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

NCT04251728 | Completed

• 1 other identifier: 183/2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  12 weeks

Secondary Outcomes (4)

• Freezing of Gait Questionnaire (FOG-Q)

  12 weeks

• Timed up and go

  12 weeks

• 4-meter gait speed test (4mGT)

  12 weeks

• 5 times sit-to-stand test (5XSST)

  12 weeks

Study Arms (2)

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.

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.

Other: Physical Exercise; Device: SHAM

Interventions

Automated mechanical peripheral stimulation DEVICE

Automated mechanical pressure reaching the pain threshold in four specific points at the foots soles

Also known as: Mechanical somatosensory stimulation, Gondola

Exercise plus AMPS group (AMPS-G)

Physical Exercise OTHER

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.

Also known as: Exercise, Aerobic exercise

Exercise plus AMPS group (AMPS-G); Exercise plus SHAM group (Exercise-G)

SHAM DEVICE

Automated mechanical pressure reaching the sensory threshold in four specific points at the foots soles

Exercise plus SHAM group (Exercise-G)

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Católica del Maule: lead
• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile: collaborator

Study Sites (1)

Universidad Católica del Maule

Talca, Maule Region, 3469001, Chile

Location

Related Publications (32)

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  BACKGROUND

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  PMID: 33823928 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Antonio R Zamunér, PhD

  Universidad Católica del Maule

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be assigned to Exercise plus AMPS group or Exercise plus Placebo. The placebo consist in replicating the same experimental setting and procedure, but the intensity of the stimulus is not sufficient to elicit an effect. The outcomes assessor will be in charge only of the evaluations with no information about the group participants belong to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor - Principal Investigator

Model Details: A randomized, double-blind, two-arm, parallel-group study

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: March 30, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)