Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07831980

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Parkinson's Disease (PD) Anxiety Anxiety Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Postural Balance Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic Exercise with Blood Flow Restriction

Behavioral

The exercise protocol includes:

  • A 5-minute warm-up walking period with speed gradually increased based on individual capability.
  • Three 10-minute bouts of treadmill walking at a moderate intensity of 45% to 50% heart rate reserve (HRR), with a 1-minute rest interval between bouts. HRmax is estimated as 207 - (0.7 × age), and target HR is calculated as (HRmax - HRresting) × (45% to 50%) + HRresting.
  • A 5-minute cool-down walking period at the end.

For the BFR intervention:

  • Inflatable cuffs are secured bilaterally around the proximal thighs.
  • Individual arterial occlusion pressure (AOP) for both lower extremities is determined while the participant stands on a stable surface.
  • An individualized pressure of 60% AOP is applied during the treadmill exercise bouts and deflated during the 1-minute rest intervals between bouts.

Aerobic Exercise without Blood Flow Restriction

Behavioral

Participants will perform the identical supervised aerobic treadmill exercise protocol as the BFR session, but without blood flow restriction:

  • A 5-minute warm-up walking period.
  • Three 10-minute bouts of treadmill walking at 45% to 50% heart rate reserve (HRR), with a 1-minute rest interval between bouts (HRmax = 207 - 0.7 × age; target HR = [HRmax - HRresting] × [45% to 50%] + HRresting).
  • A 5-minute cool-down walking period. No cuff pressure will be applied during this session.

Primary outcomes

  1. Change in Center of Pressure (CoP) Total Displacement

    Time frame: Assessed at baseline (pre-exercise) and immediately after the exercise session (post-exercise) in each of the two crossover visits (separated by 6-8 days).

    Postural control will be evaluated by measuring total center of pressure (CoP) trajectory displacement during quiet standing (single-task condition) on a force platform. Total displacement represents the overall trajectory length of sway path. Values will be reported as the change from pre-exercise to post-exercise.

  2. Change in Physiological Anxiety

    Time frame: Assessed at baseline (pre-exercise) and immediately after the exercise session (post-exercise) in each of the two crossover visits (separated by 6-8 days).

    Physiological anxiety: Mean skin conductance level (SCL) calculated from second 11 to 60 during task execution minus the resting baseline conductance level (measured in microsiemens, µS). Higher values indicate greater sympathetic activation and physiological anxiety.

  3. Change in EEG Relative Band Power

    Time frame: Assessed at baseline (pre-exercise) and immediately after the exercise session (post-exercise) in each of the two crossover visits (separated by 6-8 days).

    Continuous electroencephalography (EEG) signals will be preprocessed and analyzed offline (including DC shift correction, blink artifact removal, and band-pass filtering at 1-50 Hz). Relative frequency band power will be computed using Fourier transform across regions of interest. Relative band power is calculated as the ratio of power within a specific frequency band to the total spectral power (1-50 Hz) and expressed as a percentage. Changes from pre-exercise to post-exercise will be assessed for both testing sessions.

Secondary outcomes

  1. Change in Cognitive Reaction Time During Dual-Task Standing

    Time frame: Assessed at baseline (pre-exercise) and immediately after the exercise session (post-exercise) in each of the two crossover visits (separated by 6-8 days).

    Cognitive performance under the dual-task condition will be assessed using a light-color discrimination task performed concurrently with standing. Reaction time will be measured as the time elapsed from stimulus onset to the participant's response. Values will be evaluated as the change from pre-exercise to post-exercise.

  2. Rating of Perceived Exertion (RPE)

    Time frame: Assessed during the exercise session (at the end of each 10-minute exercise bout and immediately post-exercise) in each of the two crossover visits.

    Exercise intensity and subjective physical exertion will be monitored using the Borg 6-20 RPE Scale. The scale ranges from 6 (no exertion at all) to 20 (maximal exertion). Higher scores indicate greater perceived physical effort.

Study contacts

Contact information is provided by the study sponsor or research team.

Cheng-Ya Huang

CONTACT

[email protected]

886-6-2353535 ext. 5022

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

Investigating the Effects of Aerobic Exercise With Blood Flow Restriction on Dual-task Postural Control and Anxiety Modulation in Patients With Parkinson's Disease

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.