Parkinson's Disease.NCT01932684
Effects Of Breath And Stacking-Spirometry Incentive in Patients With Parkinson's Disease
A study testing Breath-Stacking, Incentive spirometry and 5000 Voldyne ® Sherwood Medical, USA in people with Parkinson's Disease., run by Universidade Federal de Pernambuco at 2 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson's Disease.
- What is being tested?
- Breath-Stacking, Incentive spirometry and 5000 Voldyne ® Sherwood Medical, USA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesBrazil
- Study dates
- Jun 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Regular pharmacological treatment with levodopa and / or medications antiparkinsonian.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Universidade Federal de Pernambuco
Recife, Pernambuco, 50670-901
Departamento de Fisioterapia-Universidade Federal de pernambuco
Recife, Pernambuco
About this study
Official title: 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.
- Conditions
- Parkinson's Disease.
- Being tested
- Breath-Stacking, Incentive spirometry, 5000 Voldyne ® Sherwood Medical, USA, Silicone face mask
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath-StackingOther
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 spirometryOther
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).
5000 Voldyne ® Sherwood Medical, USADevice
Silicone face maskDevice
| Study group | Role | What they receive |
|---|---|---|
| Incentive spirometry | Experimental | Was utilized an incentive spirometer volume in this group. Receives: Other: Incentive spirometry; Device: 5000 Voldyne ® Sherwood Medical, USA |
| Control Group | No intervention | Not described |
| 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. Receives: Other: Breath-Stacking; Device: Silicone face mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
The variation of the total volume and compartmental between technique Breath-Stacking in patients with Parkinson's disease
Measured: 25 days
The variation of the total volume and compartmental in the technique incentive spirometry in patients with Parkinson's disease
Measured: 25 days
Secondary outcomes (1)
The duration of the effects of technical-Breath Stacking and incentive spirometry in patients with Parkinson's disease
Measured: 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniella Cunha Brandao, Universidade Federal de Pernambuco
- Investigators
- RHAYSSA RH RIBEIRO, Msc, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932684
- Sponsor's protocol ID
- Rhayssa dissertação
- Status last verified
- Dec 2012
- First submitted
- 9 Jul 2013
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 2301851Cala 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.
PubMed 9018522De 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.
PubMed 12548348
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF BREATH AND STACKING-SPIROMETRY INCENTIVE PACKAGES IN THE RIB CAGE IN PATIENTS WITH PARKINSON'S DISEASE
- ClinicalTrials.gov ID
- NCT01932684
- Acronym / sponsor ID
- Rhayssa dissertação
- Conditions
- Parkinson's Disease.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Incentive spirometry | Experimental | Other: Incentive spirometry, Device: 5000 Voldyne ® Sherwood Medical, USAWas utilized an incentive spirometer volume in this group. |
| Control Group | No intervention | – |
| Breath Stacking | Experimental | Other: Breath-Stacking, Device: Silicone face maskWe 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Regular pharmacological treatment with levodopa and / or medications antiparkinsonian.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath-StackingWe 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). | Other | Breath Stacking |
| Incentive spirometryWe 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). | Other | Incentive spirometry |
| 5000 Voldyne ® Sherwood Medical, USA | Device | Incentive spirometry |
| Silicone face mask | Device | Breath Stacking |
Primary outcome
The variation of the total volume and compartmental between technique Breath-Stacking in patients with Parkinson's disease
Time frame: 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
1 secondary outcome
The duration of the effects of technical-Breath Stacking and incentive spirometry in patients with Parkinson's disease
Time frame: 25 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
- Results publication: PubMed 2301851Baker 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 publication: PubMed 9018522Cala 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 publication: PubMed 12548348De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RHAYSSA RH RIBEIRO, Msc principal investigator
Universidade Federal do Rio Grande do Norte
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath-Stacking, Incentive spirometry and 5000 Voldyne ® Sherwood Medical, USA in people with Parkinson's Disease., run by Universidade Federal de Pernambuco at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The variation of the total volume and compartmental between technique Breath-Stacking in patients with Parkinson's disease (time frame: 25 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01932684, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2013.