Clinical trial NCT04135924: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Rehabilitation
Neurological disease
Lead sponsor: Universidade Metodista de Piracicaba
Sponsor class: OTHER
Collaborators: name: Universidade do Estado do Pará
First posted: 2019-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Measurement of lipid peroxidation
timeFrame: 8 weeks
measure: Respiratory function
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Universidade do Estado do Pará
state: Pará
Study officials:
affiliation: Universidade do Estado do Pará
name: Lucas M Matos, graduated
role: STUDY_CHAIR
References:
citation: Earhart GM, Falvo MJ. Parkinson disease and exercise. Compr Physiol. 2013 Apr;3(2):833-48. doi: 10.1002/cphy.c100047.
citation: Hoehn MM, Yahr MD. Parkinsonism: onset, progression, and mortality. 1967. Neurology. 2001 Nov;57(10 Suppl 3):S11-26. No abstract available.
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.
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.