search
Back to results

Influence of Trainning in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Rehabilitation
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 focused on measuring Rehabilitation, Neurological disease

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • without cognitive impairment
  • Mini Mental State Examination with scores above 23
  • clinical diagnosis of Parkinson's disease in grade 2-3 on the scale modified Hoehn and Yarh

Exclusion Criteria:

  • volunteers who present cognitive, auditory and visual alterations, that incapacitate them to carry out the proposed procedure
  • carriers of Diabetes Mellitus and other metabolic diseases
  • heart disease and uncontrolled hypertension
  • ethyl alcohol
  • smoker
  • those hospitalized at least six months prior to the study
  • as well as those who do not use the medication and the correct dosage prescribed by the physician
  • individuals with osteomioarticular dysfunctions and neurological diseases
  • restricted to wheelchairs

Sites / Locations

  • Universidade do Estado do ParáRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

walking nordic and respiratory training group

walking nordic group

respiratory training group

Arm Description

It will be composed of patients with clinical diagnosis of Parkinson's disease, who will be submitted to respiratory muscle training (TMR) associated with the Nordic walking(NC) training .

It will be composed of patients with clinical diagnosis of Parkinson's disease, who will only be submitted to Nordic walking training.

It will be composed of patients with clinical diagnosis of Parkinson's disease, who will only be submitted to respiratory muscle training protocol.

Outcomes

Primary Outcome Measures

Measurement of lipid peroxidation
Oxigen-reactive species
Respiratory function
spirometry variables analysis

Secondary Outcome Measures

Full Information

First Posted
March 28, 2019
Last Updated
October 21, 2019
Sponsor
Universidade Metodista de Piracicaba
Collaborators
Universidade do Estado do Pará
search

1. Study Identification

Unique Protocol Identification Number
NCT04135924
Brief Title
Influence of Trainning in Parkinson's Disease
Official Title
Influence of Trainning Respiratory Muscle About Gate and Physiological and Functional Variables in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)

