Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fondo Nacional de Desarrollo CientÃfico y Tecnológico, Chile | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise plus AMPS group (AMPS-G) | Experimental | Physical exercise and automated mechanical peripheral stimulation (AMPS) with intensity at the pain threshold, performed two times a week for 12 weeks. |
|
| Exercise plus SHAM group (Exercise-G) | Sham Comparator | Physical exercise and simulated automated mechanical peripheral stimulation (AMPS) with intensity at the sensory threshold performed two times a week for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated mechanical peripheral stimulation | Device | Automated mechanical pressure reaching the pain threshold in four specific points at the foots soles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Short Physical Performance Battery (SPPB) | This standardized test evaluates the physical function of the lower extremities in older adults. It includes three parts: a standing balance test, a 4-meter gait speed assessment, and a chair stand test involving five consecutive sit-to-stand actions. Each part is rated on a scale from 0 (unable to perform) to 4 (optimal performance), resulting in a total score between 0 and 12 points. Higher scores indicate better physical performance, whereas lower scores indicate functional limitations. | 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 |
| Parkinson's Disease Questionnaire 39 (PDQ-39) | This questionnaire is a disease-specific tool crafted to evaluate the health-related quality of life in individuals with PD. It comprises 39 items divided into eight dimensions: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Each item is rated on a five-point scale ranging from 0 (never) to 4 (always). Domain scores are then converted to a scale from 0 to 100, where higher scores signify a greater impact of the disease and, consequently, a poorer quality of life. | 12 weeks |
| Unified Parkinson's Disease Rating Scale Part III (UPDRS III) | It is the most widely applied rating instrument for measured motor symptoms in PD. Motor examination, including 18 items Some of them are for each of the upper and lower extremities, neck or jaw, and are scored according to severity from 0 (normal) to 4 (severe), which gives a final score that can vary between 0 to 132 points. | 12 weeks |
| Heart rate variability |
| Measure | Description | Time Frame |
|---|---|---|
| Freezing of Gait Questionnaire (FOG-Q) | It is the only validated tool for the assessment of FOG severity in people with PD. FOG-Q total score ranges from 0 to 24 points and higher scores correspond to more severe FOG. | 12 weeks |
| Timed up and go |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Antonio R Zamunér, PhD | Universidad Católica del Maule | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Católica del Maule | Talca | Maule Region | 3469001 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | [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. | ||
| 16482566 | Background | Barbosa MT, Caramelli P, Maia DP, Cunningham MC, Guerra HL, Lima-Costa MF, Cardoso F. Parkinsonism and Parkinson's disease in the elderly: a community-based survey in Brazil (the Bambui study). Mov Disord. 2006 Jun;21(6):800-8. doi: 10.1002/mds.20806. | |
| 23900323 |
Not provided
Not provided
Participant data will be shared upon request at the end of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
A randomized, double-blind, two-arm, parallel-group study
Not provided
Not provided
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.
|
| Physical Exercise | Other | 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 | Device | Automated mechanical pressure reaching the sensory threshold in four specific points at the foots soles |
|
Quantification of heart rate oscillation to assess the cardiac autonomic control. This is quantified by time-domain, spectral and non-linear analysis. |
| 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
| 12 weeks |
| 4-meter gait speed test (4mGT) | It is being used increasingly as both a stand-alone measure and as a component of the SPPB, and it is a reliable option to measure gait speed for older adults. The test was conducted in an unobstructed corridor measuring 8 meters in length. Two markers were positioned on the floor at the 2-meter and 6-meter points, thereby establishing a central walking distance of 4 meters. Participants were instructed to begin by standing with both feet behind the starting line and, upon the command "Go," to proceed at their usual, comfortable pace until they crossed the finish line. The time required to traverse the central 4 meters was recorded using a stopwatch. Gait speed was measured in seconds (s). | 12 weeks |
| 5 times sit-to-stand test (5XSST) | Repeated performance of sit-to-stand has often been used as a measure of lower extremity strength in older people. It is also validated for people with PD with a sensitivity of 75%, and a specificity of 68%. The participants completed five repetitions of sit-to-stand from a standard chair (height: 0.49m) as quickly as possible upon hearing the cue "Ready, set, go!", measured in seconds. | 12 weeks |
| Background |
| Chana C P, Jimenez C M, Diaz T V, Juri C. [Parkinson disease mortality rates in Chile]. Rev Med Chil. 2013 Mar;141(3):327-31. doi: 10.4067/S0034-98872013000300007. Spanish. |
| Background | 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. |
| 27759801 | Background | Teive HA, Bertucci DC Filho, Munhoz RP. Unusual motor and non-motor symptoms and signs in the early stage of Parkinson's disease. Arq Neuropsiquiatr. 2016 Oct;74(10):781-784. doi: 10.1590/0004-282X20160126. |
| 22942216 | Background | Asahina M, Vichayanrat E, Low DA, Iodice V, Mathias CJ. Autonomic dysfunction in parkinsonian disorders: assessment and pathophysiology. J Neurol Neurosurg Psychiatry. 2013 Jun;84(6):674-80. doi: 10.1136/jnnp-2012-303135. Epub 2012 Sep 1. |
| 22094370 | Background | Jain S, Goldstein DS. Cardiovascular dysautonomia in Parkinson disease: from pathophysiology to pathogenesis. Neurobiol Dis. 2012 Jun;46(3):572-80. doi: 10.1016/j.nbd.2011.10.025. Epub 2011 Nov 4. |
| 11378250 | Background | Szili-Torok T, Kalman J, Paprika D, Dibo G, Rozsa Z, Rudas L. Depressed baroreflex sensitivity in patients with Alzheimer's and Parkinson's disease. Neurobiol Aging. 2001 May-Jun;22(3):435-8. doi: 10.1016/s0197-4580(01)00210-x. |
| 21180636 | Background | Ziemssen T, Reichmann H. Treatment of dysautonomia in extrapyramidal disorders. Ther Adv Neurol Disord. 2010 Jan;3(1):53-67. doi: 10.1177/1756285609348902. |
| 27837003 | Background | Pyatigorskaya N, Mongin M, Valabregue R, Yahia-Cherif L, Ewenczyk C, Poupon C, Debellemaniere E, Vidailhet M, Arnulf I, Lehericy S. Medulla oblongata damage and cardiac autonomic dysfunction in Parkinson disease. Neurology. 2016 Dec 13;87(24):2540-2545. doi: 10.1212/WNL.0000000000003426. Epub 2016 Nov 11. |
| 24715569 | Background | Goldstein DS. Dysautonomia in Parkinson disease. Compr Physiol. 2014 Apr;4(2):805-26. doi: 10.1002/cphy.c130026. |
| 22191544 | Background | Hohler AD, Zuzuarregui JR, Katz DI, Depiero TJ, Hehl CL, Leonard A, Allen V, Dentino J, Gardner M, Phenix H, Saint-Hilaire M, Ellis T. Differences in motor and cognitive function in patients with Parkinson's disease with and without orthostatic hypotension. Int J Neurosci. 2012 May;122(5):233-6. doi: 10.1080/00207454.2012.642038. Epub 2011 Dec 22. |
| 19133666 | Background | Matinolli M, Korpelainen JT, Korpelainen R, Sotaniemi KA, Myllyla VV. Orthostatic hypotension, balance and falls in Parkinson's disease. Mov Disord. 2009 Apr 15;24(5):745-51. doi: 10.1002/mds.22457. |
| 24854534 | Background | Sibley KM, Mochizuki G, Lakhani B, McIlroy WE. Autonomic contributions in postural control: a review of the evidence. Rev Neurosci. 2014;25(5):687-97. doi: 10.1515/revneuro-2014-0011. |
| 17101845 | Background | Barbic F, Perego F, Canesi M, Gianni M, Biagiotti S, Costantino G, Pezzoli G, Porta A, Malliani A, Furlan R. Early abnormalities of vascular and cardiac autonomic control in Parkinson's disease without orthostatic hypotension. Hypertension. 2007 Jan;49(1):120-6. doi: 10.1161/01.HYP.0000250939.71343.7c. Epub 2006 Nov 13. |
| 19768301 | Background | Vanderlei LC, Pastre CM, Hoshi RA, Carvalho TD, Godoy MF. Basic notions of heart rate variability and its clinical applicability. Rev Bras Cir Cardiovasc. 2009 Apr-Jun;24(2):205-17. doi: 10.1590/s0102-76382009000200018. |
| 23370966 | Background | Hillebrand S, Gast KB, de Mutsert R, Swenne CA, Jukema JW, Middeldorp S, Rosendaal FR, Dekkers OM. Heart rate variability and first cardiovascular event in populations without known cardiovascular disease: meta-analysis and dose-response meta-regression. Europace. 2013 May;15(5):742-9. doi: 10.1093/europace/eus341. Epub 2013 Jan 30. |
| 11136353 | Background | Kallio M, Haapaniemi T, Turkka J, Suominen K, Tolonen U, Sotaniemi K, Heikkila VP, Myllyla V. Heart rate variability in patients with untreated Parkinson's disease. Eur J Neurol. 2000 Nov;7(6):667-72. doi: 10.1046/j.1468-1331.2000.00127.x. |
| 21674624 | Background | Allen NE, Sherrington C, Paul SS, Canning CG. Balance and falls in Parkinson's disease: a meta-analysis of the effect of exercise and motor training. Mov Disord. 2011 Aug 1;26(9):1605-15. doi: 10.1002/mds.23790. Epub 2011 Jun 14. |
| 27467253 | Background | Peek AL, Stevens ML. Resistance training for people with Parkinson's disease (PEDro synthesis). Br J Sports Med. 2016 Sep;50(18):1158. doi: 10.1136/bjsports-2016-096311. Epub 2016 May 13. No abstract available. |
| 22822237 | Background | Schenkman M, Hall DA, Baron AE, Schwartz RS, Mettler P, Kohrt WM. Exercise for people in early- or mid-stage Parkinson disease: a 16-month randomized controlled trial. Phys Ther. 2012 Nov;92(11):1395-410. doi: 10.2522/ptj.20110472. Epub 2012 Jul 19. |
| 24659140 | Background | Ganesan M, Pal PK, Gupta A, Sathyaprabha TN. Treadmill gait training improves baroreflex sensitivity in Parkinson's disease. Clin Auton Res. 2014 Jun;24(3):111-8. doi: 10.1007/s10286-014-0236-z. |
| 24436294 | Background | Barbic F, Galli M, Dalla Vecchia L, Canesi M, Cimolin V, Porta A, Bari V, Cerri G, Dipaola F, Bassani T, Cozzolino D, Pezzoli G, Furlan R. Effects of mechanical stimulation of the feet on gait and cardiovascular autonomic control in Parkinson's disease. J Appl Physiol (1985). 2014 Mar 1;116(5):495-503. doi: 10.1152/japplphysiol.01160.2013. Epub 2014 Jan 16. |
| 26164797 | Background | Stocchi F, Sale P, Kleiner AF, Casali M, Cimolin V, de Pandis F, Albertini G, Galli M. Long-term effects of automated mechanical peripheral stimulation on gait patterns of patients with Parkinson's disease. Int J Rehabil Res. 2015 Sep;38(3):238-45. doi: 10.1097/MRR.0000000000000120. |
| 23720648 | Background | Stuebner E, Vichayanrat E, Low DA, Mathias CJ, Isenmann S, Haensch CA. Twenty-four hour non-invasive ambulatory blood pressure and heart rate monitoring in Parkinson's disease. Front Neurol. 2013 May 15;4:49. doi: 10.3389/fneur.2013.00049. eCollection 2013. |
| 25690741 | Background | Stuebner E, Vichayanrat E, Low DA, Mathias CJ, Isenmann S, Haensch CA. Non-dipping nocturnal blood pressure and psychosis parameters in Parkinson disease. Clin Auton Res. 2015 Apr;25(2):109-16. doi: 10.1007/s10286-015-0270-5. Epub 2015 Feb 18. |
| 26495152 | Background | Kleiner A, Galli M, Gaglione M, Hildebrand D, Sale P, Albertini G, Stocchi F, De Pandis MF. The Parkinsonian Gait Spatiotemporal Parameters Quantified by a Single Inertial Sensor before and after Automated Mechanical Peripheral Stimulation Treatment. Parkinsons Dis. 2015;2015:390512. doi: 10.1155/2015/390512. Epub 2015 Oct 1. |
| 6067254 | Background | Hoehn MM, Yahr MD. Parkinsonism: onset, progression and mortality. Neurology. 1967 May;17(5):427-42. doi: 10.1212/wnl.17.5.427. No abstract available. |
| 9923759 | Background | Gelb DJ, Oliver E, Gilman S. Diagnostic criteria for Parkinson disease. Arch Neurol. 1999 Jan;56(1):33-9. doi: 10.1001/archneur.56.1.33. |
| 23292821 | Background | Palmerini L, Mellone S, Avanzolini G, Valzania F, Chiari L. Quantification of motor impairment in Parkinson's disease using an instrumented timed up and go test. IEEE Trans Neural Syst Rehabil Eng. 2013 Jul;21(4):664-73. doi: 10.1109/TNSRE.2012.2236577. Epub 2013 Jan 1. |
| 23128427 | Background | Shulman LM, Katzel LI, Ivey FM, Sorkin JD, Favors K, Anderson KE, Smith BA, Reich SG, Weiner WJ, Macko RF. Randomized clinical trial of 3 types of physical exercise for patients with Parkinson disease. JAMA Neurol. 2013 Feb;70(2):183-90. doi: 10.1001/jamaneurol.2013.646. |
| 33823928 | Derived | 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |