4 Participants Needed

Blood Flow Restriction and Exercise for Parkinson's Disease

(BFR-PD Trial)

JE
NA
Overseen ByNatalie Anzures, DPT, NCS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether combining blood flow restriction (gently limiting blood flow with inflatable cuffs) and aerobic exercise can improve movement and quality of life for individuals with advanced Parkinson's disease. Participants will use a Nu-Step machine, a type of exercise equipment, twice a week for eight weeks under professional supervision. The trial seeks participants with advanced Parkinson's disease who can walk independently, even with a walking aid. As an unphased trial, this study offers a chance to contribute to innovative research that may enhance daily living for those with Parkinson's.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that certain medical conditions and medications may require clearance from a healthcare provider to ensure safe participation.

What prior data suggests that this method is safe for people with Parkinson's disease?

Research has shown that blood flow restriction (BFR) training can be safely used by people with Parkinson's disease. One study found that BFR training improved strength and reduced symptoms like restless leg syndrome without major safety issues. However, some reports noted that BFR can cause increased pain, tiredness, and muscle soreness during exercise. Despite these concerns, BFR is generally considered a safe and effective way to build strength, especially under supervision. In middle-aged and older women, BFR training demonstrated benefits such as increased strength and lower blood pressure. While BFR appears promising, individuals should carefully consider their own health conditions before starting.12345

Why are researchers excited about this trial?

Researchers are excited about using blood flow restriction (BFR) with exercise for Parkinson's disease because it offers a novel approach to improving physical function. Unlike traditional treatments like medication or deep brain stimulation, which focus primarily on managing symptoms, this method aims to enhance muscle strength and endurance through a unique mechanism. By partially restricting blood flow during exercise, BFR may amplify the benefits of aerobic activities, potentially providing a safe and effective way to boost movement capabilities in individuals with Parkinson's. This approach could complement existing therapies, offering a promising new avenue for improving quality of life.

What evidence suggests that blood flow restriction and exercise might be an effective treatment for Parkinson's disease?

Studies have shown that combining blood flow restriction (BFR) with exercise can help people with Parkinson's disease become stronger and more functional. In this trial, participants will engage in aerobic exercise using a Nu-Step recumbent stepper combined with lower-extremity BFR. Special cuffs gently reduce blood flow to the legs during exercise, allowing people to build strength even with lighter workouts. Research indicates that this method can improve mobility and reduce symptoms like restless leg syndrome. Additionally, BFR training enhances balance and coordination, which are often challenging for those with Parkinson's. These findings suggest that BFR and exercise together could be a promising way to improve the quality of life for those with the condition.12367

Who Is on the Research Team?

JB

Jessica Bath, DPT, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for people with advanced Parkinson's disease who can safely perform aerobic exercise. Participants will need to commit to twice-weekly training sessions for 8 weeks and complete surveys and tests. They should be able to use a Nu-Step machine with special cuffs that limit blood flow during exercise.

Inclusion Criteria

Ability to understand and sign a written informed consent document
Commitment to participate in the exercise intervention as outlined
Score of ≥21 on the Montreal Cognitive Assessment (MoCA)
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Exclusion Criteria

Absolute contraindications to exercise as per the American College of Sports Medicine
Ankle branchial index ≤ 0.9 or > 1.3
I have no severe heart issues, uncontrolled high blood pressure, or muscle breakdown that would make the study unsafe for me.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Baseline Assessment

Baseline assessments conducted individually with the PI, including consent and initial measurements

1 week
1 visit (in-person)

Treatment

Participants undergo 8 weeks of supervised aerobic stepping exercise with blood flow restriction, including weekly surveys and continuous monitoring

8 weeks
16 visits (in-person), weekly surveys (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of continued intervention effects and short-term durability

4 weeks
1 visit (in-person), weekly surveys (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Blood Flow Restriction and Exercise
Trial Overview The study is testing if combining blood flow restriction (BFR) with aerobic stepping exercises improves mobility in Parkinson's patients more than just the exercises alone. BFR involves wearing inflatable cuffs on the legs while exercising, which may enhance strength gains.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Aerobic exercise (Nu-Step) recumbent stepping and blood flow restriction (BFR)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Citations

Blood Flow Restriction and Exercise in Parkinson's DiseaseThe investigators hypothesize that training with BFR and aerobic exercise will produce enhanced outcomes related to mobility and quality of life ...
THE EFFECTS OF BLOOD FLOW RESTRICTION TRAINING ...The results were that BFR training can produce functional improvements, reduce restless leg syndrome symptoms and can be safely utilized with a subject with PD ...
Blood flow restriction resistance training in a recreationally ...Conclusion: The combination of BFR with LIRT safely lead to an increase in lower extremity strength and function in a person with PD, while decreasing their RLS ...
Effectiveness of Blood Flow Restriction in Neurological ...BFR seems to be beneficial in neurological disorders. Improvements have been found in sensorimotor function, frequency and step length symmetry, perceived ...
Safety and efficacy of blood flow restriction exercise in ...BFRE seems to be a potentially safe and effective training modality in individuals with ND. However, the results should be interpreted cautiously.
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38268066/
Safety and efficacy of blood flow restriction exercise in ...BFRE seems to be a potentially safe and effective training modality in individuals with ND. However, the results should be interpreted cautiously.
Effect of blood flow restriction training on health promotion ...BFR training had a significant effect on the increase of the maximum dynamic force of 1RM and decrease of blood pressure in middle-aged and elderly women.
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