Low-load Resistance Training With Blood Flow Restriction in People With Parkinson's Disease (BFR-PD)

Feasibility of Low-load Resistance Training With Blood Flow Restriction in People With Advanced Disability Due to Parkinson's Disease

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Low-load resistance training with blood flow restriction

Detailed Description

This study will use a mixed-methods convergent parallel design to determine the feasibility of low-load BFR training in 20 people with advanced PD symptoms and impaired mobility (Hoehn and Yahr Stage [H&Y] 3-4). All participants will receive low intensity resistance training (20-30% of 1RM) with BFR targeting knee extensor, ankle plantarflexor, and elbow extensor muscles 2x/week for 8 weeks. Intervention will be delivered by a physical therapist with specialized training in BFR. Pre-defined feasibility criteria will be assessed in the primary aim. Outcomes assessed before and immediately after the 8-week intervention will include quantitative muscle strength and mobility assessments, and quantitative and qualitative data on health-related QOL.

Aim 1: Determine low-load BFR training feasibility based on the following quantitative and qualitative criteria: 1) enrolling 20 participants, 2) retaining ≥80% participants, 3) obtaining ≥80% intervention adherence, 4) having no serious intervention-related adverse events, and 5) quantitatively and qualitatively measured acceptability.

Aim 2: Determine changes in 1) knee extensor, ankle plantarflexor, and elbow extensor muscle strength using fixed myometry and 2) instrumented functional mobility (30-second Sit-to-Stand, Timed up and Go, self-selected walking speed, and Berg Balance Scale) using a system of inertial measurement unit wearable sensors.

Exploratory Aim: Understand health-related QOL changes using the Parkinson's Disease Questionnaire-39 (PDQ-39) and semi-structured interviews to elucidate how components of the intervention translate into QOL changes through a mixed-method analysis of PDQ-39 constructs of mobility, activities of daily living, emotional well-being, social stigma, social support, cognition, communications, and bodily discomfort.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Low-load resistance training with blood flow restriction; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 30-second Sit-to-stand Completions	Functional mobility test measuring the number of sit to stand cycles a participant can complete in 30 seconds	Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Timed Up and Go Time	Functional mobility test measuring the time required to stand from sitting, walk 10 feet, turn and return to seated position at starting point	Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Self-Selected Walking Speed	Gait speed measured over a 10-meter walking course, measured in seconds	Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Berg Balance Scale	Functional mobility test measuring the participant's ability to balance in different postures. Scores on the Berg Balance Scale range from 0 to 56 points, with 0-20 points indicating wheelchair bound, 21-40 indicating walking with assistance, and 41-56 indicating walking independently.	Measured at Baseline (Week 0) and Post Test (Week 9)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Step Count	10-day average step count as measured by a wearable activity monitor	Measured at Baseline (Week 0) and Post Test (Week 9)
Change in Parkinson's Disease Questionnaire-39 Score	39 item questionnaire measuring quality of life in people with Parkinson's disease. Scores range from 0 to 100 with lower scores indicating higher quality of life	Measured at Baseline (Week 0) and Post Test (Week 9)

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Davis Phinney Foundation

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): November 8, 2024
• Study Completion (Actual): November 8, 2024

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Parkinson Disease; Blood Flow Restriction; Low-load resistance training
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 22-2333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No