Clinical trial NCT05806775: Low-load Resistance Training With Blood Flow Restriction in People With Parkinson's Disease
Official title: Feasibility of Low-load Resistance Training With Blood Flow Restriction in People With Advanced Disability Due to Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Blood Flow Restriction
Low-load resistance training
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Davis Phinney Foundation
First posted: 2023-04-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Knee Extension
timeFrame: Measured at Baseline (Week 0) and Post Test (Week 9)
measure: Change in Ankle Plantarflexion
timeFrame: Measured at Baseline (Week 0) and Post Test (Week 9)
measure: Change in Elbow Extension
timeFrame: Measured at Baseline (Week 0) and Post Test (Week 9)
Secondary outcomes:
measure: Change in 30-second Sit-to-stand Completions
timeFrame: Measured at Baseline (Week 0) and Post Test (Week 9)
measure: Change in Timed Up and Go Time
timeFrame: Measured at Baseline (Week 0) and Post Test (Week 9)
measure: Change in Self-Selected Walking Speed
timeFrame: Measured at Baseline (Week 0) and Post Test (Week 9)
measure: Change in Berg Balance Scale
timeFrame: Measured at Baseline (Week 0) and Post Test (Week 9)
Other outcomes:
measure: Change in Step Count
timeFrame: Measured at Baseline (Week 0) and Post Test (Week 9)
measure: Change in Parkinson's Disease Questionnaire-39 Score
timeFrame: Measured at Baseline (Week 0) and Post Test (Week 9)
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
References: