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

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
PNF
treadmill
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade Federal de PernambucoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GPNF

GCONTROL

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

LUNG VOLUME
BY OPTOELECTRONIC PLETHYSMOGRAPHY
WALKING DISTANCE, VO2, VCO2
SIX-MINUTE WALK TEST PLUS CÓRTEX

Secondary Outcome Measures

DIAPHRAGM MOBILITY
ULTRASOUND
DIAPHRAGM THICKNESS
ULTRASOUND

Full Information

First Posted
November 3, 2015
Last Updated
June 22, 2016
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT02600052
Brief Title
Efficacy of Pattern Respiratory PNF Associated Aerobic Training on Lung Volumes and 6MWT Test in Parkinson Individuals
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 Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GPNF
Arm Type
Experimental
Arm Description
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.
Arm Title
GCONTROL
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PNF
Intervention Description
RESPIRATORY PATTERN PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION
Intervention Type
Device
Intervention Name(s)
treadmill
Intervention Description
AEROBIC TRAINING
Primary Outcome Measure Information:
Title
LUNG VOLUME
Description
BY OPTOELECTRONIC PLETHYSMOGRAPHY
Time Frame
1 MONTH
Title
WALKING DISTANCE, VO2, VCO2
Description
SIX-MINUTE WALK TEST PLUS CÓRTEX
Time Frame
1 MONTH
Secondary Outcome Measure Information:
Title
DIAPHRAGM MOBILITY
Description
ULTRASOUND
Time Frame
1 MONTH
Title
DIAPHRAGM THICKNESS
Description
ULTRASOUND
Time Frame
1 MONTH
Other Pre-specified Outcome Measures:
Title
PRESSURE RESPIRATORY MAXIMAL
Description
BY MANOVACUOMETER
Time Frame
1 MONTH

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Rego Barros
Phone
+55 81 21268496
Email
carlosregobarros@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Armele Dornelas
Phone
+55 81 21268496
Email
armeledornelas@yahoo.com
Facility Information:
Facility Name
Universidade Federal de Pernambuco
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50740560
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Rego Barros
Phone
+55 81 21268496
Email
carlosregobarros@hotmail.com
First Name & Middle Initial & Last Name & Degree
Armele Dornelas
Phone
+55 81 21268496
Email
armeledornelas@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
23479031
Citation
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Citation
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Efficacy of Pattern Respiratory PNF Associated Aerobic Training on Lung Volumes and 6MWT Test in Parkinson Individuals

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