Chronic Effects of Automated Mechanical Peripheral Stimulation on Cardiovascular and Functional Variables in Patients With Parkinson's Disease
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Parkinson Disease
- 发起方
- Universidad Católica del Maule
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Heart rate variability
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
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.
详细描述
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.
研究者
Antonio Roberto Zamunér
Adjunct Professor - Principal Investigator
Universidad Católica del Maule
入排标准
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Heart rate variability
时间窗: 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
时间窗: 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.
Short Physical Performance Battery (SPPB)
时间窗: 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.
Parkinson's Disease Questionnaire 39 (PDQ-39)
时间窗: 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)
时间窗: 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.
次要结局
- Freezing of Gait Questionnaire (FOG-Q)(12 weeks)
- Timed up and go(12 weeks)
- 4-meter gait speed test (4mGT)(12 weeks)
- 5 times sit-to-stand test (5XSST)(12 weeks)