NCT02600052

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 23, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

November 3, 2015

Last Update Submit

June 22, 2016

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

  • LUNG VOLUME

    BY OPTOELECTRONIC PLETHYSMOGRAPHY

    1 MONTH

  • WALKING DISTANCE, VO2, VCO2

    SIX-MINUTE WALK TEST PLUS CĂ“RTEX

    1 MONTH

Secondary Outcomes (2)

  • DIAPHRAGM MOBILITY

    1 MONTH

  • DIAPHRAGM THICKNESS

    1 MONTH

Other Outcomes (1)

  • PRESSURE RESPIRATORY MAXIMAL

    1 MONTH

Study Arms (2)

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.

Other: PNFDevice: 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.

Device: treadmill

Interventions

PNFOTHER

RESPIRATORY PATTERN PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION

GPNF
treadmillDEVICE

AEROBIC TRAINING

GCONTROLGPNF

Eligibility Criteria

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

You may qualify if:

  • Individuals with stage II and III between the Hoehn and Yahr classification;
  • minimum score of 28 on the Mini Mental Examination for Parkinson.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, 50740560, Brazil

RECRUITING

Related Publications (9)

  • 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.

    PMID: 23479031BACKGROUND

  • Isella 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.

    PMID: 23423464BACKGROUND

  • Carvalho 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.

    PMID: 25609935BACKGROUND

  • Pereira 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.

    PMID: 17982531BACKGROUND

  • Aliverti A, Pedotti A. Opto-electronic plethysmography. Monaldi Arch Chest Dis. 2003 Jan-Mar;59(1):12-6.

    PMID: 14533277BACKGROUND

  • Testa 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.

    PMID: 21144957BACKGROUND

  • Neder 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.

    PMID: 10412550BACKGROUND

  • MOORE, V. C. Spirometry: Step by step. Breathe, v. 8, n. 3, p. 233-240, 2012

    BACKGROUND

  • Miller 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.

    PMID: 15994402BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Central Study Contacts

Carlos Rego Barros

CONTACT

+55 81 21268496carlosregobarros@hotmail.com

Armele Dornelas

CONTACT

+55 81 21268496armeledornelas@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher master

Study Record Dates

First Submitted

November 3, 2015

First Posted

November 9, 2015

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Study Completion

April 1, 2017

Last Updated

June 23, 2016

Record last verified: 2016-01

Locations

BR(1)