Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Pattern Respiratory PNF Associated Aerobic Training on Lung Volumes and 6MWT Test in Parkinson Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02600052
Recruitment Status : Unknown
Verified January 2016 by Carlos Rego Barros, Universidade Federal de Pernambuco.
Recruitment status was:  Recruiting
First Posted : November 9, 2015
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Carlos Rego Barros, Universidade Federal de Pernambuco

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: PNF Device: treadmill Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : May 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GPNF
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: PNF
RESPIRATORY PATTERN PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION

Device: treadmill
AEROBIC TRAINING

Active Comparator: GCONTROL
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
AEROBIC TRAINING




Primary Outcome Measures :
  1. LUNG VOLUME [ Time Frame: 1 MONTH ]
    BY OPTOELECTRONIC PLETHYSMOGRAPHY

  2. WALKING DISTANCE, VO2, VCO2 [ Time Frame: 1 MONTH ]
    SIX-MINUTE WALK TEST PLUS CÓRTEX


Secondary Outcome Measures :
  1. DIAPHRAGM MOBILITY [ Time Frame: 1 MONTH ]
    ULTRASOUND

  2. DIAPHRAGM THICKNESS [ Time Frame: 1 MONTH ]
    ULTRASOUND


Other Outcome Measures:
  1. PRESSURE RESPIRATORY MAXIMAL [ Time Frame: 1 MONTH ]
    BY MANOVACUOMETER



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600052


Contacts
Layout table for location contacts
Contact: Carlos Rego Barros +55 81 21268496 carlosregobarros@hotmail.com
Contact: Armele Dornelas +55 81 21268496 armeledornelas@yahoo.com

Locations
Layout table for location information
Brazil
Universidade Federal de Pernambuco Recruiting
Recife, Pernambuco, Brazil, 50740560
Contact: Carlos Rego Barros    +55 81 21268496    carlosregobarros@hotmail.com   
Contact: Armele Dornelas    +55 81 21268496    armeledornelas@yahoo.com   
Sponsors and Collaborators
Universidade Federal de Pernambuco
Publications:
ALIVERTI A, PEDOTTI A. Opto-electronic Plethysmography. v. c, 2002.
MOORE, V. C. Spirometry: Step by step. Breathe, v. 8, n. 3, p. 233-240, 2012

Layout table for additonal information
Responsible Party: Carlos Rego Barros, researcher master, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02600052    
Other Study ID Numbers: 06704028420
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases