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Blood Flow Restriction for Optimizing Balance in Parkinson's Disease

NCT06508801 · The University of Texas Health Science Center at San Antonio
In plain English

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About this study
Parkinson's disease (PD) is a disease of the nervous system that attacks the nerve cells in the brain responsible for controlling movement in the arms, legs and face. It is a progressive condition that gets worse with time. The purpose of this study is to determine the effects of blood flow restriction (BFR) in combination with strengthening exercises that challenge balance (instability resistance training (IRT)) to improve the symptoms of the participant's condition. This research is being done to understand the effects of BFR with IRT on symptoms of PD such as balance, mobility, walking and endurance. There will be two groups 1 and 2; group 1 will perform IRT with BFR and group 2 will perform IRT only. Each session with either intervention will last approximately 45 minutes. Researchers will test the effects of the intervention on the participant's walking ability, balance function and endurance. The researchers hope to learn whether low resistance exercises using these tight cuffs around the thighs are well tolerated by individuals with PD and determine whether there is an improvement in muscle strength, balance, and physical function. In addition, researchers will also use peripheral nerve stimulation techniques which are non-invasive (does not go inside the body). These techniques will be used to measure spinal excitability (i.e., nerve stimulator for testing strength of the pathway between spinal cord and muscles) in individuals with PD.
Eligibility criteria
Inclusion Criteria: 1. 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, 2. in Hoehn and Yahr stage 2-4, 3. a score of ≥23 on the mini-Mental Scale Examination. Exclusion Criteria: 1. History of cardiovascular disease, uncontrolled hypertension (blood pressure ≥140/90 mmHg), orthostatic hypotension, deep-vein thrombosis, varicose veins, or rhabdomyolysis; 2. Ankle branchial index ≤ 0.9 or \> 1.3. 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. 4. History of uncontrolled diabetes, severe osteoporosis, or cognitive impairment. 5. Body mass index above 40; such individuals are more likely to have poorer muscle function and more pain. 6. 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 7. Had surgery in the lower extremities within the past 6 months. 8. Pre-menopausal and not on birth control 9. Pregnant or planning to become pregnant within the course of the study 10. Plan to have major surgery within 2 months.
Study design
Enrollment target: 20 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-01-07
Estimated completion: 2026-12
Last updated: 2026-03-31
Interventions
Other: Blood flow restriction trainingOther: Instability Resistance Training
Primary outcomes
  • Feasibility metric (Baseline to 6 weeks)
Sponsor
The University of Texas Health Science Center at San Antonio · other
With: National Institute on Aging (NIA)
Contacts & investigators
ContactAnjali Sivaramakrishnan, PhD, PT · contact · sivaramakris@uthscsa.edu · 210-567-8626
ContactAlyssa Main · contact · baezaa1@uthscsa.edu · 210-567-8767
InvestigatorAnjali Sivaramakrishnan, PhD, PT · principal_investigator, The University of Texas Health Science Center at San Antonio
All locations (1)
University of Texas Health Science Center at San AntonioRecruiting
San Antonio, Texas, United States