Blood Flow Restriction Training for Parkinson's Disease

Overseen By Alyssa Main

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Cardiovascular disease, Hypertension, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if reducing blood flow during specific strengthening exercises can improve symptoms in people with Parkinson's disease. The study will test two groups: one will perform exercises with blood flow restriction, while the other will do the exercises without it. Ideal participants are those diagnosed with Parkinson's disease who experience significant balance issues. As an unphased study, this trial allows participants to contribute to innovative research that could lead to new therapeutic strategies for Parkinson's disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that blood flow restriction training and instability resistance training are safe for Parkinson's disease patients?

Research has shown that blood flow restriction (BFR) training is generally safe for people with Parkinson's disease. Studies have found it can improve movement and reduce symptoms without major safety concerns. Minor risks include a small chance of muscle damage (1.9%) and fainting (3.8%), but these are rare. Overall, BFR training appears to be a promising and well-tolerated exercise option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about blood flow restriction (BFR) training for Parkinson's disease because it offers a new approach to managing symptoms. Unlike traditional treatments like medication and physical therapy, which primarily aim to manage symptoms and improve mobility over time, BFR training combines low-intensity exercise with restricted blood flow to enhance muscle strength and endurance more efficiently. This method could potentially allow for similar benefits to high-intensity workouts but with less strain on the body, which is particularly beneficial for individuals with Parkinson's. Additionally, when paired with instability resistance training (IRT), there’s potential for even greater improvements in balance and coordination, addressing key challenges faced by those with Parkinson's disease.

What evidence suggests that this trial's treatments could be effective for Parkinson's disease?

Research has shown that blood flow restriction (BFR) training can improve strength and muscle function in individuals with neurological conditions like Parkinson's disease. In this trial, participants in the BFR plus Instability Resistance Training group will receive a combination of these therapies. One study found that BFR training improved movement and reduced symptoms such as restless legs. Another study suggested that BFR might be more effective than high-intensity training for enhancing heart and blood vessel health in those with Parkinson's. Reviews indicate that BFR offers benefits in both the short and medium term, making it a promising option for boosting strength and balance. Overall, BFR training appears to be a safe and effective way to help manage Parkinson's symptoms. ^{1 5 6 7 8}

Who Is on the Research Team?

Anjali Sivaramakrishnan, PhD, PT

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

Inclusion Criteria

A score of ≥23 on the mini-Mental Scale Examination

My Parkinson's disease is at a moderate to advanced stage.

I am between 40-85 years old and have been diagnosed with Parkinson's Disease.

Exclusion Criteria

Ankle branchial index ≤ 0.9 or > 1.3

I have a history of heart disease or uncontrolled high blood pressure.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will receive either Blood Flow Restriction plus Instability Resistance Training or Instability Resistance Training only, with 2 sessions per week over 6 weeks

6 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of balance, mobility, and muscle strength

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Blood flow restriction training
• Instability Resistance Training

How Is the Trial Designed?

Group I: IRT Only Control Group Experimental Treatment 1 Intervention

Instability Resistance Training only group. Participants will receive 2 sessions per week over 6 weeks.

Group II: BFR plus IRT Group Experimental Treatment 2 Interventions

Blood Flow Restriction plus Instability Resistance Training group. Participants will receive 2 sessions per week over 6 weeks.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A 12-week progressive resistance training program significantly improved cardiac autonomic modulation in patients with Parkinson's disease, as evidenced by a notable decrease in the low-frequency component of heart rate variability.

The training also enhanced cardiovascular responses to stress tests, with the PDT group showing a greater reduction in systolic blood pressure during orthostatic stress, achieving levels comparable to healthy controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Progressive Resistance Training on Cardiovascular Autonomic Regulation in Patients With Parkinson Disease: A Randomized Controlled Trial. Kanegusuku, H., Silva-Batista, C., Peçanha, T., et al.[2018]

Blood flow restriction training (BFRT) is generally safe for patients with musculoskeletal disorders, with a systematic review of 19 studies involving 322 participants showing that most did not report adverse events.

While some rare adverse events were noted, such as deep vein thrombosis and rhabdomyolysis, individuals undergoing BFRT did not experience more adverse events compared to those doing regular exercise, indicating its potential as a safe strengthening method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review. Minniti, MC., Statkevich, AP., Kelly, RL., et al.[2020]

Blood flow restriction (BFR) training during low-intensity exercise led to significant functional improvements in a 65-year-old male with Parkinson Disease, enhancing motor function, gait, and endurance over a six-week period.

The subject experienced no adverse effects from the BFR intervention, indicating that it is a safe and effective method for improving symptoms associated with Parkinson Disease and Restless Leg Syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

THE EFFECTS OF BLOOD FLOW RESTRICTION TRAINING ON FUNCTIONAL IMPROVEMENTS IN AN ACTIVE SINGLE SUBJECT WITH PARKINSON DISEASE. Douris, PC., Cogen, ZS., Fields, HT., et al.[2022]

A survey of 112 healthcare professionals revealed that 89% believe blood flow restriction (BFR) training is safe for individuals with neurologic conditions, indicating a positive perception of its safety despite limited evidence.

While 38% of respondents reported using BFR, primarily with resistance training to improve strength, the most common side effect was intolerance to pressure, with no serious medical issues reported, highlighting the need for further research to validate its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical use of blood flow restriction in people with neurologic conditions: a cross-sectional survey. Mañago, MM., Kimbrell, K., Hager, ER., et al.[2022]

Blood flow restriction training (BFRt) was successfully applied to a 30-year-old woman with relapsing-remitting Multiple Sclerosis, leading to significant improvements in strength and balance over 8 weeks of treatment, with no adverse events reported.

