Parkinson Disease
Conditions
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.
Interventions
Automated mechanical pressure reaching the pain threshold in four specific points at the foots soles
OTHERPhysical 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.
DEVICESHAM
Automated mechanical pressure reaching the sensory threshold in four specific points at the foots soles
Sponsors
Universidad Católica del Maule
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Intervention model description
A randomized, double-blind, two-arm, parallel-group study
Eligibility
Sex/Gender
ALL
Age
30 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Physical Performance Battery (SPPB) | 12 weeks | 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. |
| Peak oxygen uptake | 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. |
| Parkinson's Disease Questionnaire 39 (PDQ-39) | 12 weeks | 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. |
| Unified Parkinson's Disease Rating Scale Part III (UPDRS III) | 12 weeks | 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. |
| Heart rate variability | 12 weeks | Quantification of heart rate oscillation to assess the cardiac autonomic control. This is quantified by time-domain, spectral and non-linear analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freezing of Gait Questionnaire (FOG-Q) | 12 weeks | 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. |
| Timed up and go | 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 |
| 4-meter gait speed test (4mGT) | 12 weeks | 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). |
| 5 times sit-to-stand test (5XSST) | 12 weeks | 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. |
Countries
Chile
Contacts
PRINCIPAL_INVESTIGATORAntonio R Zamunér, PhD
Universidad Católica del Maule
Outcome results
None listed