Parkinson DiseaseNCT02600052
Efficacy of Pattern Respiratory PNF Associated Aerobic Training on Lung Volumes and 6MWT Test in Parkinson Individuals
A study testing PNF and treadmill in people with Parkinson Disease, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
INTRODUCTION: Parkinson's disease (PD) is a neurodegenerative disorder that causes motor disorders such as bradykinesia, rigidity and tremor. In addition to the motor symptoms occurring in the overall PD patients, mostly there is associated respiratory disorders. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- PNF and treadmill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- May 2016to Apr 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals with stage II and III between the Hoehn and Yahr classification;
- minimum score of 28 on the Mini Mental Examination for Parkinson.
Who cannot join
- individuals with rheumatologic or orthopedic diseases or deformities / abnormalities in the spine that compromise the respiratory mechanics;
- respiratory comorbidities;
- history of smoking;
- history of thoracic or abdominal surgery;
- clinical instability characterized by infections and / or hemodynamic defined as greater than 150 bpm heart rate or systolic blood pressure less than 90 mmHg;
- Not present exchange of the drug in the last 30 days.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Pernambuco
Recife, Pernambuco, 50740560
Carlos Rego Barros, +55 81 21268496, carlosregobarros@hotmail.com
Armele Dornelas, +55 81 21268496, armeledornelas@yahoo.com
About this study
Official title: Efficacy of Pattern Respiratory Proprioceptive Neuromuscular Facilitation Associated With Aerobic Training on the Volumes, Lung Capacity and Six-minute Walking Test in Individuals With Parkinson: Randomized Clinical Trial
INTRODUCTION:
Parkinson's disease (PD) is a neurodegenerative disorder that causes motor disorders such as bradykinesia, rigidity and tremor. In addition to the motor symptoms occurring in the overall PD patients, mostly there is associated respiratory disorders. The respiratory impairment may be due by postural changes, limiting the flexibility and expandability of the chest wall causing decreased lung volumes and flows. So the exercise Proprioceptive Neuromuscular Facilitation (PNF) is a tool designed to reduce the changes in respiratory function, the commitment of the respiratory muscles, and allows greater flexibility of the chest wall, reducing the rigidity of the rib cage. To evaluate the effects of respiratory pattern of Proprioceptive Neuromuscular Facilitation on the distribution of pulmonary ventilation, compartmental volumes of diaphragmatic mobility and functional capacity in patients with Parkinson's disease.
Read more
METHODS:
The study is a clinical trial randomized, in which participants to be elected for the study should present diagnosis of PD, staging of disease between II and III according to Hoehn and Yahr. Initially, the participants will undergo the collection of data on medical history, assessment of pulmonary function by spirometry and respiratory muscle strength measured by the manometer. Then will undergo evaluation of the breathing pattern and tricompartmental distribution of the volume of the chest wall by hemithorax by Plethysmography Optoelectronic; Quantify the mobility of the right diaphragm in total lung capacity for maneuver and during the current volume by ultrasonography. After the evaluation, participants will undergo intervention which will consist of three stages: first occur first session of the PNF later aerobic training for 30 minutes, ending with one PNF session.
- Conditions
- Parkinson Disease
- Being tested
- PNF, treadmill
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNFOther
RESPIRATORY PATTERN PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION
treadmillDevice
AEROBIC TRAINING
| Study group | Role | What they receive |
|---|---|---|
| GPNF | Experimental | Patients will be submitted to aerobic training, with prior application of PNF technique and after its completion. Aerobic training program will consist of walking on a treadmill for 30 minutes with 5 minute initial heating and 5-minute cool-down. The training intensity will correspond to 60% of maximal oxygen consumption (VO2max) or 70% of maximum heart rate (MHR) predicted by age is determined by the formula: HR max = 208 - (0.7 x age). The speed and incline of the treadmill will be adjusted according to the patient's performance, so that they maintain the same intensity throughout the course of the training. Receives: Other: PNF; Device: treadmill |
| GCONTROL | Active comparator | Patients will be submitted to aerobic training, with prior application of relax technique and after its completion. Aerobic training program will consist of walking on a treadmill for 30 minutes with 5 minute initial heating and 5-minute cool-down. The training intensity will correspond to 60% of maximal oxygen consumption (VO2max) or 70% of maximum heart rate (MHR) predicted by age is determined by the formula: HR max = 208 - (0.7 x age). The speed and incline of the treadmill will be adjusted according to the patient's performance, so that they maintain the same intensity throughout the course of the training. Receives: Device: treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
LUNG VOLUME
BY OPTOELECTRONIC PLETHYSMOGRAPHY
Measured: 1 MONTH
WALKING DISTANCE, VO2, VCO2
SIX-MINUTE WALK TEST PLUS CÓRTEX
Measured: 1 MONTH
Secondary outcomes (2)
DIAPHRAGM MOBILITY
ULTRASOUND
Measured: 1 MONTH
DIAPHRAGM THICKNESS
ULTRASOUND
Measured: 1 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startMay 2016
- Primary completionDec 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Rego Barros, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600052
- Sponsor's protocol ID
- 06704028420
- Status last verified
- Jan 2016
- First submitted
- 3 Nov 2015
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Costa A, Bagoj E, Monaco M, Zabberoni S, De Rosa S, Mundi C, Caltagirone C, Carlesimo GA. Mini mental Parkinson test: standardization and normative data on an Italian sample. Neurol Sci. 2013 Oct;34(10):1797-803. doi: 10.1007/s10072-013-1342-8. Epub 2013 Mar 12.
PubMed 23479031Isella V, Mapelli C, Morielli N, De Gaspari D, Siri C, Pezzoli G, Antonini A, Poletti M, Bonuccelli U, Picchi L, Napolitano A, Vista M, Greco A, Appollonio IM. Validity and metric of MiniMental Parkinson and MiniMental State Examination in Parkinson's disease. Neurol Sci. 2013 Oct;34(10):1751-8. doi: 10.1007/s10072-013-1328-6. Epub 2013 Feb 20.
PubMed 23423464Carvalho A, Barbirato D, Araujo N, Martins JV, Cavalcanti JL, Santos TM, Coutinho ES, Laks J, Deslandes AC. Comparison of strength training, aerobic training, and additional physical therapy as supplementary treatments for Parkinson's disease: pilot study. Clin Interv Aging. 2015 Jan 7;10:183-91. doi: 10.2147/CIA.S68779. eCollection 2015.
PubMed 25609935Pereira CA, Sato T, Rodrigues SC. New reference values for forced spirometry in white adults in Brazil. J Bras Pneumol. 2007 Jul-Aug;33(4):397-406. doi: 10.1590/s1806-37132007000400008. English, Portuguese.
PubMed 17982531Aliverti A, Pedotti A. Opto-electronic plethysmography. Monaldi Arch Chest Dis. 2003 Jan-Mar;59(1):12-6.
PubMed 14533277Testa A, Soldati G, Giannuzzi R, Berardi S, Portale G, Gentiloni Silveri N. Ultrasound M-mode assessment of diaphragmatic kinetics by anterior transverse scanning in healthy subjects. Ultrasound Med Biol. 2011 Jan;37(1):44-52. doi: 10.1016/j.ultrasmedbio.2010.10.004.
PubMed 21144957Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. doi: 10.1590/s0100-879x1999000600007.
PubMed 10412550Erratum: "Spirometry: step by step". V.C. Moore. Breathe 2012; 8: 232-240. Breathe (Sheff). 2022 Sep;18(3):115217. doi: 10.1183/20734735.5217-2011. Epub 2022 Nov 15.
PubMed 36867111Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. General considerations for lung function testing. Eur Respir J. 2005 Jul;26(1):153-61. doi: 10.1183/09031936.05.00034505. No abstract available.
PubMed 15994402
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pattern Respiratory Proprioceptive Neuromuscular Facilitation Associated With Aerobic Training on the Volumes, Lung Capacity and Six-minute Walking Test in Individuals With Parkinson: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02600052
- Acronym / sponsor ID
- 06704028420
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 9 Nov 2015 (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.
INTRODUCTION:
Parkinson's disease (PD) is a neurodegenerative disorder that causes motor disorders such as bradykinesia, rigidity and tremor. In addition to the motor symptoms occurring in the overall PD patients, mostly there is associated respiratory disorders. The respiratory impairment may be due by postural changes, limiting the flexibility and expandability of the chest wall causing decreased lung volumes and flows. So the exercise Proprioceptive Neuromuscular Facilitation (PNF) is a tool designed to reduce the changes in respiratory function, the commitment of the respiratory muscles, and allows greater flexibility of the chest wall, reducing the rigidity of the rib cage. To evaluate the effects of respiratory pattern of Proprioceptive Neuromuscular Facilitation on the distribution of pulmonary ventilation, compartmental volumes of diaphragmatic mobility and functional capacity in patients with Parkinson's disease.
METHODS:
The study is a clinical trial randomized, in which participants to be elected for the study should present diagnosis of PD, staging of disease between II and III according to Hoehn and Yahr. Initially, the participants will undergo the collection of data on medical history, assessment of pulmonary function by spirometry and respiratory muscle strength measured by the manometer. Then will undergo evaluation of the breathing pattern and tricompartmental distribution of the volume of the chest wall by hemithorax by Plethysmography Optoelectronic; Quantify the mobility of the right diaphragm in total lung capacity for maneuver and during the current volume by ultrasonography. After the evaluation, participants will undergo intervention which will consist of three stages: first occur first session of the PNF later aerobic training for 30 minutes, ending with one PNF session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GPNF | Experimental | Other: PNF, Device: treadmillPatients will be submitted to aerobic training, with prior application of PNF technique and after its completion. Aerobic training program will consist of walking on a treadmill for 30 minutes with 5 minute initial heating and 5-minute cool-down. The training intensity will correspond to 60% of maximal oxygen consumption (VO2max) or 70% of maximum heart rate (MHR) predicted by age is determined by the formula: HR max = 208 - (0.7 x age). The speed and incline of the treadmill will be adjusted according to the patient's performance, so that they maintain the same intensity throughout the course of the training. |
| GCONTROL | Active comparator | Device: treadmillPatients will be submitted to aerobic training, with prior application of relax technique and after its completion. Aerobic training program will consist of walking on a treadmill for 30 minutes with 5 minute initial heating and 5-minute cool-down. The training intensity will correspond to 60% of maximal oxygen consumption (VO2max) or 70% of maximum heart rate (MHR) predicted by age is determined by the formula: HR max = 208 - (0.7 x age). The speed and incline of the treadmill will be adjusted according to the patient's performance, so that they maintain the same intensity throughout the course of the training. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals with stage II and III between the Hoehn and Yahr classification;
- minimum score of 28 on the Mini Mental Examination for Parkinson.
