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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251728
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : September 1, 2020
Sponsor:
Collaborator:
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Information provided by (Responsible Party):
Antonio Roberto Zamunér, Universidad Católica del Maule

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Automated mechanical peripheral stimulation Other: Physical Exercise Device: SHAM Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, double-blind, two-arm, parallel-group study
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Acute and Chronic Effects of Automated Mechanical Peripheral Stimulation on Cardiovascular Variables in Patients With Parkinson's Disease
Actual Study Start Date : March 2, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


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.
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

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




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Oxygen uptake at the ventilatory anaerobic threshold [ Time Frame: 12 weeks ]
    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.

  2. 24-h blood pressure [ Time Frame: 12 weeks ]
    Evaluation of systolic and diastolic blood pressure during 24 hours will be recorded using an ambulatory blood pressure holter.

  3. Sleep quality [ Time Frame: 12 weeks ]
    Sleep quality will be assessed using an actigraph monitor by quantifying the sleep onset, sleep latency, sleep duration, sleep efficiency and sleep disturbances.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251728


Contacts
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Contact: Antonio R Zamunér, PhD +56 71 241 3640 ext 1640 azamuner@ucm.cl
Contact: Nicolle Zelada, PE +56 9 6742 6473 zeladanicolle@gmail.com

Locations
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Chile
Universidad Católica del Maule Recruiting
Talca, Maule, Chile, 3469001
Contact: Nicolle Zelada, PE    +56 9 6742 6473    zeladanicolle@gmail.com   
Contact: Antonio R Zamunér, PhD    +56 71 241 3640 ext 1640    azamuner@ucm.cl   
Sponsors and Collaborators
Universidad Católica del Maule
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Investigators
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Principal Investigator: Antonio R Zamunér, PhD Universidad Católica del Maule
Publications:
[1] Souza CFM, Almeida HCP, Souza JB, Costa PH, Silveira YSS, Bezerra JCL. A doença de Parkinson e o processo de envelhecimento motor: uma revisão da literatura. Revista de Neurociências, 2011. 19(4): p. 6.
Rosa JdC, Cielo CA, Cechella C. Função fonatória em pacientes com doença de Parkinson: uso de instrumento de sopro. Revista CEFAC, 2009. 11: p. 305-313.

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Responsible Party: Antonio Roberto Zamunér, Adjunct Professor - Principal Investigator, Universidad Católica del Maule
ClinicalTrials.gov Identifier: NCT04251728    
Other Study ID Numbers: 183/2018
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participant data will be shared upon request at the end of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases