The Chronic Effect of Ischemic Conditioning on Motor Function, Cognitive Performance, and Immune System in Individuals With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
- 主要终点
- Unified Parkinson's Disease Rating Scale
研究概览
简要总结
Ischemic conditioning (IC) is a promising therapy that can mimic the physiological effects of physical exercise. IC consists of using a cuff to measure blood pressure and calibrate 200 mmHg on the upper or lower limb. Thus, at alternating intervals of 5 minutes, ischemia or reperfusion occurs, depending on whether the cuff is inflated or deflated. IC induces changes in spinal cord excitability for the last reflex reactions of recruited motoneurons with improved balance control in healthy young people and improved learning in the elderly. The objective of the present study is to evaluate the chronic effect of IC on the motor function and cognitive performance of patients with Parkinson's disease. Furthermore, the investigators will evaluate secondary outcomes such as mobility, quality of life, and immunological responses.
详细描述
Parkinson's disease (PD) is a neurodegenerative disorder that causes a variety of motor and non-motor symptoms. Typically, patients with PD suffer from disabilities and secondary complications even when the disease is optimally treated, and many patients still have sedentary lifestyles, which in turn result in higher rates of mortality and comorbidity. Physical activity is an essential element in maintaining daily functional capabilities and quality of life. However, patients with PD have motor and non-motor deficits that can prevent or limit physical exercise, such as running or resistance exercise. Ischemic conditioning (IC) is a promising therapy that can mimic the physiological effects of physical exercise. IC consists of using a cuff to measure blood pressure, calibrated between 180 and 200 mmHg on the upper or lower limb. Thus, at alternating intervals of 5 minutes, ischemia or reperfusion occurs, depending on whether the cuff is inflated or deflated. IC induces changes in spinal cord excitability for the last reflex reactions of recruited motoneurons with improved balance control in healthy young people and improved learning in the elderly. Recently, IC has been shown to improve cognitive performance in neurological patients with stroke, subcortical ischemia, and vascular dementia. However, there are no studies that have evaluated the effect of IC on motor and cognitive performance in patients with PD. The objective of the present study is to evaluate the chronic effect of IC on the motor and cognitive performance of patients with PD. Furthermore, the investigators intend to evaluate other secondary outcomes such as mobility, quality of life, and immunological responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be blinded to treatment allocation, constituting the prespecified double-blind design. In addition, the principal investigator, treating physical educator, laboratory personnel processing and analysing biological samples, and data analysts will remain blinded whenever technically feasible. Masking will be supported by use of the same device and cuffs, identical session duration and cycle structure, standardized instructions and staff contact, concealed pressure displays, and neutral coded programs prepared by an independent unblinded trial coordinator.
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PD patients aged 40 years or older;
- •Diagnosis of PD without cognitive complaints or with complaints, but without impact on daily activities;
排除标准
- •Patients with uncontrolled diabetes mellitus or peripheral neuropathy;
- •Uncontrolled arterial hypertension (BP>160/100mmHg);
- •Uncontrolled diabetes (Fasting glucose > 250mg/dl, peripheral retinopathy or diabetic ketoacidosis);
- •Uncontrolled dyslipidemia (total chol > 220mg/dL);
- •Pre-existing autoimmune diseases;
- •Infectious conditions for less than 1 month;
- •Neurological problems that prevent training from being carried out;
- •History of anemia, cerebral vascular disease, myocardial infarction in the last 6 months;
- •Previous deep vein thrombosis;
- •Smoking < 6 months;
- •Symptomatic peripheral arterial obstructive disease;
- •Cognitive dysfunction: Moca < 24.
研究组 & 干预措施
Sham group
Participants in the control group (Sham) will perform the same number of sets and 4 cycles, with equalized time to ischemia (4 minutes) and (40 seconds) reperfusion timing, but at a non-occlusive pressure of 30 mmHg (KAATSU C4 device)
干预措施: Sham group (Device)
Ischemic conditioning group
Therapy will be performed bilaterally on the upper limbs. The ischemic conditioning group will perform 4 times, 8 cycles with 30 seconds of ischemia (80 - 200 mmHg) with 5 seconds of reperfusion in each cycle. Ischemia cycles are controlled by a device (KAATSU C4 - KAATSU GLOBAL / USA) In the first cycle, participants will be subjected to pressures of 80 to 150 mmHg. In the 3 subsequent cycles, pressures from 130 to 200 mmHg will be applied.
干预措施: Ischemic conditioning group (Device)
结局指标
主要结局
Unified Parkinson's Disease Rating Scale
时间窗: Before intervention and at week 12
0-260 points: A higher score indicates greater impairment
Montreal cognitive assesment
时间窗: Before intervention and at week 12
Maximum score: 30 points; Normal cognition: 26-30 points; Mild cognitive impairment (MCI): Below 26 points
次要结局
- The Parkinson's Disease Questionnaire-39(Before intervention and at week 12)
- Timed up and go(Before intervention and at week 12)
- Assessment of cellular and soluble immune response(Before intervention and at week 12)
- Quantifications of systemic soluble mediators(Before intervention and at week 12)
- PBMC acquisition and flow cytometry(Before intervention and at week 12)