Parkinson DiseaseNCT04251728
Effects of AMPS on Cardiovascular and Functional Variables in Patients With Parkinson's Disease
A study testing Automated mechanical peripheral stimulation and Physical Exercise in people with Parkinson Disease, run by Universidad Católica del Maule at 1 site in Chile.
Trial summary
This study evaluates the addition of automated mechanical peripheral stimulation (AMPS) to physical exercise in the treatment of cardiovascular and motor disabilities in Parkinson's patients. Half of participants will receive AMPS and exercise, while the other half will receive a simulated session (SHAM) and exercise. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Automated mechanical peripheral stimulation and Physical Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- 30 Mar 2022to 30 Dec 2022
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of idiopathic Parkinson's disease
- Scoring 1 to 3 on the Hoehn and Yhar scale
- Pharmacological treatment unchanged for at least 30 days prior the study
Who cannot join
- Signs of cognitive decline, based on the results of the Mini Mental State Examination
- Cardiorespiratory, neuromuscular and musculoskeletal diseases not related to PD
- Sensory peripheral neuropathy, diabetes or any other disease known to promote autonomic dysfunction
- Changes in pharmacological treatment after inclusion in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Effects of Automated Mechanical Peripheral Stimulation on Cardiovascular and Functional Variables in Patients With Parkinson's Disease
This study evaluates the addition of automated mechanical peripheral stimulation (AMPS) to physical exercise in the treatment of cardiovascular and motor disabilities in Parkinson's patients. Half of participants will receive AMPS and exercise, while the other half will receive a simulated session (SHAM) and exercise.
Read the detailed description
Cardiovascular abnormalities are frequent in Parkinson's disease (PD) even in the early stages. As consequence, patients may experience orthostatic hypotension and/or arterial hypertension in the supine posture, especially at night. Thus, the management of dysautonomia in patients with PD is challenging.
Automated mechanical peripheral stimulation (AMPS) has been recently proposed as therapy for motor and cardiovascular improvements in patients with PD. On the other hand, physical exercise has been recommended for patients with PD showing to be effective in improving physical conditioning and cognitive function.
However, the combined effects of AMPS and exercise on cardiovascular variables and functional capacity of patients with PD are still unknown.
Therefore, volunteers will be randomly allocated into two groups: 1) exercise group: will be submitted to a program of 24 exercise sessions, along with 2 weekly sessions of SHAM AMPS for 12 weeks. 2) AMPS groups: will be submitted to the program of 24 exercise sessions, along with 2 weekly sessions of AMPS during the same period.
AMPS sessions will be held prior to exercise sessions. Before and after the 12-week program, all volunteers will be submitted to assessments of cardiac autonomic control, timed up and go, and cardiopulmonary exercise testing to assess aerobic functional capacity.
The hypothesis is that the exercise program combined with AMPS therapy will provide greater improvement on the cardiovascular function and aerobic functional capacity in patients with PD, than the exercise program alone.
- Conditions
- Parkinson Disease
- Being tested
- Automated mechanical peripheral stimulation, Physical Exercise, SHAM
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated mechanical peripheral stimulationDevice
Also called Mechanical somatosensory stimulation, Gondola
Automated mechanical pressure reaching the pain threshold in four specific points at the foots soles
Physical ExerciseOther
Also called Exercise, Aerobic exercise
The exercise program will be conducted for 12 weeks lasting 1 hour each session. Sessions will be held in groups and each session will comprise 4 steps: 1) Warm-up (5 min): patients will perform stretching of the main muscle groups of upper limbs, lower limbs and trunk; 2) Aerobic exercise (30 min): patients will perform continuous aerobic exercise consisting of walk on flat ground and ramps; 3) Resistance exercise training (20 min): volunteers will perform resistance exercises (2 sets x 15 repetitions) for upper and lower limbs, and trunk working the following muscle groups: shoulder flexors, extensors and abductors; elbow flexors and extensors; trunk extensors and flexors; knee flexors and extensors; and dorsiflexors and plantar flexors; 4) Cool-down (5 min): Stretching of the main muscle groups worked during the sessions and relaxation.
SHAMDevice
Automated mechanical pressure reaching the sensory threshold in four specific points at the foots soles
| Study group | Role | What they receive |
|---|---|---|
| Exercise plus AMPS group (AMPS-G) | Experimental | Physical exercise and automated mechanical peripheral stimulation (AMPS) with intensity at the pain threshold, performed two times a week for 12 weeks. Receives: Device: Automated mechanical peripheral stimulation; Other: Physical Exercise |
| Exercise plus SHAM group (Exercise-G) | Sham comparator | Physical exercise and simulated automated mechanical peripheral stimulation (AMPS) with intensity at the sensory threshold performed two times a week for 12 weeks. Receives: Other: Physical Exercise; Device: SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB)
This standardized test evaluates the physical function of the lower extremities in older adults. It includes three parts: a standing balance test, a 4-meter gait speed assessment, and a chair stand test involving five consecutive sit-to-stand actions. Each part is rated on a scale from 0 (unable to perform) to 4 (optimal performance), resulting in a total score between 0 and 12 points. Higher scores indicate better physical performance, whereas lower scores indicate functional limitations.
Measured: 12 weeks
Peak oxygen uptake
An incremental ramp-type protocol exercise will be used to determine the participant's aerobic capacity. Oxygen uptake will be obtained on a breath-to-breath basis during the entire exercise using an expired gas measurement system.
Measured: 12 weeks
Parkinson's Disease Questionnaire 39 (PDQ-39)
This questionnaire is a disease-specific tool crafted to evaluate the health-related quality of life in individuals with PD. It comprises 39 items divided into eight dimensions: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Each item is rated on a five-point scale ranging from 0 (never) to 4 (always). Domain scores are then converted to a scale from 0 to 100, where higher scores signify a greater impact of the disease and, consequently, a poorer quality of life.
Measured: 12 weeks
Unified Parkinson's Disease Rating Scale Part III (UPDRS III)
It is the most widely applied rating instrument for measured motor symptoms in PD. Motor examination, including 18 items Some of them are for each of the upper and lower extremities, neck or jaw, and are scored according to severity from 0 (normal) to 4 (severe), which gives a final score that can vary between 0 to 132 points.
Measured: 12 weeks
Heart rate variability
Quantification of heart rate oscillation to assess the cardiac autonomic control. This is quantified by time-domain, spectral and non-linear analysis.
Measured: 12 weeks
Secondary outcomes (4)
Freezing of Gait Questionnaire (FOG-Q)
It is the only validated tool for the assessment of FOG severity in people with PD. FOG-Q total score ranges from 0 to 24 points and higher scores correspond to more severe FOG.
Measured: 12 weeks
Timed up and go
Time spent for the participant to rise from a standard chair without armrests, walk 3 meters straight at their preferred speed, turn, walk back to the chair and sit down again. Participants will perform the test twice and the lowest total duration will be considered as the outcome
Measured: 12 weeks
4-meter gait speed test (4mGT)
It is being used increasingly as both a stand-alone measure and as a component of the SPPB, and it is a reliable option to measure gait speed for older adults. The test was conducted in an unobstructed corridor measuring 8 meters in length. Two markers were positioned on the floor at the 2-meter and 6-meter points, thereby establishing a central walking distance of 4 meters. Participants were instructed to begin by standing with both feet behind the starting line and, upon the command "Go," to proceed at their usual, comfortable pace until they crossed the finish line. The time required to traverse the central 4 meters was recorded using a stopwatch. Gait speed was measured in seconds (s).
