An interventional study of Aerobic Exercise with Blood Flow Restriction and Aerobic Exercise without Blood Flow Restriction in Parkinson's Disease (PD), Anxiety and Postural Balance, sponsored by National Cheng-Kung University Hospital. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by National Cheng-Kung University Hospital · Not applicable, Interventional, and Treatment
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 54 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →National Cheng-Kung University Hospital is the lead sponsor of 277 studies on the registry; 70 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants perform an aerobic exercise session combined with blood flow restriction
Behavioral: Aerobic Exercise with Blood Flow Restriction
Participants perform the same aerobic exercise session without blood flow restriction
Behavioral: Aerobic Exercise without Blood Flow Restriction
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.
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.
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).
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).
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).
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).
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.
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Plan to share: No
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Start is estimated for Sep 2026; primary completion for Jul 2029, 34 months later.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 34 months is above that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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