This case report suggests that BFRt can be an effective intervention for enhancing physical function in individuals with MS, highlighting the need for further research to explore its broader applicability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood flow restriction training for an individual with relapsing-remitting multiple sclerosis: a case report. Brown, AJ., Rachal Sant, L.[2022]

Upper-limb forced exercise using a specially designed device led to significant improvements in Parkinson's disease symptoms, as measured by the Unified Parkinson Disease Rating Scale (UPDRS)-III, cognitive scales, and balance after 2 months of training.

Neuroimaging results indicated increased cerebral blood flow and enhanced functional connectivity in key brain areas associated with motor control, suggesting that upper-limb exercise may promote compensatory mechanisms in the brain to counteract the effects of Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional and Brain Activation Changes Following Specialized Upper-Limb Exercise in Parkinson's Disease. Messa, LV., Ginanneschi, F., Momi, D., et al.[2020]

A study involving 35 individuals with Parkinson's disease showed that both periodized resistance training with functional exercises and traditional resistance training significantly improved functional capacity, balance, and strength over 12 weeks.

The group that included functional training specifically showed improvements in freezing of gait, while traditional resistance training led to notable improvements in motor symptoms, suggesting tailored exercise programs can effectively address different challenges faced by individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periodized Resistance Training With and Without Functional Training Improves Functional Capacity, Balance, and Strength in Parkinson's Disease. Strand, KL., Cherup, NP., Totillo, MC., et al.[2023]

Exercise training may help alleviate symptoms and slow the progression of Parkinson's disease, but patients experience altered cardiovascular responses during exercise due to autonomic nervous system dysfunction.

Understanding how the body maintains blood flow and pressure during exercise in Parkinson's patients is crucial, as it can inform better exercise strategies and interventions for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Altered cardiorespiratory regulation during exercise in patients with Parkinson's disease: A challenging non-motor feature. Sabino-Carvalho, JL., Vianna, LC.[2020]

Resistance training (RT) significantly improves leg strength (SMD = 0.79) and balance capability (SMD = 0.34) in individuals with Parkinson's disease, based on a meta-analysis of 31 studies involving 1,239 participants.

RT also enhances quality of life (MD = -7.22) and shows improvements in gait performance, particularly in fast gait velocity and timed-up-and-go tests, indicating its potential as an effective rehabilitation strategy for managing motor symptoms in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower Limb Resistance Training in Individuals With Parkinson's Disease: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials. Li, X., He, J., Yun, J., et al.[2020]

A systematic review of seven studies involving 401 participants with Parkinson's disease found that moderate intensity resistance training significantly improved muscle strength, balance, and motor symptoms after 8-10 weeks of training, with sessions occurring 2-3 times per week.

The effectiveness of resistance training was highlighted by a significant standardized mean difference (SMD) of 0.61 for muscle strength and 0.48 for motor symptoms, indicating that this type of exercise can be beneficial for individuals with early to moderate stages of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of resistance training on muscle strength and physical function in people with Parkinson's disease: a systematic review and meta-analysis. Chung, CL., Thilarajah, S., Tan, D.[2018]

Blood flow restriction combined with low intensity resistance training (BFR-LIRT) significantly improved lower extremity strength and function in a recreationally active individual with Parkinson Disease over an 18-week period.

The intervention also led to a reduction in Restless Leg Syndrome symptoms, improving from moderate to mild, which contributed to a better quality of life for the participant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood flow restriction resistance training in a recreationally active person with Parkinson's disease. Douris, PC., D'Agostino, N., Werner, WG., et al.[2022]

Blood flow-restricted resistance training (BFR-RT) is safe and effective for improving systolic blood pressure in patients with coronary artery disease (CAD), showing a significant reduction of 10 mm Hg after 8 weeks of training.

BFR-RT combined with aerobic training did not negatively affect hemostatic markers, indicating it can be a beneficial addition to cardiac rehabilitation programs without adverse effects on blood clotting factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic and Hemostatic Response to Blood Flow Restriction Resistance Exercise in Coronary Artery Disease: A Pilot Randomized Controlled Trial. Kambič, T., Novaković, M., Tomažin, K., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6063055/

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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38701159/

Effects of Blood Flow Restriction Resistance Training on ... Conclusions: LIRT-BFR may be more effective than HIRT for autonomic and endothelial function improvements in PwPD and hemodynamic loads may be lessened in LIRT ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06508801

Study Details | NCT06508801 | Blood Flow Restriction for ... The purpose of this study is to determine the effects of blood flow restriction (BFR) in combination with strengthening exercises that challenge balance ( ...

4. mdpi.com mdpi.com/2227-9032/10/12/2407

Effectiveness of Blood Flow Restriction in Neurological ... A recently published review concluded that the application of the BFR technique can produce short- and medium-term benefits in increasing strength, muscle ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/sms.14561

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.gov pubmed.ncbi.nlm.nih.gov/30090683/

THE EFFECTS OF BLOOD FLOW RESTRICTION ... 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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05806775

Low-load Resistance Training With Blood Flow Restriction ... Outcomes assessed before and immediately after the 8-week intervention will include quantitative muscle strength and mobility assessments, and quantitative and ...

8. academic.oup.com academic.oup.com/milmed/article/187/9-10/1059/6548011

Overall Safety and Risks Associated with Blood Flow ... The incidence of rhabdomyolysis and fainting were reported to be 1.9% and 3.8%, respectively.23 In the other study surveying 250 exercise/ ...