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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Parkinson Disease

Treatments: Behavioral: Low-load resistance training with blood flow restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT05806775

22-2333

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Low-load resistance training with blood flow restriction

Experimental group

Description:

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.

Treatment:

Behavioral: Low-load resistance training with blood flow restriction