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.
| 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 |
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
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.
| 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 |
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
Randomized, double-masked, parallel-group, 2-arm study
| Arm | Intervention | Description |
|-----|--------------|-------------|
| Experimental | BFR + IRT | Blood Flow Restriction combined with Instability Resistance Training |
| Control | IRT Only | Instability Resistance Training alone |
| Measure | Description | Target |
|---------|-------------|--------|
| Feasibility | Dropout rate and adverse event rate | <20% |
| 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 |
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.
BFR has demonstrated a strong safety profile in various populations when:
Instability Resistance Training involves performing resistance exercises on unstable surfaces or with unstable implements, challenging balance and proprioception alongside strength development.
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:
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 |
The accumulation of [alpha-synuclein](/proteins/alpha-synuclein) in Parkinson's disease affects multiple systems crucial for balance:
The [dopaminergic](/proteins/dopamine) system plays a critical role in postural control:
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 |
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 |
| 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 |
From the [SciDEX Exchange](/exchange) — scored by multi-agent debate
Related Analyses: