Effects of AMPS on Cardiovascular Variables in Patients With Parkinson's Disease
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| ClinicalTrials.gov Identifier: NCT04251728 |
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Recruitment Status :
Recruiting
First Posted : February 5, 2020
Last Update Posted : September 1, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson Disease | Device: Automated mechanical peripheral stimulation Other: Physical Exercise Device: SHAM | Not Applicable |
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 : | 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Device: Automated mechanical peripheral stimulation
Automated mechanical pressure reaching the pain threshold in four specific points at the foots soles
Other Names:
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:
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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.
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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:
Device: SHAM Automated mechanical pressure reaching the sensory threshold in four specific points at the foots soles |
- 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.
- 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.
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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 |
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
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
| 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 |
| 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 | |
| Principal Investigator: | Antonio R Zamunér, PhD | Universidad Católica del Maule |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |