Clinical trial NCT06293118: The Effects of Ischemic Conditioning in Individuals with Parkinson's Disease
Official title: The Chronic Effect of Ischemic Conditioning on Motor Function, Cognitive Performance, and Immune System in Individuals with Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: ischemic conditioning
immune system
motor function
cognitive performance
Parkinson disease
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Unifesp Escola Paulista de Medicina
First posted: 2024-03-05
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Ischemic conditioning group
2. control group (Sham)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* PD patients aged 40 years or older;
* Diagnosis of PD without cognitive complaints or with complaints, but without impact on daily activities;

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale
timeFrame: Before intervention and at week 12
measure: Montreal cognitive assesment
timeFrame: Before intervention and at week 12
Secondary outcomes:
measure: The Parkinson's Disease Questionnaire-39
timeFrame: Before intervention and at week 12
measure: Timed up and go
timeFrame: Before intervention and at week 12
measure: Assessment of cellular and soluble immune response
timeFrame: Before intervention and at week 12
measure: Quantifications of systemic soluble mediators
timeFrame: Before intervention and at week 12
measure: PBMC acquisition and flow cytometry
timeFrame: Before intervention and at week 12
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Kenneth Gollob, PhD
role: PRINCIPAL_INVESTIGATOR
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