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Completed

NCT Number: NCT04108520

Diaphragmatic Exercise on Parkinson Disease

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.

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade do Estado do Pará

Belém, Pará, 66055-490, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

Exercise with respiratory training

Primary outcomes

  1. Respiratory muscle strength

    Time frame: post treatment in 3 days

    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.

Sponsors and collaborators

Lead sponsor

Universidade Metodista de Piracicaba

Other

Registry information

Official study title

Association of Diaphragmatic Exercises With the Functional Rehabilitation Protocol Effects on the Pulmonary Function of Individuals With Parkinson's Disease

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 30, 2019
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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