Parkinson's Disease (PD)NCT07831980
Blood Flow Restriction Aerobic Exercise for Balance and Anxiety in Parkinson's Disease
A study testing Aerobic Exercise with Blood Flow Restriction and Aerobic Exercise without Blood Flow Restriction in people with Parkinson's Disease (PD) and Anxiety, run by National Cheng-Kung University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease (PD), Anxiety, Postural Balance
- What is being tested?
- Aerobic Exercise with Blood Flow Restriction and Aerobic Exercise without Blood Flow Restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
- Conditions
- Parkinson's Disease (PD), Anxiety, Postural Balance
- Being tested
- Aerobic Exercise with Blood Flow Restriction, Aerobic Exercise without Blood Flow Restriction
- Keywords
- Blood Flow Restriction, Parkinson's Disease (PD), Aerobic exercise, Postural control, Anxiety
- Medical subject headings
- Parkinson Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise with Blood Flow RestrictionBehavioural
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 RestrictionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise with Blood Flow Restriction | Experimental | Participants perform an aerobic exercise session combined with blood flow restriction Receives: Behavioral: Aerobic Exercise with Blood Flow Restriction |
| Aerobic Exercise without Blood Flow Restriction | Active comparator | Participants perform the same aerobic exercise session without blood flow restriction Receives: Behavioral: Aerobic Exercise without Blood Flow Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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 (2)
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start28 Sep 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng-Ya Huang, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831980
- Sponsor's protocol ID
- A-BR-115-063-T
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07831980
- Acronym / sponsor ID
- A-BR-115-063-T
- Conditions
- Parkinson's Disease (PD), Anxiety, Postural Balance
- Keywords
- Blood Flow Restriction, Parkinson's Disease (PD), Aerobic exercise, Postural control, Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise with Blood Flow Restriction | Experimental | Behavioral: Aerobic Exercise with Blood Flow RestrictionParticipants perform an aerobic exercise session combined with blood flow restriction |
| Aerobic Exercise without Blood Flow Restriction | Active comparator | Behavioral: Aerobic Exercise without Blood Flow RestrictionParticipants perform the same aerobic exercise session without blood flow restriction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise with Blood Flow RestrictionThe 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. | Behavioural | Aerobic Exercise with Blood Flow Restriction |
| Aerobic Exercise without Blood Flow RestrictionParticipants 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. | Behavioural | Aerobic Exercise without Blood Flow Restriction |
Primary outcome
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.
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.
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.
2 secondary outcomes
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise with Blood Flow Restriction and Aerobic Exercise without Blood Flow Restriction in people with Parkinson's Disease (PD) and Anxiety, run by National Cheng-Kung University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheng-Ya Huang (886-6-2353535 ext. 5022, rcyhuang@gs.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.