NCT01932684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
Last Updated

August 30, 2013

Status Verified

December 1, 2012

Enrollment Period

Same day

First QC Date

July 9, 2013

Last Update Submit

August 29, 2013

Conditions

Outcome Measures

Primary Outcomes (2)

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

    25 days

  • The variation of the total volume and compartmental in the technique incentive spirometry in patients with Parkinson's disease

    25 days

Secondary Outcomes (1)

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

    25 days

Study Arms (3)

Incentive spirometry

EXPERIMENTAL

Was utilized an incentive spirometer volume in this group.

Other: Incentive spirometryDevice: 5000 Voldyne ® Sherwood Medical, USA

Control Group

NO INTERVENTION

Breath Stacking

EXPERIMENTAL

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.

Other: Breath-StackingDevice: Silicone face mask

Interventions

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).

Breath Stacking

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).

Incentive spirometry
Incentive spirometry
Breath Stacking

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Regular pharmacological treatment with levodopa and / or medications antiparkinsonian.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidade Federal de Pernambuco

Recife, Pernambuco, 50670-901, Brazil

Location

Departamento de Fisioterapia-Universidade Federal de pernambuco

Recife, Pernambuco, Brazil

Location

Related 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. doi: 10.1164/ajrccm/141.2.343.

  • 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.

  • 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.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • RHAYSSA RH RIBEIRO, Msc

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 9, 2013

First Posted

August 30, 2013

Study Start

June 1, 2012

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

August 30, 2013

Record last verified: 2012-12

Locations