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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acute and Chronic Effects of Automated Mechanical Peripheral Stimulation on Cardiovascular Variables in Patients With Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Automated mechanical peripheral stimulation
* Other: Physical Exercise
* Device: SHAM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, double-blind, two-arm, parallel-group study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise plus AMPS group (AMPS-G)<br>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<br>* Automated mechanical pressure reaching the pain threshold in four specific points at the foots soles<br>* Other names: Gondola;Other: Physical Exercise<br>* 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.<br>* Other names: Aerobic exercise;|
| Sham Comparator: Exercise plus SHAM group (Exercise-G)<br>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<br>* 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.<br>* Other names: Aerobic exercise;Device: SHAM<br>* Automated mechanical pressure reaching the sensory threshold in four specific points at the foots soles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen uptake at the ventilatory anaerobic threshold | The ventilatory anaerobic threshold will be determined from the recording of oxygen uptake and carbon dioxide production measurement during an incremental ramp-type protocol exercise using an expired gas measurement system. | 12 weeks | 
| 24-h blood pressure | Evaluation of systolic and diastolic blood pressure during 24 hours will be recorded using an ambulatory blood pressure holter. | 12 weeks | 
| Sleep quality | Sleep quality will be assessed using an actigraph monitor by quantifying the sleep onset, sleep latency, sleep duration, sleep efficiency and sleep disturbances. | 12 weeks |