3. Sponsor/Collaborators

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

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 a neurodegenerative disorder of the central nervous system (CNS), chronic and progressive that is associated with the loss of dopaminergic neurons in the compact part of the substantia nigra. These patients often show excessive fatigue and dyspnea with the progression of the disease, and the later onset of treatment, lower the tolerance of the patient to perform physical activities. Walking is one of the main limiting factors for a good quality of life. Therefore, gait training can promote individuals a better physical condition to recover their activities, as well as to maintain good posture, and reduce exacerbated flexion of the characteristic spine, preventing falls and various types of trauma. A proposed gait training is the Nordic walk, which, when using sticks to gain balance, stability and coordination, allows the individual to obtain better functional capacity, besides performing aerobic and stimulating activity. In addition to the gait training, this research proposes respiratory muscle training (TMR), using a linear resistor capable of promoting resistance and strength gain of the inspiratory musculature. TMR is a therapeutic modality consecrated in the maximal inspiratory and expiratory pressure gain, directly influencing the peripheral musculature, favoring the practice of physical activities, such as walking itself to possibly condition the patient to longevity and dignity to practice their ADLs with better quality of life, allowing delayed disease progression. In addition, the practice of these individuals submitted to walking and respiratory muscle training protocols can bring great benefits as regards their quality of life, and their perception of space, as well as their importance in the social environment. One form of evidence to qualify these aspects is the quality of life assessment scale in PDQ-39 Parkinson's Disease Patients, which contributes among other factors to the satisfaction and performance of the activity.
Detailed Description
Parkinson's disease (PD) is a neurodegenerative disorder of the central nervous system (CNS), chronic and progressive that is associated with the loss of dopaminergic neurons in the compact part of the substantia nigra ( AYANO , 2016). Its clinical diagnosis is due to a set of signs and symptoms, initially observed for the motor characteristics that may be: rest tremor, bradykinesia, postural instability, festinating gait and joint stiffness, which directly interfere in the quality of life of these individuals ( CUGUSI and t al., 2017). Some studies have shown that patients with PD exhibit multiple respiratory symptoms , including reduced respiratory muscle strength, rapid and coordinated action performance impairment, efficient contractions of the chest wall musculature, and effective cough reduction. With the progression of the disease, these limitations can trigger aspiration pneumonia, which is the main cause of death in this profile of individuals ( TROCHE et al ., 2010 ; SAPIENZA et al., 2011; JÚNIOR et al., 2015 ). From the epidemiological point of view, feta accounts for about 1% of the population over 65 years and more than 3% after 75 years of age, with an incidence of 1.5 men over women. ( SILVA, 2018). The projection for 2030 is that more than 8 million individuals over the age of 60 have Parkinson's disease. In the United States about 59,000 new cases emerge every year. In Brazil, epidemiological data on the disease are still scarce, but it is estimated that around 200,000 people have the disease ( FERNANDES; FILHO, 2018 ). These patients often show excessive fatigue and dyspnea with the progression of the disease, and the later onset of treatment, lower the tolerance of the patient to perform physical activities.Therefore, it is sought through health promotion to guide the need for physical practice through exercises that can contribute to the improvement of their quality of life and in the previous training of the respiratory muscles, influencing the main functional skills, such as am archa. ( REYES, CASTILLO et al., 2018; RASSLER et al., 2011). Walking is one of the main limiting factors for a good quality of life. Therefore, gait training can promote individuals a better physical condition to recover their activities, as well as to maintain good posture, and reduce exacerbated flexion of the characteristic spine, preventing falls and various types of trauma. A proposed gait training is the Nordic walk, which, when using sticks to gain balance, stability and coordination, allows the individual to obtain better functional capacity, besides performing aerobic and stimulating activity (XU et al., 2018) . In addition to the gait training, this research proposes respiratory muscle training (TMR), using a linear resistor capable of promoting resistance and strength gain of the inspiratory musculature. TMR is a therapeutic modality consecrated in the maximal inspiratory and expiratory pressure gain, directly influencing the peripheral musculature, favoring the practice of physical activities, such as walking itself to possibly condition the patient to longevity and dignity to practice their ADLs with better quality of life, allowing delayed disease progression (Júnior et al., 2015). In addition, the practice of these individuals submitted to walking and respiratory muscle training protocols can bring great benefits as regards their quality of life, and their perception of space, as well as their importance in the social environment. One form of evidence to qualify these aspects is the quality of life assessment scale in PDQ-39 Parkinson's Disease Patients, which contributes among other factors to the satisfaction and performance of the activity (JA et al., 2012; ). Thus, the objective of this study is to verify the influence of respiratory muscle training associated with Nordic walking training on the physiological, biochemical and functional variables in patients with Parkinson's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Rehabilitation, Neurological disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized clinical trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
walking nordic and respiratory training group
Arm Type
Active Comparator
Arm Description
It will be composed of patients with clinical diagnosis of Parkinson's disease, who will be submitted to respiratory muscle training (TMR) associated with the Nordic walking(NC) training .
Arm Title
walking nordic group
Arm Type
Active Comparator
Arm Description
It will be composed of patients with clinical diagnosis of Parkinson's disease, who will only be submitted to Nordic walking training.
Arm Title
respiratory training group
Arm Type
Active Comparator
Arm Description
It will be composed of patients with clinical diagnosis of Parkinson's disease, who will only be submitted to respiratory muscle training protocol.
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
physical exercise and respiratory muscle training
Primary Outcome Measure Information:
Title
Measurement of lipid peroxidation
Description
Oxigen-reactive species
Time Frame
8 weeks
Title
Respiratory function
Description
spirometry variables analysis
Time Frame
8 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: without cognitive impairment Mini Mental State Examination with scores above 23 clinical diagnosis of Parkinson's disease in grade 2-3 on the scale modified Hoehn and Yarh Exclusion Criteria: volunteers who present cognitive, auditory and visual alterations, that incapacitate them to carry out the proposed procedure carriers of Diabetes Mellitus and other metabolic diseases heart disease and uncontrolled hypertension ethyl alcohol smoker those hospitalized at least six months prior to the study as well as those who do not use the medication and the correct dosage prescribed by the physician individuals with osteomioarticular dysfunctions and neurological diseases restricted to wheelchairs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Larissa S Rocha, Phd
Phone
+5591991209221
Email
lari1980@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucas M Matos, graduated
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo S Rocha, Phd
Phone
91992340234
Email
fisiorocha2000@yahoo.com.br

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23720332
Citation
Earhart GM, Falvo MJ. Parkinson disease and exercise. Compr Physiol. 2013 Apr;3(2):833-48. doi: 10.1002/cphy.c100047.
Results Reference
result
PubMed Identifier
11775596
Citation
Hoehn MM, Yahr MD. Parkinsonism: onset, progression, and mortality. 1967. Neurology. 2001 Nov;57(10 Suppl 3):S11-26. No abstract available.
Results Reference
result
PubMed Identifier
29756459
Citation
Reyes A, Castillo A, Castillo J, Cornejo I. The effects of respiratory muscle training on peak cough flow in patients with Parkinson's disease: a randomized controlled study. Clin Rehabil. 2018 Oct;32(10):1317-1327. doi: 10.1177/0269215518774832. Epub 2018 May 13.
Results Reference
result
PubMed Identifier
23714850
Citation
Reyes A, Ziman M, Nosaka K. Respiratory muscle training for respiratory deficits in neurodegenerative disorders: a systematic review. Chest. 2013 May;143(5):1386-1394. doi: 10.1378/chest.12-1442.
Results Reference
result

Learn more about this trial

Influence of Trainning in Parkinson's Disease

We'll reach out to this number within 24 hrs