Blood Flow Restriction for Optimizing Balance in Parkinson's Disease (NCT06508801)

Overview

This clinical trial investigates the effects of Blood Flow Restriction (BFR) combined with Instability Resistance Training (IRT) on balance and motor function in patients with [Parkinson's Disease](/diseases/parkinsons-disease). The study is conducted at The University of Texas Health Science Center at San Antonio and represents a novel approach to addressing balance dysfunction in PD patients through low-load resistance training with blood flow restriction.

Trial Details

| Parameter | Value |
|-----------|-------|
| NCT Number | NCT06508801 |
| Title | Blood Flow Restriction for Optimizing Balance in Parkinson's Disease |
| Brief Title | BFR for PD Balance |
| Status | Recruiting |
| Phase | Not Applicable |
| Study Type | Interventional |
| Enrollment | 20 participants |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Collaborator | National Institute on Aging |
| Start Date | January 2025 |
| Completion Date | December 2026 |
| Location | San Antonio, Texas, United States |

Primary Investigator

Anjali Sivaramakrishnan, PhD, PT
Department of Physical Therapy
The University of Texas Health Science Center at San Antonio

Contact: (210) 567-8626 | sivaramakris@uthscsa.edu

Study Design

Design Type

Overview

This clinical trial investigates the effects of Blood Flow Restriction (BFR) combined with Instability Resistance Training (IRT) on balance and motor function in patients with [Parkinson's Disease](/diseases/parkinsons-disease). The study is conducted at The University of Texas Health Science Center at San Antonio and represents a novel approach to addressing balance dysfunction in PD patients through low-load resistance training with blood flow restriction.

Trial Details

| Parameter | Value |
|-----------|-------|
| NCT Number | NCT06508801 |
| Title | Blood Flow Restriction for Optimizing Balance in Parkinson's Disease |
| Brief Title | BFR for PD Balance |
| Status | Recruiting |
| Phase | Not Applicable |
| Study Type | Interventional |
| Enrollment | 20 participants |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Collaborator | National Institute on Aging |
| Start Date | January 2025 |
| Completion Date | December 2026 |
| Location | San Antonio, Texas, United States |

Primary Investigator

Anjali Sivaramakrishnan, PhD, PT
Department of Physical Therapy
The University of Texas Health Science Center at San Antonio

Contact: (210) 567-8626 | sivaramakris@uthscsa.edu

Study Design

Design Type

Randomized, double-masked, parallel-group, 2-arm study

Arms

| Arm | Intervention | Description |
|-----|--------------|-------------|
| Experimental | BFR + IRT | Blood Flow Restriction combined with Instability Resistance Training |
| Control | IRT Only | Instability Resistance Training alone |

Protocol

• Sessions: 2 sessions per week
• Duration: 6 weeks (12 total sessions)
• Blinding: Double-masked (participants and outcome assessors)

Eligibility Criteria

Inclusion Requirements

• Adults aged 40-85 years
• Diagnosis of idiopathic [Parkinson's Disease](/diseases/parkinsons-disease) (UK Brain Bank criteria)
• Hoehn & Yahr stage 2-4
• Mini-Mental State Examination (MMSE) score ≥23

Exclusion Criteria

• Cardiovascular disease
• Uncontrolled hypertension
• Uncontrolled diabetes
• Recent lower extremity surgery
• Other significant medical conditions affecting ability to participate

Outcome Measures

Primary Outcomes

| Measure | Description | Target |
|---------|-------------|--------|
| Feasibility | Dropout rate and adverse event rate | <20% |

Secondary Outcomes

| Measure | Domain | Assessment Tool |
|---------|--------|-----------------|
| Balance | Postural stability | miniBESTest |
| Mobility | Lower extremity function | 30-second chair stand test |
| Motor Severity | PD motor symptoms | MDS-UPDRS III |
| Postural Sway | Static balance | Postural sway measurement |
| Spinal Excitability | Neural function | H-reflex assessment |
| Lower Extremity Strength | Muscle strength | Hip abductors, knee extensors, ankle plantar flexors |

Scientific Rationale

Blood Flow Restriction (BFR) in Neurological Rehabilitation

Blood Flow Restriction (BFR) training is an innovative rehabilitation technique that combines low-load resistance exercise with brief periods of blood flow occlusion. This approach has gained recognition for its ability to induce muscle strength and size gains comparable to high-load resistance training, but with significantly lower mechanical stress.

Mechanism of Action

Safety Profile

BFR has demonstrated a strong safety profile in various populations when:

• Pressure is individualized to arterial occlusion pressure (AOP)
• Sessions are limited to short durations
• Appropriate exclusion criteria are applied

Instability Resistance Training (IRT)

Instability Resistance Training involves performing resistance exercises on unstable surfaces or with unstable implements, challenging balance and proprioception alongside strength development.

