Status:
RECRUITING
Blood Flow Restriction and Exercise in Parkinson's Disease
Lead Sponsor:
University of California, San Francisco
Conditions:
Parkinson' Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn whether training with blood flow restriction (BFR), combined with aerobic exercise (performing stepping on a Nu-Step exercise machine), can help improve mob...
Detailed Description
This study's primary objective is to determine the exploratory safety of the combined recumbent stepping + BFR intervention for this population. Secondary aims are to evaluate the exploratory efficacy...
Eligibility Criteria
Inclusion
- Age 18+
- People with advanced Parkinson's disease. "Advanced PD" will include signs of progressed disease including orthostatic hypotension and/or motor issues reflective of postural instability and/or mild-moderate bilateral symptoms (confirmed visually in clinic or home by a medical provider such as an MD/PT and/or documented in the medical record.
- Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
- Diagnosis of idiopathic Parkinson's disease (self-reported okay, documented preferred)
- Independent ambulation (≥10m with or without an assistive device)
- Commitment to participate in the exercise intervention as outlined
- Score of ≥21 on the Montreal Cognitive Assessment (MoCA)
Exclusion
- History of cardiovascular disease, uncontrolled hypertension (blood pressure
- ≥140/90 mmHg), deep-vein thrombosis, varicose veins, or rhabdomyolysis which a patient's primary physician determines would preclude them from safe study participation.
- Ankle branchial index ≤ 0.9 or \> 1.3
- History of or comorbid conditions spanning cardiovascular, neurological, or orthopedic injuries which may prevent for the safe administration of the intervention (a healthcare provider's clearance or guidance will be obtained in these situations to ensure appropriateness), including current medications.
- History of uncontrolled diabetes, BMI \> 40, or severe cognitive impairment (as measured by MoCA \<21)
- Atypical PD diagnoses or ON PD-medication worsening of motor symptoms
- Absolute contraindications to exercise as per the American College of Sports Medicine (uncontrolled arrhythmias, third-degree heart block, recent electrocardiogram (EKG) changes, unstable angina, acute myocardial infarction, or acute congestive heart failure)
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT07221994
Start Date
November 1 2025
End Date
February 1 2026
Last Update
November 6 2025
Active Locations (1)
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1
UCSF Health & Wellness Center (UCSF Mission Bay)
San Francisco, California, United States, 94158