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

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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

Tracking Information
First Submitted Date  ICMJE January 30, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date September 1, 2020
Actual Study Start Date  ICMJE March 2, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
  • 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
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • 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
  • Heart rate variability [ Time Frame: 12 weeks ]
    Quantification of RR intervals oscillation of an electrocardiogram. This is quantified by time-domain, spectral and non-linear analysis.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of AMPS on Cardiovascular Variables in Patients With Parkinson's Disease
Official Title  ICMJE Acute and Chronic Effects of Automated Mechanical Peripheral Stimulation on Cardiovascular Variables in Patients With Parkinson's Disease
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • 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
  • Device: SHAM
    Automated mechanical pressure reaching the sensory threshold in four specific points at the foots soles
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Automated mechanical peripheral stimulation
    • Other: Physical 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.
    Interventions:
    • Other: Physical Exercise
    • Device: SHAM
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2021
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04251728
Other Study ID Numbers  ICMJE 183/2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Participant data will be shared upon request at the end of the study.
Responsible Party Antonio Roberto Zamunér, Universidad Católica del Maule
Study Sponsor  ICMJE Universidad Católica del Maule
Collaborators  ICMJE Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Investigators  ICMJE
Principal Investigator: Antonio R Zamunér, PhD Universidad Católica del Maule
PRS Account Universidad Católica del Maule
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP