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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 1, 2027 → Aug 1, 2028
Primary endpoint removed 2 → 1 primary endpoints
See other at-risk trials from Hospital Israelita Albert Einstein

Record History

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  1. Enrollment increased: 44 → 50 participants
  2. Primary endpoint(s) modified Show 5 more changesShow less
    • Enrollment increased: 34 → 44 participants
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: 5 to 6
    • Publications: details revised at 17 of 17 entries
    • Study description shortened, about 2 words
  3. Re-verified, no change to tracked fieldsv5
  4. Primary completion pushed from Aug 1, 2027 to Aug 1, 2028
    • Start date: Mar 1, 2025 to Oct 1, 2026
    • Study completion pushed from Sep 1, 2027 to Sep 1, 2028
    • Collaborator revised
    v4
  5. Secondary endpoints revised (5)v3
  6. Primary completion date: Apr 1, 2026 to Aug 1, 2027v2 Show 5 more changesShow less
    • Start date: Apr 1, 2024 to Mar 1, 2025
    • Primary endpoints revised (2)
    • Study completion date: Jan 15, 2028 to Sep 1, 2027
    • Secondary endpoints revised (5)
    • Collaborators expanded, about 5 words
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06293118
Lead Sponsor Hospital Israelita Albert Einstein
Collaborators: University of Sao Paulo
Conditions
(from sponsor)		 Parkinson Disease
Related terms Parkinson Disease
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov