Feasibility of Low-load Resistance Training With Blood Flow Restriction in People With Advanced Disability Due to Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Knee Extension
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Knee Extension
时间窗: Measured at Baseline (Week 0) and Post Test (Week 9)
Knee extension muscle strength measured using fixed myometry (QMA Muscle Testing System)
Change in Ankle Plantarflexion
时间窗: Measured at Baseline (Week 0) and Post Test (Week 9)
Ankle plantarflexion muscle strength measured using fixed myometry (QMA Muscle Testing System)
Change in Elbow Extension
时间窗: Measured at Baseline (Week 0) and Post Test (Week 9)
Elbow extension muscle strength measured using fixed myometry (QMA Muscle Testing System)
次要结局
- 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 30-second Sit-to-stand Completions(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))