NCT06508801 · The University of Texas Health Science Center at San Antonio
Blood Flow Restriction for Optimizing Balance in Parkinson's Disease
What this study is about
This study is being done to understand how reducing blood flow (BRT) during balance-challenging strengthening exercises (instability resistance training, or IRT) can help improve symptoms of Parkinson's disease.
View original scientific description
This study is being done to understand how reducing blood flow (BRT) during balance-challenging strengthening exercises (instability resistance training, or IRT) can help improve symptoms of Parkinson's disease.
Interventions
OTHER
Blood flow restriction training
The BFR Intervention will consist of 75 repetitions; reps (set 1: 30 reps, sets 2 - 4: 15 reps with 30 s of rest between sets and 1 minute between exercises) at 20-30% of 10 repetition maximum (RM). BFR training will be performed during toe raises, lunges and single leg stance exercises on unstable surfaces (i.e., foam, Dyna disc, balance disc, and BOSU-ball®) as tolerated by the participant.
OTHER
Instability Resistance Training
The following devices will be used for instability training: foam, dyna disc, balance disc and BOSU-ball®. Unstable devices will be changed during the six-week period from the least to the most unstable devices. Once a participant reduces the body sway on a device, the device will be progressed. Participants will perform IRT with or without blood flow restriction.
Primary outcome measures
Feasibility metric
Time frame: Baseline to 6 weeks
The treatment will be considered acceptable if the dropout and significant adverse event rate is less than 20%, that is no more than 2 out of 10 participants in the treatment group either 1) drop out, 2) withdraw consent, or 3) have a significant adverse event (Grade 3 or higher on 5 point scale where 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death). Results will be reported as percentage of participants that dropped out.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Males and females between the ages 40 - 85 with a diagnosis of idiopathic Parkinson's Disease (PD) consistent with the United Kingdom PD society brain bank criteria,
- in Hoehn and Yahr stage 2-4,
- a score of ≥23 on the mini-Mental Scale Examination.
Exclusion criteria
- History of cardiovascular disease, uncontrolled hypertension (blood pressure ≥140/90 mmHg), orthostatic hypotension, deep-vein thrombosis, varicose veins, or rhabdomyolysis;
- Ankle branchial index ≤ 0.9 or \> 1.3.
- History of other neurological disorders affecting the central nervous system such as stroke, multiple sclerosis, tumors, amyotrophic lateral sclerosis or muscle disease such as muscular dystrophy, myopathy.
- History of uncontrolled diabetes, severe osteoporosis, or cognitive impairment.
- Body mass index above 40; such individuals are more likely to have poorer muscle function and more pain.
- 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
- Had surgery in the lower extremities within the past 6 months.
- Pre-menopausal and not on birth control
- Pregnant or planning to become pregnant within the course of the study
- Plan to have major surgery within 2 months.
Where
- San Antonio, Texas
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 31, 2026 · Source of record for eligibility and locations