Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT07831980

Blood Flow Restriction Aerobic Exercise for Balance and Anxiety in Parkinson's Disease

Conditions: Parkinson's Disease (PD), Anxiety, Postural Balance

Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 54
Sponsor: National Cheng-Kung University Hospital

Summary

Reducing balance problems and anxiety severity are the top two research uncertainties for people with Parkinson's disease (PD). Besides having a mutually aggravating relationship between postural impairment and anxiety severity, dual tasking is a critical condition that would increase postural instability and anxiety level concurrently. High-intensity aerobic exercise could improve balance and reduce anxiety. However, the training benefits from high-intensity aerobic exercise are limited in people with PD due to disease-related symptoms. Blood flow restriction (BFR) has been applied to low-intensity exercise. By creating localized hypoxia and increasing metabolic stress, BFR could facilitate aerobic system and neural adaptations. However, for the PD population, only one study applied BFR to aerobic exercise with the research design of a single-case report, let alone investigating the effects of BFR aerobic exercise on postural control and anxiety level under a dual-task condition. With the measurements of behavioral performance, subjective anxiety questionnaire, skin conductance response, and electroencephalogram (EEG), the purpose of the 3-year research project is to investigate the effects of BFR aerobic exercise on dual-task postural performance, anxiety, and related brain activities in people with PD. In the first year, the investigators will investigate the immediate effect of one bout of BFR aerobic exercise on dual-task postural control and anxiety level. In the second and third years, the investigators will investigate the long-term training effects of BFR aerobic exercise on dual-task postural control, anxiety modulation, brain plasticity, and patient satisfaction. The present project is expected to have significant contributions to gaining a better insight into the neural correlates of balance and anxiety with BFR aerobic exercise, particularly under dual-task conditions, and provide an optimized rehabilitation strategy for people with PD in clinical practice.

Eligibility Criteria

Inclusion Criteria: * Diagnosed with idiopathic Parkinson's disease by a board-certified neurologist specializing in movement disorders. * Early-to-moderate stage of Parkinson's disease, corresponding to Hoehn and Yahr Stages 1 to 3 in the on-medication state. * Absence of other neurological or orthopedic conditions affecting balance and gait (e.g., stroke, vestibular disorders). * Mini-Mental State Examination (MMSE) score ≥ 26, indicating intact cognitive function without significant cognitive impairment. Exclusion Criteria: * Contraindications to blood flow restriction (BFR), including a history of cardiopulmonary disease, pneumonia, varicose veins, diabetes mellitus, or intermittent claudication; uncontrolled/unstable hypertension; active smoking; or currently taking medications that increase the risk of blood clots. * Presence of depressive symptoms that could influence postural control or anxiety assessments, defined as currently taking antidepressant medications or scoring \> 1 on item 1.3 (Depressed mood) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I. * History of neurosurgical procedures, such as Deep Brain Stimulation (DBS). * Color vision deficiency or color blindness, which interferes with the visual color discrimination task.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07831980). StuddyBuddy aggregates publicly available trial information.