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 cognitive performance of patients with Parkinson's disease. Furthermore, the investigators will evaluate secondary outcomes such as the motor function, mobility, quality of life, and immunological responses.
PD patients aged 40 years or older;
Diagnosis of PD without cognitive complaints or with complaints, but without impact on daily activities;
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);
Parallel
Ischemic conditioning group
DeviceThe ischemic conditioning protocol will consist of a period of 12 weeks (24 sessions) with a frequency of 2 weekly sessions lasting between 15 and 20 minutes each. 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) with customized ischemia programs, partially restricting blood flow through special pressure cuffs that are internally valved, providing greater comfort and safety for these patients who typically have stiffness in the affected limb and localized muscle pain. 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.
Sham group
DeviceIn the sham group, participants will complete the same number of sets (4) and 4 cycles, with equalized time to ischemia (4 minutes) and (40 seconds) reperfusion timing, but at a non-occlusive pressure of 30 mmHg. Device, cuff placement, instructions, staff contact, and session duration will be standardized across groups.
Montreal cognitive assesment
Maximum score: 30 points; Normal cognition: 26-30 points; Mild cognitive impairment (MCI): Below 26 points
The Parkinson's Disease Questionnaire-39
The overall score ranges from 0 to 100%, with higher scores indicating a greater negative impact of Parkinson's Disease on the patient's quality of life.
Unified Parkinson's Disease Rating Scale
0-260 points: A higher score indicates greater impairment
Timed up and go
\<10 seconds: Individuals are generally able to perform most daily activities independently without assistance; 10-19 seconds: Indicates independence in most daily activities but may suggest slight mobility limitations; 20-29 seconds: Suggests the need for assistance with mobility, especially for more challenging tasks; ≥30 seconds: Indicates a high fall risk, and the individual likely needs assistance with many daily tasks and may require mobility aids.
Assessment of cellular and soluble immune response
The patient's peripheral blood will be collected in three EDTA tubes of 5 mL each before and after 12 weeks of application of the ischemic conditioning protocol. From the blood samples, plasma will be obtained for quantification of soluble mediators, followed by the isolation/storage of peripheral blood mononuclear cells (PBMC or Peripheral Blood Mononuclear Cell) for phenotypic characterization of subpopulations of T and B lymphocytes, NK cells, myeloids and monocytes
Click on the lead sponsor to view all of their trials.
Hospital Israelita Albert Einstein
Lead sponsor
University of Sao Paulo
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
