Parkinson' DiseaseBFR-PDNCT07221994
Blood Flow Restriction and Exercise in Parkinson's Disease
A study testing Blood flow restriction (BFR) and aerobic exercise via recumbent stepping (Nu-Step) in people with Parkinson' Disease, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson' Disease
- What is being tested?
- Blood flow restriction (BFR) and aerobic exercise via recumbent stepping (Nu-Step)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2025to 13 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Health & Wellness Center (UCSF Mission Bay)
San Francisco, California, 94158
About this study
Official title: The Effects of Blood Flow Restriction Combined With Low-Intensity Recumbent Stepping in Individuals With Advanced Parkinson's Disease
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.
Read the 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 on the intervention for Parkinson's symptoms including functional mobility, autonomic function, daily step counts, cognition, and quality of life, as well as obtain feasibility and acceptability of the intervention from participants.
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
- Parkinson' Disease
- Being tested
- Blood flow restriction (BFR) and aerobic exercise via recumbent stepping (Nu-Step)
- Keywords
- Parkinson's disease, blood flow restriction, falls, postural instability, exercise
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise (Nu-Step) recumbent stepping and blood flow restriction (BFR) | Experimental | Intervention (aerobic exercise + lower-extremity BFR) Receives: Device: Blood flow restriction (BFR) and aerobic exercise via recumbent stepping (Nu-Step) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
The Unified Parkinson's Disease Rating Scale Motor subscore (UPDRS-III) will be used to determine changes in individuals' overall PD motor severity.
Measured: 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
The "Timed up and Go" test (TUG); single and dual-tasking components will be used to determine whether changes are observed in functional mobility.
Measured: 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
The 5x sit to stand test will be used to assess for changes in functional mobility.
Measured: 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
The number of falls averaged and self-reported by the patient each week will be captured at baseline, then captured throughout the intervention and post-intervention observation period using custom Qualtrics survery which inquires about falls per week.
Measured: 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
The number of episodes of orthostatic hypotension averaged and self-reported by the patient each week will be captured at baseline, then captured throughout the intervention and post-intervention observation period using custom Qualtrics survery which inquires about orthostatic hypotension per week.
Measured: Baseline, 8 weeks following intervention start, then 4 weeks after the end of the intervention (12 weeks total following intervention start).
Improvement of daily activity (step) counts
The number of daily steps averaged and self-reported using the provided study wearable by the patient each week will be captured at baseline, then throughout the intervention and post-intervention observation period using a custom Qualtrics survery which asks participants to self-report (using the smartwatch) averaged step counts.
Measured: Baseline, 8 weeks following intervention start, then 4 weeks after the end of the intervention (12 weeks total following intervention start).
Improvement of cognition
Participant cognition will be measured using the MoCA exam (Montreal Cognitive Exam).
Measured: Baseline, 8 weeks following intervention start, then 4 weeks after the end of the intervention (12 weeks total following intervention start).
Improvement of cognition
Participant cognition will be measured using the Trail-Making-Test (TMT) either online or in-person by the trained PIs.
Measured: Baseline, 8 weeks following intervention start, then 4 weeks after the end of the intervention (12 weeks total following intervention start).
Improvement of Parkinson's disease related quality of life
Participant cognition will be measured using the PD-specific quality of life (PDQ-8) self-reported clinical metric
Measured: Baseline, 8 weeks following intervention start, then 4 weeks after the end of the intervention (12 weeks total following intervention start).
Improvement of lower-extremity muscle strength
Participant strength will be measured using dynamometer testing of quadriceps and hamstrings muscles
Measured: Baseline, 8 weeks following intervention start, then 4 weeks after the end of the intervention (12 weeks total following intervention start).
Intervention Adherence
This will be assessed using PI/participant tracking of the amount of protocol sessions attended by participants.
Measured: 12 weeks total following intervention start-last study data collection point; throughout during 8-week intervention (weekly) using custom Qualtrics Survey.
Participant experience of the intervention
Participant experience and perceptions with the intervention will be assessed formally with participant feedback using the summative custom Qualtrics survey via open-ended feedback at the end of the study, as well as informally throughout the study during live conversations with the PIs.
