Blood Flow Restriction and Exercise in Parkinson's Disease

NCT07221994 | Active Not Recruiting FDA Device

• 1 other identifier: 25-44253
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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 mobility and other outcomes in people with progressed Parkinson's disease. The investigators hypothesize that training with BFR and aerobic exercise will produce enhanced outcomes related to mobility and quality of life. 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.

Conditions

Parkinson' Disease

Keywords

Parkinson's disease; blood flow restriction; falls; postural instability; exercise

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events as Assessed by Custom Survey & Vitals Monitoring during & post-intervention

  Treatment-Related Adverse Events will be assessed during session using heart rate (HR), rate of perceived exertion (RPE), and subjective interview for tolerance, fatigue, and pain, as well as use a Custom Qualtrics survey which each participant will fill out each week to illuminate potential adverse events and whether they had worsening of PD motor symptoms, changes in sleep or activity scores, and/or something they would like to disclose to study personnel (free text reponse).

  Participants will be monitored continuously during each session (vitals and response via subjective report), then each week, throughout the 8-week study intervention and 4-weeks post-intervention.

Secondary Outcomes (12)

• Overall PD motor severity

  Baseline, 8 weeks following intervention start, then 4 weeks after the end of the intervention (12 weeks total following intervention start).

• Improvement of functional mobility

  Baseline, 8 weeks following intervention start, then 4 weeks after the end of the intervention (12 weeks total following intervention start).

• Improvement of functional mobility

  Baseline, 8 weeks following intervention start, then 4 weeks after the end of the intervention (12 weeks total following intervention start).

• Improvement of fall incidence

  Baseline, 8 weeks following intervention start, then 4 weeks after the end of the intervention (12 weeks total following intervention start).

• Improvement of orthostatic incidence

  Baseline, 8 weeks following intervention start, then 4 weeks after the end of the intervention (12 weeks total following intervention start).

Study Arms (1)

Aerobic exercise (Nu-Step) recumbent stepping and blood flow restriction (BFR)

EXPERIMENTAL

Intervention (aerobic exercise + lower-extremity BFR)

Device: Blood flow restriction (BFR) and aerobic exercise via recumbent stepping (Nu-Step)

Interventions

Blood flow restriction (BFR) and aerobic exercise via recumbent stepping (Nu-Step) DEVICE

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.

Aerobic exercise (Nu-Step) recumbent stepping and blood flow restriction (BFR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Health & Wellness Center (UCSF Mission Bay)

San Francisco, California, 94158, United States

Location

Related Publications (7)

• 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.

  PMID: 29629527 BACKGROUND

• 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.

  PMID: 37468360 BACKGROUND

• 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.

  PMID: 31809788 BACKGROUND

• 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.

  PMID: 30090683 BACKGROUND

• 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.

  PMID: 37815934 BACKGROUND

• 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.

  PMID: 34055161 BACKGROUND

• 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.

  PMID: 35774280 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Jessica Bath, DPT, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: October 29, 2025
• Study Start: November 21, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 6 months following study completion.
• Access Criteria: Researchers and other interested parties will be asked to contact the PI via email. Data will only be shared as detailed above (aggregated, de-identified data) in alignment with UCSF IRB protocol.

Locations

US (1)