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Acute and Chronic Effects of Automated Mechanical Peripheral Stimulation on Cardiovascular 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.
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.
Age
30 - 90 years
Sex
ALL
Healthy Volunteers
No
Universidad Católica del Maule
Talca, Maule Region, Chile
Start Date
July 30, 2021
Primary Completion Date
April 30, 2023
Completion Date
April 30, 2023
Last Updated
April 16, 2024
40
ACTUAL participants
Automated mechanical peripheral stimulation
DEVICE
Physical Exercise
OTHER
SHAM
DEVICE
Lead Sponsor
Universidad Católica del Maule
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06113640