AzTrials
AzTrials

Parkinson DiseaseNCT04135924

Influence of Trainning in Parkinson's Disease

A study testing Rehabilitation in people with Parkinson Disease, run by Universidade Metodista de Piracicaba at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 55 to 75 years
Conditions the study is for
Parkinson Disease
What is being tested?
Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBrazil
Study dates
1 Apr 2019to 1 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Larissa S Rocha, Phd contact

+5591991209221

lari1980@gmail.com

Brazil1 site, 1 recruiting
  • Universidade do Estado do Pará

    Belém, Pará, 66055-490

    Rodrigo S Rocha, Phd, 91992340234, fisiorocha2000@yahoo.com.br

    Recruiting

Other trials in Brazil

About this study

Official title: Influence of Trainning Respiratory Muscle About Gate and Physiological and Functional Variables in Parkinson's Disease

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.

Read more

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.

Read the 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.

Being tested
Rehabilitation
Keywords
Rehabilitation, Neurological disease
Medical subject headings
Parkinson Disease, Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RehabilitationOther

    physical exercise and respiratory muscle training

Study groups in NCT04135924
Study groupRoleWhat they receive
walking nordic and respiratory training groupActive comparatorIt 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 .
Receives: Other: Rehabilitation
walking nordic groupActive comparatorIt will be composed of patients with clinical diagnosis of Parkinson's disease, who will only be submitted to Nordic walking training.
Receives: Other: Rehabilitation
respiratory training groupActive comparatorIt will be composed of patients with clinical diagnosis of Parkinson's disease, who will only be submitted to respiratory muscle training protocol.
Receives: Other: Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement of lipid peroxidation

    Oxigen-reactive species

    Measured: 8 weeks

  2. Respiratory function

    spirometry variables analysis

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2019
  2. Study start1 Apr 2019
  3. Primary completion1 Dec 2019 (estimated)
  4. Study completion1 Jul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized clinical trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04135924
Sponsor's protocol ID
031.819.852-52
Status last verified
Oct 2019
First submitted
28 Mar 2019
Last updated
23 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 23720332
  • Hoehn MM, Yahr MD. Parkinsonism: onset, progression, and mortality. 1967. Neurology. 2001 Nov;57(10 Suppl 3):S11-26. No abstract available.

    PubMed 11775596
  • 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.

    PubMed 29756459
  • 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.

    PubMed 23714850
  • 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.

    PubMed 38588457
  • 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.

    PubMed 36602886

Questions about this trial

What is this clinical trial studying?

A study testing Rehabilitation in people with Parkinson Disease, run by Universidade Metodista de Piracicaba at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Larissa S Rocha, Phd (+5591991209221, lari1980@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of lipid peroxidation (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04135924, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in