Effects of AMPS on Cardiovascular Variables in Patients With Parkinson's Disease
NCT ID: NCT04251728
Last Updated: 2024-04-16
Study Results
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Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2021-07-30
2023-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
The outcomes assessor will be in charge only of the evaluations with no information about the group participants belong to.
Study Groups
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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.
Automated mechanical peripheral stimulation
Automated mechanical pressure reaching the pain threshold in four specific points at the foots soles
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.
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.
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.
SHAM
Automated mechanical pressure reaching the sensory threshold in four specific points at the foots soles
Interventions
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Automated mechanical peripheral stimulation
Automated mechanical pressure reaching the pain threshold in four specific points at the foots soles
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.
SHAM
Automated mechanical pressure reaching the sensory threshold in four specific points at the foots soles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scoring 1 to 3 on the Hoehn and Yhar scale
* Pharmacological treatment unchanged for at least 30 days prior the study
Exclusion Criteria
* 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
30 Years
90 Years
ALL
No
Sponsors
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Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
OTHER_GOV
Universidad Católica del Maule
OTHER
Responsible Party
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Antonio Roberto Zamunér
Adjunct Professor - Principal Investigator
Principal Investigators
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Antonio R Zamunér, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad Católica del Maule
Locations
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Universidad Católica del Maule
Talca, Maule Region, Chile
Countries
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References
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Zelada-Astudillo N, Moreno VC, Herrera-Santelices A, Barbieri FA, Zamuner AR. Effect of the combination of automated peripheral mechanical stimulation and physical exercise on aerobic functional capacity and cardiac autonomic control in patients with Parkinson's disease: a randomized clinical trial protocol. Trials. 2021 Apr 6;22(1):250. doi: 10.1186/s13063-021-05177-w.
Other Identifiers
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183/2018
Identifier Type: -
Identifier Source: org_study_id
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