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Effects Of Breath And Stacking-Spirometry Incentive in Patients With Parkinson's Disease

Primary Purpose

Parkinson's Disease.

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Breath-Stacking
Incentive spirometry
5000 Voldyne ® Sherwood Medical, USA
Silicone face mask
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease.

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal de Pernambuco
  • Departamento de Fisioterapia-Universidade Federal de pernambuco

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Incentive spirometry

Control Group

Breath Stacking

Arm Description

Was utilized an incentive spirometer volume in this group.

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.

Outcomes

Primary Outcome Measures

The variation of the total volume and compartmental between technique Breath-Stacking in patients with Parkinson's disease
The variation of the total volume and compartmental in the technique incentive spirometry in patients with Parkinson's disease

Secondary Outcome Measures

The duration of the effects of technical-Breath Stacking and incentive spirometry in patients with Parkinson's disease

Full Information

First Posted
July 9, 2013
Last Updated
August 29, 2013
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT01932684
Brief Title
Effects Of Breath And Stacking-Spirometry Incentive in Patients With Parkinson's Disease
Official Title
EFFECTS OF BREATH AND STACKING-SPIROMETRY INCENTIVE PACKAGES IN THE RIB CAGE IN PATIENTS WITH PARKINSON'S DISEASE
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Incentive spirometry
Arm Type
Experimental
Arm Description
Was utilized an incentive spirometer volume in this group.
Arm Title
Control Group
Arm Type
No Intervention
Arm Title
Breath Stacking
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Breath-Stacking
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Incentive spirometry
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
5000 Voldyne ® Sherwood Medical, USA
Intervention Type
Device
Intervention Name(s)
Silicone face mask
Primary Outcome Measure Information:
Title
The variation of the total volume and compartmental between technique Breath-Stacking in patients with Parkinson's disease
Time Frame
25 days
Title
The variation of the total volume and compartmental in the technique incentive spirometry in patients with Parkinson's disease
Time Frame
25 days
Secondary Outcome Measure Information:
Title
The duration of the effects of technical-Breath Stacking and incentive spirometry in patients with Parkinson's disease
Time Frame
25 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RHAYSSA RH RIBEIRO, Msc
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Pernambuco
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50670-901
Country
Brazil
Facility Name
Departamento de Fisioterapia-Universidade Federal de pernambuco
City
Recife
State/Province
Pernambuco
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
2301851
Citation
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.
Results Reference
result
PubMed Identifier
9018522
Citation
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.
Results Reference
result
PubMed Identifier
12548348
Citation
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.
Results Reference
result

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Effects Of Breath And Stacking-Spirometry Incentive in Patients With Parkinson's Disease

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