- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01932684
Effects Of Breath And Stacking-Spirometry Incentive in Patients With Parkinson's Disease
August 29, 2013 updated by: Daniella Cunha Brandao, Universidade Federal de Pernambuco
EFFECTS OF BREATH AND STACKING-SPIROMETRY INCENTIVE PACKAGES IN THE RIB CAGE IN PATIENTS WITH PARKINSON'S DISEASE
Objective: To evaluate the effects of technical-Breath Stacking (BS) and incentive spirometry (IS) on the volume of the chest immediately after and within thirty minutes after the techniques in patients with Parkinson's disease (PD).
Methods: This is a study of cross-over.
The study investigated 14 patients with mild to moderate PD.
The subjects performed the technique Breath-Stacking, incentive spirometry volume and participated in a phase control according to randomization.
The volunteers were evaluated by opto-electronic plethysmography in four stages: before, immediately after fifteen and thirty minutes after the completion of the techniques.
The investigators used a repeated measures ANOVA with post-hoc Tukey test for parametric variables, and the Friedman test with post-hoc Dunns for nonparametric variables.
The level of significance was set at 5%, p <0.05.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pernambuco
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Recife, Pernambuco, Brazil, 50670-901
- Universidade Federal de Pernambuco
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Recife, Pernambuco, Brazil
- Departamento de Fisioterapia-Universidade Federal de pernambuco
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Regular pharmacological treatment with levodopa and / or medications antiparkinsonian.
Exclusion Criteria:
- Patients who had previous lung disease;
- Altered mental status indicated by the MMSE (Mini Mental State Examination;
- A change in medication during the study;
- Demonstrated inability to perform satisfactorily any of the collection procedures of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control Group
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EXPERIMENTAL: Incentive spirometry
Was utilized an incentive spirometer volume in this group.
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We used an incentive spirometer volume (5000 Voldyne ® Sherwood Medical, USA).
Subjects performed slow, deep inhalations from functional residual capacity to total lung capacity, seeking to sustain the inspiration for at least three seconds (Restrepo et al., 2011).
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EXPERIMENTAL: Breath Stacking
We used a face mask silicone connected to a check valve allowing only inspiration and is connected to a spirometer showed that the volume inspired by the individual.
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We used a silicone face mask, connected to a unidirectional valve which allowed only inspiration and is connected to a spirometer showed that the volume inspired by the individual.
The face mask was attached to the appraised performed successive breaths until the researcher realized the lack of volume of air being inhaled and this time it was allowed to expire (Baker et al., 1990; Feitosa et al., 2012).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The variation of the total volume and compartmental between technique Breath-Stacking in patients with Parkinson's disease
Time Frame: 25 days
|
25 days
|
The variation of the total volume and compartmental in the technique incentive spirometry in patients with Parkinson's disease
Time Frame: 25 days
|
25 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The duration of the effects of technical-Breath Stacking and incentive spirometry in patients with Parkinson's disease
Time Frame: 25 days
|
25 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: RHAYSSA RH RIBEIRO, Msc, Universidade Federal do Rio Grande do Norte
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cala SJ, Kenyon CM, Ferrigno G, Carnevali P, Aliverti A, Pedotti A, Macklem PT, Rochester DF. Chest wall and lung volume estimation by optical reflectance motion analysis. J Appl Physiol (1985). 1996 Dec;81(6):2680-9. doi: 10.1152/jappl.1996.81.6.2680.
- Baker WL, Lamb VJ, Marini JJ. Breath-stacking increases the depth and duration of chest expansion by incentive spirometry. Am Rev Respir Dis. 1990 Feb;141(2):343-6. doi: 10.1164/ajrccm/141.2.343.
- De Pandis MF, Starace A, Stefanelli F, Marruzzo P, Meoli I, De Simone G, Prati R, Stocchi F. Modification of respiratory function parameters in patients with severe Parkinson's disease. Neurol Sci. 2002 Sep;23 Suppl 2:S69-70. doi: 10.1007/s100720200074.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (ACTUAL)
June 1, 2012
Study Completion (ACTUAL)
December 1, 2012
Study Registration Dates
First Submitted
July 9, 2013
First Submitted That Met QC Criteria
August 29, 2013
First Posted (ESTIMATE)
August 30, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
August 30, 2013
Last Update Submitted That Met QC Criteria
August 29, 2013
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rhayssa dissertação
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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