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

Universidad Católica del Maule

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: SHAM; Device: Automated mechanical peripheral stimulation; Other: Physical Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04251728

183/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Exercise plus AMPS group (AMPS-G)

Experimental group

Description:

Physical exercise and automated mechanical peripheral stimulation (AMPS) with intensity at the pain threshold, performed two times a week for 12 weeks.

Treatment:

Other: Physical Exercise

Device: Automated mechanical peripheral stimulation

Exercise plus SHAM group (Exercise-G)

Sham Comparator group

Description:

Physical exercise and simulated automated mechanical peripheral stimulation (AMPS) with intensity at the sensory threshold performed two times a week for 12 weeks.

Treatment:

Other: Physical Exercise

Device: SHAM