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Diaphragmatic Exercise on Parkinson Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise
Sponsored by
Universidade Metodista de Piracicaba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Parkinson's of both genders
  • No reports of respiratory diseases and / or other previous neurological complications in the assessment form
  • Residents in the metropolitan area of Belém.

Exclusion Criteria:

  • Patients with cognitive impairment or dementia
  • Patients with previous respiratory conditions or another neurological condition.
  • Patients with two consecutive absences or four absences alternating with treatment.

Sites / Locations

  • Universidade do Estado do Pará

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

Exercises on respiratory muscle, 3 times per week, 1 hour peer day

Outcomes

Primary Outcome Measures

Respiratory muscle strength
A digital manovacuometer will be used to measure respiratory muscle strength, providing maximum inspiratory pressure and Maximum Expiratory Pressure. A nasal clip will be used throughout the procedure to avoid air leakage. Thus, in order to obtain the measures of MIP, the volunteer is instructed to perform a maximal expiration and soon afterwards, through vocal encouragement, the individual will perform a maximum and sustained inspiratory effort for at least 2 seconds. Also, for the values of MEP, where the participant will perform a maximum inspiration before the maximum sustained respiratory effort. The PImax and PEmax maneuvers will first be learned, being executed 3 times by each member, adopting the values consistent with each other, with a difference of 10% between each result.

Secondary Outcome Measures

Full Information

First Posted
September 25, 2019
Last Updated
August 11, 2020
Sponsor
Universidade Metodista de Piracicaba
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1. Study Identification

Unique Protocol Identification Number
NCT04108520
Brief Title
Diaphragmatic Exercise on Parkinson Disease
Official Title
Association of Diaphragmatic Exercises With the Functional Rehabilitation Protocol Effects on the Pulmonary Function of Individuals With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Metodista de Piracicaba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Parkinson's disease (PD) is the second most common neurodegenerative disease in the world, considering the central nervous system disorders that affect movement. In addition to motor impairment, the literature reinforces changes in ventilatory parameters, such as restrictive lung dysfunction, obstructive airway disease, and upper airway obstruction. Pulmonary disorders are more evident in patients in later and advanced stages of PD, and are responsible for most of the morbimortalities resulting from the disease. Objectives: To evaluate the effects of a protocol of diaphragmatic awareness, in association with the global exercises, on the pulmonary function of individuals with Parkinson's disease. Methods: This is an experimental, uncontrolled clinical trial. Participants are patients with Parkinson's disease referred for care at the UEAFTO / CER-II UEPA neurofunctional outpatient clinic whose records will be consulted for the collection of epidemiological data and postural assessment of cognitive functions through protocol Montreal Cognitive Assessment (Brazilian experimental version) and classification by modified Hoehn and Yahr scale. Those who meet the inclusion criteria will be evaluated through the evaluation form, Pulmonary Functional Status and Dyspnea Questionnair protocol, submitted to Pulmonary Function Test and respiratory muscle strength assessment by Spirometry and Manovacuometry, respectively. They will be submitted to an intervention protocol prepared by the physiotherapy team of UEPA's Elderly Care Center for 20 sessions lasting 60 minutes twice a week, consisting of global exercises and diaphragmatic awareness, being re-evaluated in the 10th and 20th sessions. The protocol used will be registered in the Clinical Trials database. All participants will sign a Free and Informed Consent Form and the research will be submitted to analysis by the Human Research Ethics Committee of the University of the State of Pará (UEPA). The data collected will be tabulated in a Microsoft Excel 2016® worksheet for further statistical analysis using BioEstat® 5.3 software. Expected results: obtain an improvement in the variables related to pulmonary function in the experimental group after the application of the intervention protocol and in relation to the control group.
Detailed Description
Parkinson's disease (PD) is the second most common neurodegenerative disease in the world, considering the central nervous system disorders that affect movement. In addition to motor impairment, the literature reinforces changes in ventilatory parameters, such as restrictive lung dysfunction, obstructive airway disease, and upper airway obstruction. Pulmonary disorders are more evident in patients in later and advanced stages of PD, and are responsible for most of the morbimortalities resulting from the disease. Objectives: To evaluate the effects of a protocol of diaphragmatic awareness, in association with the global exercises, on the pulmonary function of individuals with Parkinson's disease. Methods: This is an experimental, uncontrolled clinical trial. Participants are patients with Parkinson's disease referred for care at the UEAFTO / CER-II UEPA neurofunctional outpatient clinic whose records will be consulted for the collection of epidemiological data and postural assessment of cognitive functions through protocol Montreal Cognitive Assessment (Brazilian experimental version) and classification by modified Hoehn and Yahr scale. Those who meet the inclusion criteria will be evaluated through the evaluation form, Pulmonary Functional Status and Dyspnea Questionnair protocol, submitted to Pulmonary Function Test and respiratory muscle strength assessment by Spirometry and Manovacuometry, respectively. They will be submitted to an intervention protocol prepared by the physiotherapy team of UEPA's Elderly Care Center for 20 sessions lasting 60 minutes twice a week, consisting of global exercises and diaphragmatic awareness, being re-evaluated in the 10th and 20th sessions. The protocol used will be registered in the Clinical Trials database. All participants will sign a Free and Informed Consent Form and the research will be submitted to analysis by the Human Research Ethics Committee of the University of the State of Pará (UEPA). The data collected will be tabulated in a Microsoft Excel 2016® worksheet for further statistical analysis using BioEstat® 5.3 software. Expected results: to obtain an improvement in the variables related to pulmonary function in the experimental group after the application of the intervention protocol and in relation to the control group.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Exercises on respiratory muscle, 3 times per week, 1 hour peer day
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Exercise with respiratory training
Primary Outcome Measure Information:
Title
Respiratory muscle strength
Description
A digital manovacuometer will be used to measure respiratory muscle strength, providing maximum inspiratory pressure and Maximum Expiratory Pressure. A nasal clip will be used throughout the procedure to avoid air leakage. Thus, in order to obtain the measures of MIP, the volunteer is instructed to perform a maximal expiration and soon afterwards, through vocal encouragement, the individual will perform a maximum and sustained inspiratory effort for at least 2 seconds. Also, for the values of MEP, where the participant will perform a maximum inspiration before the maximum sustained respiratory effort. The PImax and PEmax maneuvers will first be learned, being executed 3 times by each member, adopting the values consistent with each other, with a difference of 10% between each result.
Time Frame
post treatment in 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parkinson's of both genders No reports of respiratory diseases and / or other previous neurological complications in the assessment form Residents in the metropolitan area of Belém. Exclusion Criteria: Patients with cognitive impairment or dementia Patients with previous respiratory conditions or another neurological condition. Patients with two consecutive absences or four absences alternating with treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorena ZAHLUTH, phd
Organizational Affiliation
Universidade do Estado do Pará
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade do Estado do Pará
City
Belém
State/Province
Pará
ZIP/Postal Code
66055-490
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Diaphragmatic Exercise on Parkinson Disease

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