Effects of AMPS on Cardiovascular and Functional Variables in Patients With Parkinson's Disease

March 19, 2026 updated by: Antonio Roberto Zamunér, Universidad Católica del Maule

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Maule Region
      • Talca, Maule Region, Chile, 3469001
        • Universidad Católica del Maule

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise plus AMPS group (AMPS-G)
Physical exercise and automated mechanical peripheral stimulation (AMPS) with intensity at the pain threshold, performed two times a week for 12 weeks.
Device: Automated mechanical peripheral stimulation
Automated mechanical pressure reaching the pain threshold in four specific points at the foots soles
Other Names:
  • Mechanical somatosensory stimulation
  • Gondola
Other: Physical 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.
Other Names:
  • Exercise
  • Aerobic exercise
Sham Comparator: Exercise plus SHAM group (Exercise-G)
Physical exercise and simulated automated mechanical peripheral stimulation (AMPS) with intensity at the sensory threshold performed two times a week for 12 weeks.
Device: SHAM
Automated mechanical pressure reaching the sensory threshold in four specific points at the foots soles
Other: Physical 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.
Other Names:
  • Exercise
  • Aerobic exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed up and go
Time Frame: 12 weeks
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
12 weeks
Freezing of Gait Questionnaire (FOG-Q)
Time Frame: 12 weeks
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.
12 weeks
4-meter gait speed test (4mGT)
Time Frame: 12 weeks
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).
12 weeks
5 times sit-to-stand test (5XSST)
Time Frame: 12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Católica del Maule

Collaborators

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Investigators

  • Principal Investigator: Antonio R Zamunér, PhD, Universidad Católica del Maule

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2022

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

January 30, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 183/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participant data will be shared upon request at the end of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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