NCT04135924

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

March 28, 2019

Last Update Submit

October 21, 2019

Conditions

Keywords

RehabilitationNeurological disease

Outcome Measures

Primary Outcomes (2)

  • Measurement of lipid peroxidation

    Oxigen-reactive species

    8 weeks

  • Respiratory function

    spirometry variables analysis

    8 weeks

Study Arms (3)

walking nordic and respiratory training group

ACTIVE COMPARATOR

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 .

Other: Rehabilitation

walking nordic group

ACTIVE COMPARATOR

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

Other: Rehabilitation

respiratory training group

ACTIVE COMPARATOR

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

Other: Rehabilitation

Interventions

physical exercise and respiratory muscle training

respiratory training groupwalking nordic and respiratory training groupwalking nordic group

Eligibility Criteria

Age55 Years - 75 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade do Estado do Pará

Belém, Pará, 66055-490, Brazil

RECRUITING

Related Publications (6)

  • Earhart GM, Falvo MJ. Parkinson disease and exercise. Compr Physiol. 2013 Apr;3(2):833-48. doi: 10.1002/cphy.c100047.

  • Hoehn MM, Yahr MD. Parkinsonism: onset, progression, and mortality. 1967. Neurology. 2001 Nov;57(10 Suppl 3):S11-26. No abstract available.

  • 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.

  • 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.

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

MeSH Terms

Conditions

Parkinson DiseaseNervous System Diseases

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Lucas M Matos, graduated

    Universidade do Estado do Pará

    STUDY CHAIR

Central Study Contacts

Larissa S Rocha, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Human Movement Department

Study Record Dates

First Submitted

March 28, 2019

First Posted

October 23, 2019

Study Start

April 1, 2019

Primary Completion

December 1, 2019

Study Completion

July 1, 2020

Last Updated

October 23, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations