Low-load Resistance Training With Blood Flow Restriction in People With Parkinson's Disease

NCT05806775 | Completed

• 1 other identifier: 22-2333
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study's objective is to determine the feasibility of low-load resistance training with blood flow restriction in people who have advanced Parkinson's disease and impaired mobility using a mixed-methods convergent parallel design in a single cohort. The study's long-term goal is to develop clinically feasible exercise interventions that are effective at improving mobility, participation, and quality of life for people with advanced Parkinson's disease.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Blood Flow Restriction; Low-load resistance training

Outcome Measures

Primary Outcomes (3)

• Change in Knee Extension

  Knee extension muscle strength measured using fixed myometry (QMA Muscle Testing System)

  Measured at Baseline (Week 0) and Post Test (Week 9)

• Change in Ankle Plantarflexion

  Ankle plantarflexion muscle strength measured using fixed myometry (QMA Muscle Testing System)

  Measured at Baseline (Week 0) and Post Test (Week 9)

• Change in Elbow Extension

  Elbow extension muscle strength measured using fixed myometry (QMA Muscle Testing System)

  Measured at Baseline (Week 0) and Post Test (Week 9)

Secondary Outcomes (4)

• Change in 30-second Sit-to-stand Completions

  Measured at Baseline (Week 0) and Post Test (Week 9)

• Change in Timed Up and Go Time

  Measured at Baseline (Week 0) and Post Test (Week 9)

• Change in Self-Selected Walking Speed

  Measured at Baseline (Week 0) and Post Test (Week 9)

• Change in Berg Balance Scale

  Measured at Baseline (Week 0) and Post Test (Week 9)

Other Outcomes (2)

• Change in Step Count

  Measured at Baseline (Week 0) and Post Test (Week 9)

• Change in Parkinson's Disease Questionnaire-39 Score

  Measured at Baseline (Week 0) and Post Test (Week 9)

Study Arms (1)

Low-load resistance training with blood flow restriction

EXPERIMENTAL

Exercises will target bilateral 1) knee extensor, 2) ankle plantarflexor, and 3) elbow extensor muscles. Exercises will be dosed based on 1RM and individualized for each participant from a standardized exercise set. Progression will be based on 1) body position (supine, seated, standing), and 2) degree of resistance. Dosing will be re-assessed every 2 weeks and progressed as tolerated. Resistance will be provided by the Shuttle Mini-Press (Shuttle Systems), a portable resistance trainer that allows for precise dosing but is also adaptable to people with mobility limitations.

Behavioral: Low-load resistance training with blood flow restriction

Interventions

Low-load resistance training with blood flow restriction BEHAVIORAL

A licensed physical therapist, will deliver intervention to all participants (2x/wk, 8 wks) using an FDA-cleared BFR system, the Delfi PTSII (Delfi Medical Innovations). The pressure cuff will be placed at the most proximal portion of the limb and dosed following standard BFR guidelines: 1 set of 30 reps, then 3 sets of 15 reps at 20-30% 1RM with a minimum of 60% and a maximum of 80% limb occlusion pressure. At 60-80% limb occlusion pressure there is diminished venous outflow to induce the necessary metabolic effect while still allowing arterial flow for safety. Individual limb occlusion pressures will be determined at the beginning of each session automatically by the Delfi PTSII device.

Low-load resistance training with blood flow restriction

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ages 18-89 with neurologist-confirmed diagnosis of PD
• H\&Y Stage 2 (bilateral involvement without postural instability) up to H\&Y Stage 4 (severe disease)
• Able to provide informed consent

You may not qualify if:

• H\&Y Stage 1 (unilateral involvement only) or less
• H\&Y Stage 5 (wheelchair or bed bound)
• Unable to provide consent or diagnosis of dementia
• History of deep venous thrombosis/pulmonary embolism, peripheral vascular disease, thrombophilia or other clotting disorders; report of easy bruising
• Any comorbid conditions or pain that substantially affects ability to safely complete rehabilitation (e.g. neurologic, vascular, cardiac problems, orthopedic, or ongoing medical treatments) as determined by a neurologist or physical therapist
• Currently undergoing supervised resistance training with a physical therapist or other exercise professional
• Using Blood Flow Restriction currently or in the previous 3 months prior to enrollment
• Cannot tolerate BFR pressure cuff inflated to 60% of total limb occlusion pressure during baseline assessment
• PD-related medication change in the month prior to enrollment

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Davis Phinney Foundation: collaborator

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 10, 2023
• Study Start: April 1, 2023
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2024
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)