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.
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.
Brazil1 site, 1 recruiting
- Recruiting
Universidade do Estado do Pará
Belém, Pará, 66055-490
Rodrigo S Rocha, Phd, 91992340234, fisiorocha2000@yahoo.com.br
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.
- Conditions
- Parkinson 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 group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. Receives: 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. Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of lipid peroxidation
Oxigen-reactive species
Measured: 8 weeks
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.
- First posted23 Oct 2019
- Study start1 Apr 2019
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universidade Metodista de Piracicaba
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Estado do Pará
- Responsible party
- Principal investigator, Rodrigo Santiago Barbosa Rocha, Phd, Universidade Metodista de Piracicaba
- Investigators
- Lucas M Matos, graduated, Study chair, Universidade do Estado do Pará
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 23720332Hoehn MM, Yahr MD. Parkinsonism: onset, progression, and mortality. 1967. Neurology. 2001 Nov;57(10 Suppl 3):S11-26. No abstract available.
PubMed 11775596Reyes 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 29756459Reyes 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 23714850Ernst 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 38588457Ernst 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Trainning Respiratory Muscle About Gate and Physiological and Functional Variables in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04135924
- Acronym / sponsor ID
- 031.819.852-52
- Conditions
- Parkinson Disease
- Keywords
- Rehabilitation, Neurological disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Collaborators
- Universidade do Estado do Pará
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| walking nordic and respiratory training group | Active comparator | Other: RehabilitationIt 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 . |
| walking nordic group | Active comparator | Other: RehabilitationIt will be composed of patients with clinical diagnosis of Parkinson's disease, who will only be submitted to Nordic walking training. |
| respiratory training group | Active comparator | Other: RehabilitationIt will be composed of patients with clinical diagnosis of Parkinson's disease, who will only be submitted to respiratory muscle training protocol. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitationphysical exercise and respiratory muscle training | Other | respiratory training group, walking nordic and respiratory training group, walking nordic group |
Primary outcome
Measurement of lipid peroxidation
Time frame: 8 weeks
Oxigen-reactive species
Respiratory function
Time frame: 8 weeks
spirometry variables analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Results publication: PubMed 23720332Earhart GM, Falvo MJ. Parkinson disease and exercise. Compr Physiol. 2013 Apr;3(2):833-48. doi: 10.1002/cphy.c100047.
- Results publication: PubMed 11775596Hoehn MM, Yahr MD. Parkinsonism: onset, progression, and mortality. 1967. Neurology. 2001 Nov;57(10 Suppl 3):S11-26. No abstract available.
- Results publication: PubMed 29756459Reyes 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 publication: PubMed 23714850Reyes 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.
- Derived from this study: PubMed 38588457Ernst 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.
- Derived from this study: PubMed 36602886Ernst 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas M Matos, graduated study chair
Universidade do Estado do Pará
1 site in 1 country: see every site and its status.
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.