Blood Flow Restriction for Optimizing Balance in Parkinson's Disease

Overview

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.

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.

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]

Secondary outcome measures (9)

• Balance Measure [Time frame: Baseline to 14 weeks]
• Functional Mobility [Time frame: Baseline to14 weeks]
• Movement Disorder Society Unified Parkinson's Disease Rating Scale [Time frame: Baseline to 14 weeks]
• Postural Sway (Biosway) [Time frame: Baseline to 14 weeks]
• Spinal Excitability Assessment [Time frame: Baseline to 14 weeks]
• Hip abductor muscle strength [Time frame: Baseline to 14 weeks]
• Knee extensor muscle strength [Time frame: Baseline to 14 weeks]
• Ankle plantar flexor muscle strength [Time frame: Baseline to 14 weeks]
• Quality of Life PDQ-39 Questionnaire [Time frame: Baseline to 14 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• University of Texas Health Science Center at San Antonio — San Antonio

Identifiers

NCT: NCT06508801 · STUDY00000472BFR · P30AG044271

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