Measured: 12 weeks total following intervention start-last study data collection point; throughout during 8-week intervention (weekly) using custom Qualtrics Survey.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start21 Nov 2025
- Primary completion7 Apr 2026
- Study completion13 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Parkinson' DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Bath, DPT, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221994
- Sponsor's protocol ID
- 25-44253
- Acronym
- BFR-PD
- Status last verified
- Jun 2026
- First submitted
- 19 Aug 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Aggregated participant data which has been de-identified; likely provided through descriptive statistics and aggregated results only, due to the relatively small sample size to prevent potential identification.
Publications
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.
PubMed 29629527Liao 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.
PubMed 37468360Chen 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.
PubMed 31809788Douris 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.
PubMed 30090683Manago 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.
PubMed 37815934Lopes 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.
PubMed 34055161Franz 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.
PubMed 35774280
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Blood Flow Restriction Combined With Low-Intensity Recumbent Stepping in Individuals With Advanced Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07221994
- Acronym / sponsor ID
- BFR-PD / 25-44253
- Conditions
- Parkinson' Disease
- Keywords
- Parkinson's disease, blood flow restriction, falls, postural instability, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 13 May 2026 (actual)
- First posted
- 29 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 on the intervention for Parkinson's symptoms including functional mobility, autonomic function, daily step counts, cognition, and quality of life, as well as obtain feasibility and acceptability of the intervention from participants.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise (Nu-Step) recumbent stepping and blood flow restriction (BFR) | Experimental | Device: Blood flow restriction (BFR) and aerobic exercise via recumbent stepping (Nu-Step)Intervention (aerobic exercise + lower-extremity BFR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Aerobic exercise (Nu-Step) recumbent stepping and blood flow restriction (BFR) |
Primary outcome
Number of Participants With Treatment-Related Adverse Events as Assessed by Custom Survey & Vitals Monitoring during & post-intervention
Time frame: 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.
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).
12 secondary outcomes
Overall PD motor severity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 8 weeks following intervention start, then 4 weeks after the end of the intervention (12 weeks total following intervention start).
Improvement of daily activity (step) counts
Time frame: Baseline, 8 weeks following intervention start, then 4 weeks after the end of the intervention (12 weeks total following intervention start).
Improvement of cognition
Time frame: Baseline, 8 weeks following intervention start, then 4 weeks after the end of the intervention (12 weeks total following intervention start).
Improvement of cognition
Time frame: Baseline, 8 weeks following intervention start, then 4 weeks after the end of the intervention (12 weeks total following intervention start).
Improvement of Parkinson's disease related quality of life
Time frame: Baseline, 8 weeks following intervention start, then 4 weeks after the end of the intervention (12 weeks total following intervention start).
Improvement of lower-extremity muscle strength
Time frame: Baseline, 8 weeks following intervention start, then 4 weeks after the end of the intervention (12 weeks total following intervention start).
Intervention Adherence
Time frame: 12 weeks total following intervention start-last study data collection point; throughout during 8-week intervention (weekly) using custom Qualtrics Survey.
Participant experience of the intervention
Time frame: 12 weeks total following intervention start-last study data collection point; throughout during 8-week intervention (weekly) using custom Qualtrics Survey.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 29629527Chang 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.
- Background: PubMed 37468360Liao 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.
- Background: PubMed 31809788Chen 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.
- Background: PubMed 30090683Douris 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.
- Background: PubMed 37815934Manago 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.
- Background: PubMed 34055161Lopes 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.
- Background: PubMed 35774280Franz 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.
- Individual participant dataSharing planned: Yes. Aggregated participant data which has been de-identified; likely provided through descriptive statistics and aggregated results only, due to the relatively small sample size to prevent potential identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Bath, DPT, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction (BFR) and aerobic exercise via recumbent stepping (Nu-Step) in people with Parkinson' Disease, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Related Adverse Events as Assessed by Custom Survey & Vitals Monitoring during & post-intervention (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07221994, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.