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NCT06508801 | RECRUITING | Parkinson's Disease and Parkinsonism

Blood Flow Restriction for Optimizing Balance in Parkinson's Disease
Sponsor:

The University of Texas Health Science Center at San Antonio

Information provided by (Responsible Party):

Anjali Sivaramakrishnan

Brief Summary:

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.

Condition or disease

Parkinson's Disease and Parkinsonism

Intervention/treatment

Blood flow restriction training

Instability Resistance Training

Phase

NA

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : DOUBLE
Masking Description : This study will utilize block randomization with permuted blocks in a 1:1 ratio. Individuals will be assigned to either Group 1 or Group 2 after baseline assessment. The randomization will be predetermined, and the allocation will be concealed. Only the statistician and research coordinator will be aware of the randomization.
Primary Purpose : SUPPORTIVE_CARE
Official Title : Blood Flow Restriction for Optimizing Balance in Parkinson's Disease
Actual Study Start Date : 2025-01-07
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Blood Flow Restriction for Optimizing Balance in Parkinson's Disease

Location Details

NCT06508801

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How to Participate

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Locations

RECRUITING

United States, Texas

University of Texas Health Science Center at San Antonio

Saint Anthony, Texas, United States, 78229