Benefits for Parkinson's Disease

• Proprioceptive Training: Improves position sense and kinesthetic awareness
• Balance Recovery: Challenges postural control systems
• Functional Transfer: Improvements translate to real-world functional activities
• Dual-Task Training: Combines motor and cognitive demands

Balance Dysfunction in Parkinson's Disease

Balance impairment is a cardinal feature of Parkinson's disease, contributing to falls, reduced mobility, and decreased quality of life. The dysfunction arises from multiple pathological mechanisms:

Neuroanatomical Contributions

Clinical manifestations

• Foam Postural Sway: Increased sway on compliant surfaces
• Pull Test Retraction: Delayed or absent corrective responses to backward displacement
• Freezing of Gait: Sudden motor blocks during walking
• Reduced Arm Swing: Bilateral coordination deficits

Rationale for BFR + IRT Combination

The combination of BFR with instability training addresses multiple aspects of balance dysfunction:

| Component | Target | Mechanism |
|----------|--------|-----------|
| BFR | Muscle strength | Low-load training with high metabolic stress |
| IRT | Balance/proprioception | Unstable surface training |
| Combined | Functional outcomes | Integrated motor and sensory challenges |

Connection to Parkinson's Disease Pathology

Alpha-Synuclein and Postural Control

The accumulation of [alpha-synuclein](/proteins/alpha-synuclein) in Parkinson's disease affects multiple systems crucial for balance:

• Basal Ganglia: Loss of dopaminergic neurons disrupts automatic postural responses
• Brainstem Nuclei: Red nucleus, pedunculopontine nucleus involvement
• Peripheral Nervous System: Autonomic dysfunction affects blood pressure regulation

dopaminergic Contributions

The [dopaminergic](/proteins/dopamine) system plays a critical role in postural control:

• Nigrostriatal Pathway: Loss of dopamine in the striatum affects automatic movement
• Mesocortical Pathway: Reduced cortical activation for voluntary postural adjustments
• Tuberoinfundibular Pathway: May affect hormonal responses to exercise

Exercise-Induced Neuroprotection

This trial contributes to the growing evidence base for exercise as disease-modifying intervention in PD:

| Mechanism | Evidence |
|-----------|----------|
| Neurotrophic factors | Increased BDNF expression |
| Alpha-synuclein clearance | Enhanced autophagy |
| Mitochondrial function | Improved complex I activity |
| Inflammation reduction | Decreased microglial activation |

Expected Outcomes

This trial aims to establish feasibility and preliminary efficacy of BFR combined with instability training for PD patients:

| Hypothesis | Expected Result |
|------------|-----------------|
| Feasibility | <20% dropout and adverse event rates |
| Balance | Improvement on miniBESTest |
| Mobility | Increased chair stand repetitions |
| Motor Severity | Reduction in MDS-UPDRS III scores |
| Strength | Increased lower extremity strength |

Comparison to Other PD Exercise Interventions

| Intervention | Evidence Level | Mechanism |
|-------------|----------------|-----------|
| BFR + IRT (NCT06508801) | Investigational | Blood flow restriction + instability training |
| LSVT BIG | Established | Amplitude-focused movement training |
| Tai Chi | Established | Balance and flexibility |
| Dance (PD Big) | Established | Rhythmic movement |
| Standard PT | Established | General exercise |

Related Pages

• [Parkinson's Disease](/diseases/parkinsons-disease)](/proteins/parkin)
• [Blood Flow Restriction Therapy](/entities/blood-flow-restriction)](/entities)
• [Alpha-Synuclein](/proteins/alpha-synuclein)](/proteins)
• [Dopaminergic Neurons](/cell-types/dopaminergic-neurons-snpc)](/entities/neurons)
• [Balance Disorders in Parkinson's Disease](/entities/balance-disorders-pd)

External Links

• [ClinicalTrials.gov - NCT06508801](https://clinicaltrials.gov/study/NCT06508801)
• [UT Health San Antonio](https://www.uthscsa.edu/)

References

Related Hypotheses

From the [SciDEX Exchange](/exchange) — scored by multi-agent debate

• [Synthetic Biology BBB Endothelial Cell Reprogramming](/hypothesis/h-84808267) — <span style="color:#81c784;font-weight:600">0.71</span> · Target: TFR1, LRP1, CAV1, ABCB1
• [Glymphatic System-Enhanced Antibody Clearance Reversal](/hypothesis/h-62e56eb9) — <span style="color:#81c784;font-weight:600">0.66</span> · Target: AQP4
• [Dual-Domain Antibodies with Engineered Fc-FcRn Affinity Modulation](/hypothesis/h-23a3cc07) — <span style="color:#ffd54f;font-weight:600">0.58</span> · Target: FCGRT
• [Circadian-Synchronized LRP1 Pathway Activation](/hypothesis/h-7e0b5ade) — <span style="color:#ffd54f;font-weight:600">0.57</span> · Target: LRP1, MTNR1A, MTNR1B
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• [Magnetosonic-Triggered Transferrin Receptor Clustering](/hypothesis/h-aa2d317c) — <span style="color:#ffd54f;font-weight:600">0.52</span> · Target: TFR1
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Related Analyses:

• [Blood-brain barrier transport mechanisms for antibody therapeutics](/analysis/SDA-2026-04-01-gap-008) &#x1f504;