Blood Flow Restriction Aerobic Exercise for Balance and Anxiety in Parkinson's Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNational Cheng-Kung University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Aerobic Exercise with Blood Flow Restriction
BehavioralThe 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
BehavioralParticipants 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.
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Aerobic Exercise with Blood Flow RestrictionExperimental treatment 1 intervention
Group B: Aerobic Exercise without Blood Flow RestrictionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Center of Pressure (CoP) Total Displacement
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.
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).2
Change in Physiological Anxiety
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.
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).3
Change in EEG Relative Band Power
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.
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).Secondary outcomes
1
Change in Cognitive Reaction Time During Dual-Task Standing
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.
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).2
Rating of Perceived Exertion (RPE)
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.
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.Locations
Sponsors and contacts
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National Cheng-Kung University Hospital
Lead sponsor
National Cheng Kung University
Sponsor institution
Source ClinicalTrials.gov
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