Blood Flow Restriction and Exercise in Parkinson's Disease
NCT ID: NCT07221994
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
4 participants
INTERVENTIONAL
2025-11-01
2026-02-28
Brief Summary
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BFR uses inflatable cuffs placed on participants' upper legs to gently reduce blood flow to the legs while exercising. This has been shown in studies in older adults and Parkinson's disease to improve strength while training with lighter loads, which may be helpful for people with Parkinson's.
Participants will be asked to complete 2 weekly training sessions (approximately 30 minutes each) for 8 weeks consisting of supervised aerobic stepping exercise on a Nu-step machine with BFR application during timed intervals. In addition to the training sessions, participants will be asked to periodically perform confidential surveys and tests related to function and disease symptoms, and wear a provided smartwatch (which can be kept upon successful completion of the study). All sessions involve individual monitoring and medical supervision by licensed physical therapists as well as access to all necessary equipment.
Detailed Description
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This is a pilot clinical trial (pre-post) which will investigate the safety, feasibility, and exploratory effectiveness of a novel, 8-week clinical trial with BFR + low-intensity recumbent stepping for advanced PD in 4 participants. Data will be collected at three time-points: baseline, after the 8-week intervention, and at 4-weeks post-intervention cessation to assess for continued longitudinal intervention effects and short-term durability. Findings will guide optimization, scalability, and future clinical implementation via larger randomized controlled trials and protocol refinement as appropriate.
Screening, consent, and baseline assessments will be conducted individually with the PI; all participants will continue their prescribed Parkinson's medications during the study. Participants will be given a fitness tracker watch and training as needed, then complete the 8-week intervention with continuous monitoring by one of the investigators using heart rate, SpO2, rate of perceived exertion (RPE), and blood pressure (BP) taken before and/or during and after the intervention.
BFR Intervention Details: Participants will perform recumbent stepping (legs only) using a Nu-Step machine as detailed above, with Fit Cuffs®' BFR straps wrapped around their bilateral proximal thighs at 40% arterial occlusion pressure (remaining consistent throughout the protocol). The arterial occlusion pressure at rest (rAOP) will be assessed using a FitCuffs® pressure system and pulse oximeter. The cuffs will be inflated until the distal pulse (measured at the toe) is no longer detectable. The corresponding pressure will be recorded as the rAOP and used to calculate the BFR training pressure at 40% rAOP. In the case of issue using the device, a doppler ultrasound will be used at the dorsalis pedis artery to check for occlusion and associated pressure.
Weekly surveys will be emailed to participants for input of their daily (averaged) step counts during that week, falls, heart rate variability, and feedback regarding the intervention, with participant follow-up performed by the investigators as appropriate.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Aerobic exercise (Nu-Step) recumbent stepping and blood flow restriction (BFR)
Intervention (aerobic exercise + lower-extremity BFR)
Blood flow restriction (BFR) and aerobic exercise via recumbent stepping (Nu-Step)
This intervention involves the combined application of training with BFR and aerobic exercise via recumbent stepping on a Nu-Step machine. The intervention will be administered to all study participants, twice-weekly, for 8 weeks.
Interventions
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Blood flow restriction (BFR) and aerobic exercise via recumbent stepping (Nu-Step)
This intervention involves the combined application of training with BFR and aerobic exercise via recumbent stepping on a Nu-Step machine. The intervention will be administered to all study participants, twice-weekly, for 8 weeks.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
4. Diagnosis of idiopathic Parkinson's disease (self-reported okay, documented preferred)
5. Independent ambulation (≥10m with or without an assistive device)
6. Commitment to participate in the exercise intervention as outlined
7. Score of ≥21 on the Montreal Cognitive Assessment (MoCA)
Exclusion Criteria
≥140/90 mmHg), deep-vein thrombosis, varicose veins, or rhabdomyolysis which a patient's primary physician determines would preclude them from safe study participation.
2. Ankle branchial index ≤ 0.9 or \> 1.3
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.
4. History of uncontrolled diabetes, BMI \> 40, or severe cognitive impairment (as measured by MoCA \<21)
5. Atypical PD diagnoses or ON PD-medication worsening of motor symptoms
6. 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)
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Jessica Bath, DPT, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF Health & Wellness Center (UCSF Mission Bay)
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Jessica Bath, DPT, PhD
Role: primary
Casey McCraig
Role: backup
References
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Chang HC, Lu CS, Chiou WD, Chen CC, Weng YH, Chang YJ. An 8-Week Low-Intensity Progressive Cycling Training Improves Motor Functions in Patients with Early-Stage Parkinson's Disease. J Clin Neurol. 2018 Apr;14(2):225-233. doi: 10.3988/jcn.2018.14.2.225.
Liao JY, Bohnen NI. Is heart rate variability the heart of the matter for freezing of gait? Parkinsonism Relat Disord. 2023 Aug;113:105763. doi: 10.1016/j.parkreldis.2023.105763. Epub 2023 Jul 11. No abstract available.
Chen Z, Li G, Liu J. Autonomic dysfunction in Parkinson's disease: Implications for pathophysiology, diagnosis, and treatment. Neurobiol Dis. 2020 Feb;134:104700. doi: 10.1016/j.nbd.2019.104700. Epub 2019 Dec 3.
Douris PC, Cogen ZS, Fields HT, Greco LC, Hasley MR, Machado CM, Romagnuolo PM, Stamboulis G, DiFrancisco-Donoghue J. THE EFFECTS OF BLOOD FLOW RESTRICTION TRAINING ON FUNCTIONAL IMPROVEMENTS IN AN ACTIVE SINGLE SUBJECT WITH PARKINSON DISEASE. Int J Sports Phys Ther. 2018 Apr;13(2):247-254.
Manago MM, Cohen ET, Alvarez E, Hager ER, Owens JG, Bade M. Feasibility of Low-Load Resistance Training Using Blood Flow Restriction for People With Advanced Multiple Sclerosis: A Prospective Cohort Study. Phys Ther. 2024 Jan 1;104(1):pzad135. doi: 10.1093/ptj/pzad135.
Lopes KG, Farinatti P, Bottino DA, DE Souza MDGC, Maranhao PA, Bouskela E, Lourenco RA, DE Oliveira RB. Does Resistance Training with Blood Flow Restriction Affect Blood Pressure and Cardiac Autonomic Modulation in Older Adults? Int J Exerc Sci. 2021 Apr 1;14(3):410-422. doi: 10.70252/OXXF4710. eCollection 2021.
Franz A, Ji S, Bittersohl B, Zilkens C, Behringer M. Impact of a Six-Week Prehabilitation With Blood-Flow Restriction Training on Pre- and Postoperative Skeletal Muscle Mass and Strength in Patients Receiving Primary Total Knee Arthroplasty. Front Physiol. 2022 Jun 14;13:881484. doi: 10.3389/fphys.2022.881484. eCollection 2022.
Other Identifiers
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25-44253
Identifier Type: -
Identifier Source: org_study_id