The Effects of Ischemic Conditioning in Individuals With Parkinson's Disease

Sponsor
Hospital Israelita Albert Einstein
Study ID
NCT06293118
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Ischemic conditioning group — DEVICE
    The 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 — DEVICE
    In 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.

Study Details

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.

Key Dates

First listed
Mar 5, 2024
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Aug 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Sham Comparator: 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)

Primary Outcome Measure

Unified Parkinson's Disease Rating Scale [ Time Frame: Before intervention and at week 12 ]

Central Contacts

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