Key exclusion criteria (6 listed)
- individuals with rheumatologic or orthopedic diseases or deformities / abnormalities in the spine that compromise the respiratory mechanics;
- respiratory comorbidities;
- history of smoking;
- history of thoracic or abdominal surgery;
- clinical instability characterized by infections and / or hemodynamic defined as greater than 150 bpm heart rate or systolic blood pressure less than 90 mmHg;
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 |
|---|---|---|
| PNFRESPIRATORY PATTERN PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION | Other | GPNF |
| treadmillAEROBIC TRAINING | Device | GCONTROL, GPNF |
Primary outcome
LUNG VOLUME
Time frame: 1 MONTH
BY OPTOELECTRONIC PLETHYSMOGRAPHY
WALKING DISTANCE, VO2, VCO2
Time frame: 1 MONTH
SIX-MINUTE WALK TEST PLUS CÓRTEX
2 secondary outcomes
DIAPHRAGM MOBILITY
Time frame: 1 MONTH
DIAPHRAGM THICKNESS
Time frame: 1 MONTH
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
- Background: PubMed 23479031Costa A, Bagoj E, Monaco M, Zabberoni S, De Rosa S, Mundi C, Caltagirone C, Carlesimo GA. Mini mental Parkinson test: standardization and normative data on an Italian sample. Neurol Sci. 2013 Oct;34(10):1797-803. doi: 10.1007/s10072-013-1342-8. Epub 2013 Mar 12.
- Background: PubMed 23423464Isella V, Mapelli C, Morielli N, De Gaspari D, Siri C, Pezzoli G, Antonini A, Poletti M, Bonuccelli U, Picchi L, Napolitano A, Vista M, Greco A, Appollonio IM. Validity and metric of MiniMental Parkinson and MiniMental State Examination in Parkinson's disease. Neurol Sci. 2013 Oct;34(10):1751-8. doi: 10.1007/s10072-013-1328-6. Epub 2013 Feb 20.
- Background: PubMed 25609935Carvalho A, Barbirato D, Araujo N, Martins JV, Cavalcanti JL, Santos TM, Coutinho ES, Laks J, Deslandes AC. Comparison of strength training, aerobic training, and additional physical therapy as supplementary treatments for Parkinson's disease: pilot study. Clin Interv Aging. 2015 Jan 7;10:183-91. doi: 10.2147/CIA.S68779. eCollection 2015.
- Background: PubMed 17982531Pereira CA, Sato T, Rodrigues SC. New reference values for forced spirometry in white adults in Brazil. J Bras Pneumol. 2007 Jul-Aug;33(4):397-406. doi: 10.1590/s1806-37132007000400008. English, Portuguese.
- Background: PubMed 14533277Aliverti A, Pedotti A. Opto-electronic plethysmography. Monaldi Arch Chest Dis. 2003 Jan-Mar;59(1):12-6.
- Background: PubMed 21144957Testa A, Soldati G, Giannuzzi R, Berardi S, Portale G, Gentiloni Silveri N. Ultrasound M-mode assessment of diaphragmatic kinetics by anterior transverse scanning in healthy subjects. Ultrasound Med Biol. 2011 Jan;37(1):44-52. doi: 10.1016/j.ultrasmedbio.2010.10.004.
- Background: PubMed 10412550Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. doi: 10.1590/s0100-879x1999000600007.
- Background: PubMed 36867111Erratum: "Spirometry: step by step". V.C. Moore. Breathe 2012; 8: 232-240. Breathe (Sheff). 2022 Sep;18(3):115217. doi: 10.1183/20734735.5217-2011. Epub 2022 Nov 15.
- Background: PubMed 15994402Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. General considerations for lung function testing. Eur Respir J. 2005 Jul;26(1):153-61. doi: 10.1183/09031936.05.00034505. No abstract available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF and treadmill in people with Parkinson Disease, run by Universidade Federal de Pernambuco at 1 site 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Rego Barros (+55 81 21268496, carlosregobarros@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LUNG VOLUME (time frame: 1 MONTH). 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 NCT02600052, which also lists 9 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 23 Jun 2016.