Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01932684
Other study ID # Rhayssa dissertação
Secondary ID
Status Completed
Phase N/A
First received July 9, 2013
Last updated August 29, 2013
Start date June 2012
Est. completion date December 2012

Study information

Verified date December 2012
Source Universidade Federal de Pernambuco
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Breath-Stacking
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).
Incentive spirometry
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).
Device:
5000 Voldyne ® Sherwood Medical, USA

Silicone face mask


Locations

Country Name City State
Brazil Departamento de Fisioterapia-Universidade Federal de pernambuco Recife Pernambuco
Brazil Universidade Federal de Pernambuco Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The variation of the total volume and compartmental between technique Breath-Stacking in patients with Parkinson's disease 25 days Yes
Primary The variation of the total volume and compartmental in the technique incentive spirometry in patients with Parkinson's disease 25 days Yes
Secondary The duration of the effects of technical-Breath Stacking and incentive spirometry in patients with Parkinson's disease 25 days Yes