Measured: 12 weeks
5 times sit-to-stand test (5XSST)
Repeated performance of sit-to-stand has often been used as a measure of lower extremity strength in older people. It is also validated for people with PD with a sensitivity of 75%, and a specificity of 68%. The participants completed five repetitions of sit-to-stand from a standard chair (height: 0.49m) as quickly as possible upon hearing the cue "Ready, set, go!", measured in seconds.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start30 Mar 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)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
- A randomized, double-blind, two-arm, parallel-group study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica del Maule
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Responsible party
- Principal investigator, Antonio Roberto Zamunér, Universidad Católica del Maule
- Investigators
- Antonio R Zamunér, PhD, Principal investigator, Universidad Católica del Maule
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251728
- Sponsor's protocol ID
- 183/2018
- Status last verified
- Mar 2026
- First submitted
- 30 Jan 2020
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be shared upon request at the end of the study.
Publications
[1] Souza CFM, Almeida HCP, Souza JB, Costa PH, Silveira YSS, Bezerra JCL. A doença de Parkinson e o processo de envelhecimento motor: uma revisão da literatura. Revista de Neurociências, 2011. 19(4): p. 6.
Barbosa MT, Caramelli P, Maia DP, Cunningham MC, Guerra HL, Lima-Costa MF, Cardoso F. Parkinsonism and Parkinson's disease in the elderly: a community-based survey in Brazil (the Bambui study). Mov Disord. 2006 Jun;21(6):800-8. doi: 10.1002/mds.20806.
PubMed 16482566Chana C P, Jimenez C M, Diaz T V, Juri C. [Parkinson disease mortality rates in Chile]. Rev Med Chil. 2013 Mar;141(3):327-31. doi: 10.4067/S0034-98872013000300007. Spanish.
PubMed 23900323Rosa JdC, Cielo CA, Cechella C. Função fonatória em pacientes com doença de Parkinson: uso de instrumento de sopro. Revista CEFAC, 2009. 11: p. 305-313.
Teive HA, Bertucci DC Filho, Munhoz RP. Unusual motor and non-motor symptoms and signs in the early stage of Parkinson's disease. Arq Neuropsiquiatr. 2016 Oct;74(10):781-784. doi: 10.1590/0004-282X20160126.
PubMed 27759801Asahina M, Vichayanrat E, Low DA, Iodice V, Mathias CJ. Autonomic dysfunction in parkinsonian disorders: assessment and pathophysiology. J Neurol Neurosurg Psychiatry. 2013 Jun;84(6):674-80. doi: 10.1136/jnnp-2012-303135. Epub 2012 Sep 1.
PubMed 22942216Jain S, Goldstein DS. Cardiovascular dysautonomia in Parkinson disease: from pathophysiology to pathogenesis. Neurobiol Dis. 2012 Jun;46(3):572-80. doi: 10.1016/j.nbd.2011.10.025. Epub 2011 Nov 4.
PubMed 22094370Szili-Torok T, Kalman J, Paprika D, Dibo G, Rozsa Z, Rudas L. Depressed baroreflex sensitivity in patients with Alzheimer's and Parkinson's disease. Neurobiol Aging. 2001 May-Jun;22(3):435-8. doi: 10.1016/s0197-4580(01)00210-x.
PubMed 11378250Ziemssen T, Reichmann H. Treatment of dysautonomia in extrapyramidal disorders. Ther Adv Neurol Disord. 2010 Jan;3(1):53-67. doi: 10.1177/1756285609348902.
PubMed 21180636Pyatigorskaya N, Mongin M, Valabregue R, Yahia-Cherif L, Ewenczyk C, Poupon C, Debellemaniere E, Vidailhet M, Arnulf I, Lehericy S. Medulla oblongata damage and cardiac autonomic dysfunction in Parkinson disease. Neurology. 2016 Dec 13;87(24):2540-2545. doi: 10.1212/WNL.0000000000003426. Epub 2016 Nov 11.
PubMed 27837003Goldstein DS. Dysautonomia in Parkinson disease. Compr Physiol. 2014 Apr;4(2):805-26. doi: 10.1002/cphy.c130026.
PubMed 24715569Hohler AD, Zuzuarregui JR, Katz DI, Depiero TJ, Hehl CL, Leonard A, Allen V, Dentino J, Gardner M, Phenix H, Saint-Hilaire M, Ellis T. Differences in motor and cognitive function in patients with Parkinson's disease with and without orthostatic hypotension. Int J Neurosci. 2012 May;122(5):233-6. doi: 10.1080/00207454.2012.642038. Epub 2011 Dec 22.
PubMed 22191544Matinolli M, Korpelainen JT, Korpelainen R, Sotaniemi KA, Myllyla VV. Orthostatic hypotension, balance and falls in Parkinson's disease. Mov Disord. 2009 Apr 15;24(5):745-51. doi: 10.1002/mds.22457.
PubMed 19133666Sibley KM, Mochizuki G, Lakhani B, McIlroy WE. Autonomic contributions in postural control: a review of the evidence. Rev Neurosci. 2014;25(5):687-97. doi: 10.1515/revneuro-2014-0011.
PubMed 24854534Barbic F, Perego F, Canesi M, Gianni M, Biagiotti S, Costantino G, Pezzoli G, Porta A, Malliani A, Furlan R. Early abnormalities of vascular and cardiac autonomic control in Parkinson's disease without orthostatic hypotension. Hypertension. 2007 Jan;49(1):120-6. doi: 10.1161/01.HYP.0000250939.71343.7c. Epub 2006 Nov 13.
PubMed 17101845
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Effects of Automated Mechanical Peripheral Stimulation on Cardiovascular and Functional Variables in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04251728
- Acronym / sponsor ID
- 183/2018
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Católica del MauleUniversity, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 5 Feb 2020 (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.
This study evaluates the addition of automated mechanical peripheral stimulation (AMPS) to physical exercise in the treatment of cardiovascular and motor disabilities in Parkinson's patients. Half of participants will receive AMPS and exercise, while the other half will receive a simulated session (SHAM) and exercise.
Detailed description
Cardiovascular abnormalities are frequent in Parkinson's disease (PD) even in the early stages. As consequence, patients may experience orthostatic hypotension and/or arterial hypertension in the supine posture, especially at night. Thus, the management of dysautonomia in patients with PD is challenging.
Automated mechanical peripheral stimulation (AMPS) has been recently proposed as therapy for motor and cardiovascular improvements in patients with PD. On the other hand, physical exercise has been recommended for patients with PD showing to be effective in improving physical conditioning and cognitive function.
However, the combined effects of AMPS and exercise on cardiovascular variables and functional capacity of patients with PD are still unknown.
Therefore, volunteers will be randomly allocated into two groups: 1) exercise group: will be submitted to a program of 24 exercise sessions, along with 2 weekly sessions of SHAM AMPS for 12 weeks. 2) AMPS groups: will be submitted to the program of 24 exercise sessions, along with 2 weekly sessions of AMPS during the same period.
AMPS sessions will be held prior to exercise sessions. Before and after the 12-week program, all volunteers will be submitted to assessments of cardiac autonomic control, timed up and go, and cardiopulmonary exercise testing to assess aerobic functional capacity.
The hypothesis is that the exercise program combined with AMPS therapy will provide greater improvement on the cardiovascular function and aerobic functional capacity in patients with PD, than the exercise program alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-blind, two-arm, parallel-group study
| Arm | Type | Receives |
|---|---|---|
| Exercise plus AMPS group (AMPS-G) | Experimental | Device: Automated mechanical peripheral stimulation, Other: Physical ExercisePhysical exercise and automated mechanical peripheral stimulation (AMPS) with intensity at the pain threshold, performed two times a week for 12 weeks. |
| Exercise plus SHAM group (Exercise-G) | Sham comparator | Other: Physical Exercise, Device: SHAMPhysical exercise and simulated automated mechanical peripheral stimulation (AMPS) with intensity at the sensory threshold performed two times a week for 12 weeks. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of idiopathic Parkinson's disease
- Scoring 1 to 3 on the Hoehn and Yhar scale
- Pharmacological treatment unchanged for at least 30 days prior the study
Key exclusion criteria (4 listed)
- Signs of cognitive decline, based on the results of the Mini Mental State Examination
- Cardiorespiratory, neuromuscular and musculoskeletal diseases not related to PD
- Sensory peripheral neuropathy, diabetes or any other disease known to promote autonomic dysfunction
- Changes in pharmacological treatment after inclusion in the study
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 |
|---|---|---|
| Automated mechanical peripheral stimulationAlso: Mechanical somatosensory stimulation, GondolaAutomated mechanical pressure reaching the pain threshold in four specific points at the foots soles | Device | Exercise plus AMPS group (AMPS-G) |
| Physical ExerciseAlso: Exercise, Aerobic exerciseThe exercise program will be conducted for 12 weeks lasting 1 hour each session. Sessions will be held in groups and each session will comprise 4 steps: 1) Warm-up (5 min): patients will perform stretching of the main muscle groups of upper limbs, lower limbs and trunk; 2) Aerobic exercise (30 min): patients will perform continuous aerobic exercise consisting of walk on flat ground and ramps; 3) Resistance exercise training (20 min): volunteers will perform resistance exercises (2 sets x 15 repetitions) for upper and lower limbs, and trunk working the following muscle groups: shoulder flexors, extensors and abductors; elbow flexors and extensors; trunk extensors and flexors; knee flexors and extensors; and dorsiflexors and plantar flexors; 4) Cool-down (5 min): Stretching of the main muscle groups worked during the sessions and relaxation. | Other | Exercise plus AMPS group (AMPS-G), Exercise plus SHAM group (Exercise-G) |
| SHAMAutomated mechanical pressure reaching the sensory threshold in four specific points at the foots soles | Device | Exercise plus SHAM group (Exercise-G) |
Primary outcome
Short Physical Performance Battery (SPPB)
Time frame: 12 weeks
This standardized test evaluates the physical function of the lower extremities in older adults. It includes three parts: a standing balance test, a 4-meter gait speed assessment, and a chair stand test involving five consecutive sit-to-stand actions. Each part is rated on a scale from 0 (unable to perform) to 4 (optimal performance), resulting in a total score between 0 and 12 points. Higher scores indicate better physical performance, whereas lower scores indicate functional limitations.
Peak oxygen uptake
Time frame: 12 weeks
An incremental ramp-type protocol exercise will be used to determine the participant's aerobic capacity. Oxygen uptake will be obtained on a breath-to-breath basis during the entire exercise using an expired gas measurement system.
Parkinson's Disease Questionnaire 39 (PDQ-39)
Time frame: 12 weeks
This questionnaire is a disease-specific tool crafted to evaluate the health-related quality of life in individuals with PD. It comprises 39 items divided into eight dimensions: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Each item is rated on a five-point scale ranging from 0 (never) to 4 (always). Domain scores are then converted to a scale from 0 to 100, where higher scores signify a greater impact of the disease and, consequently, a poorer quality of life.
Unified Parkinson's Disease Rating Scale Part III (UPDRS III)
Time frame: 12 weeks
It is the most widely applied rating instrument for measured motor symptoms in PD. Motor examination, including 18 items Some of them are for each of the upper and lower extremities, neck or jaw, and are scored according to severity from 0 (normal) to 4 (severe), which gives a final score that can vary between 0 to 132 points.
Heart rate variability
Time frame: 12 weeks
Quantification of heart rate oscillation to assess the cardiac autonomic control. This is quantified by time-domain, spectral and non-linear analysis.
4 secondary outcomes
Freezing of Gait Questionnaire (FOG-Q)
Time frame: 12 weeks
Timed up and go
Time frame: 12 weeks
4-meter gait speed test (4mGT)
Time frame: 12 weeks
5 times sit-to-stand test (5XSST)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Background[1] Souza CFM, Almeida HCP, Souza JB, Costa PH, Silveira YSS, Bezerra JCL. A doença de Parkinson e o processo de envelhecimento motor: uma revisão da literatura. Revista de Neurociências, 2011. 19(4): p. 6.
- Background: PubMed 16482566Barbosa MT, Caramelli P, Maia DP, Cunningham MC, Guerra HL, Lima-Costa MF, Cardoso F. Parkinsonism and Parkinson's disease in the elderly: a community-based survey in Brazil (the Bambui study). Mov Disord. 2006 Jun;21(6):800-8. doi: 10.1002/mds.20806.
- Background: PubMed 23900323Chana C P, Jimenez C M, Diaz T V, Juri C. [Parkinson disease mortality rates in Chile]. Rev Med Chil. 2013 Mar;141(3):327-31. doi: 10.4067/S0034-98872013000300007. Spanish.
- BackgroundRosa JdC, Cielo CA, Cechella C. Função fonatória em pacientes com doença de Parkinson: uso de instrumento de sopro. Revista CEFAC, 2009. 11: p. 305-313.
- Background: PubMed 27759801Teive HA, Bertucci DC Filho, Munhoz RP. Unusual motor and non-motor symptoms and signs in the early stage of Parkinson's disease. Arq Neuropsiquiatr. 2016 Oct;74(10):781-784. doi: 10.1590/0004-282X20160126.
- Background: PubMed 22942216Asahina M, Vichayanrat E, Low DA, Iodice V, Mathias CJ. Autonomic dysfunction in parkinsonian disorders: assessment and pathophysiology. J Neurol Neurosurg Psychiatry. 2013 Jun;84(6):674-80. doi: 10.1136/jnnp-2012-303135. Epub 2012 Sep 1.
- Background: PubMed 22094370Jain S, Goldstein DS. Cardiovascular dysautonomia in Parkinson disease: from pathophysiology to pathogenesis. Neurobiol Dis. 2012 Jun;46(3):572-80. doi: 10.1016/j.nbd.2011.10.025. Epub 2011 Nov 4.
- Background: PubMed 11378250Szili-Torok T, Kalman J, Paprika D, Dibo G, Rozsa Z, Rudas L. Depressed baroreflex sensitivity in patients with Alzheimer's and Parkinson's disease. Neurobiol Aging. 2001 May-Jun;22(3):435-8. doi: 10.1016/s0197-4580(01)00210-x.
- Background: PubMed 21180636Ziemssen T, Reichmann H. Treatment of dysautonomia in extrapyramidal disorders. Ther Adv Neurol Disord. 2010 Jan;3(1):53-67. doi: 10.1177/1756285609348902.
- Background: PubMed 27837003Pyatigorskaya N, Mongin M, Valabregue R, Yahia-Cherif L, Ewenczyk C, Poupon C, Debellemaniere E, Vidailhet M, Arnulf I, Lehericy S. Medulla oblongata damage and cardiac autonomic dysfunction in Parkinson disease. Neurology. 2016 Dec 13;87(24):2540-2545. doi: 10.1212/WNL.0000000000003426. Epub 2016 Nov 11.
- Background: PubMed 24715569Goldstein DS. Dysautonomia in Parkinson disease. Compr Physiol. 2014 Apr;4(2):805-26. doi: 10.1002/cphy.c130026.
- Background: PubMed 22191544Hohler AD, Zuzuarregui JR, Katz DI, Depiero TJ, Hehl CL, Leonard A, Allen V, Dentino J, Gardner M, Phenix H, Saint-Hilaire M, Ellis T. Differences in motor and cognitive function in patients with Parkinson's disease with and without orthostatic hypotension. Int J Neurosci. 2012 May;122(5):233-6. doi: 10.1080/00207454.2012.642038. Epub 2011 Dec 22.
- Individual participant dataSharing planned: No. Participant data will be shared upon request at the end of the study.
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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.
Antonio R Zamunér, PhD principal investigator
Universidad Católica del Maule
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated mechanical peripheral stimulation and Physical Exercise in people with Parkinson Disease, run by Universidad Católica del Maule at 1 site in Chile.
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 4 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: finished, as of the sponsor's last update on 24 Mar 2026. 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 Chile. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (SPPB) (time frame: 12 weeks). The study lists 5 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 NCT04251728, which also lists 32 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 24 Mar 2026.