Feasibility of Low-load Resistance Training Using Blood Flow Restriction for People With Multiple Sclerosis and Marked Mobility Restriction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Knee Extension Muscle Strength (More-involved Side)
研究概览
简要总结
The Primary Aim of this research study is to determine the feasibility of 8 weeks of physical therapy strengthening exercises using blood flow restriction (BFR) in people with multiple sclerosis (MS) who have moderate-to-severe walking problems. BFR training involves placing a cuff on the leg being exercised in order to restrict blood flow. The cuff is attached to a specialized device that automatically detects the appropriate amount of pressure to place on the limb. Testing will occur before and after the 8-week treatment period.
详细描述
The Primary Aim of this research study is to determine the feasibility of 8 weeks of physical therapy strengthening exercises using blood flow restriction (BFR) in people with multiple sclerosis (MS) who have moderate-to-severe walking problems. BFR training involves placing a cuff on the leg being exercised in order to restrict blood flow. The cuff is attached to a specialized device that automatically detects the appropriate amount of pressure to place on the limb. Testing will occur before and after the 8-week treatment period.
Specific Aim 1: Determine the feasibility of BFR by assessing recruitment rate, retention, adherence, satisfaction, and safety.
Hypothesis: Feasibility will be demonstrated by: 1) enrolling 20 participants in 8 months, 2) retaining at least 16 (80%) participants, 3) 80% adherence to intervention, 4) 90% satisfaction with intervention, and 5) no serious adverse events related to the intervention.
Specific Aim 2: Determine changes in knee and hip extension, hip abduction, and ankle plantarflexion muscle strength after the 8-week intervention.
Hypothesis: Following intervention there will be clinically important within-group strength changes that correspond to established minimal detectable change values and which can be characterized as having at least a moderate effect size as defined by Cohen's d.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ages 18-70
- •Neurologist-confirmed diagnosis of multiple sclerosis
- •Expanded Disability Status Scale (EDSS) 6.0 to 7.0
- •EDSS 6.0: unilateral assistance (cane or crutch) required to walk at least 100 meters with or without resting
- •EDSS 6.5: Bilateral assistance (cane or crutch) required to walk at least 20 meters with or without resting
- •EDSS 7.0: unable to walk 5 meters even with aid, essentially restricted to wheelchair; wheels self and transfers alone; up and about in wheelchair some 12 hours a day
排除标准
- •EDSS 7.5 or greater: Restricted to wheelchair for all mobility, unable to walk more than a few steps, even with walking aid
- •EDSS 5.5 or less: Able to walk more than 100 meters without walking aid or rest
- •Unable to provide consent or follow simple directions
- •Prior history of Deep Venous Thrombosis/ Pulmonary Embolism
- •History of peripheral vascular disease, thrombophilia or other clotting disorders
- •Patient report of easy bruising
- •Any comorbid conditions or pain that substantially affects physical function or would interfere with the participant's ability to safely complete rehabilitation (e.g. neurologic, vascular, cardiac problems, orthopedic, or ongoing medical treatments) as determined by a neurologist of physical therapist
- •Severe lower extremity spasticity as defined as Modified Ashworth scale > 2
- •Currently undergoing supervised resistance training with a physical therapist or other exercise professional
- •Use of Blood Flow Restriction currently or in the previous 3 months prior to enrollment
- •MS-related exacerbation or changes to their disease-modifying drug therapy in the month prior to enrollment
- •Inability to tolerate pressure cuff during baseline assessment
研究组 & 干预措施
Blood Flow Restriction Exercise
Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks.
干预措施: Blood Flow Restriction Exercise (Other)
结局指标
主要结局
Change in Knee Extension Muscle Strength (More-involved Side)
时间窗: Measured at Baseline (Week 0) and Post Test (Week 9)
Knee extension muscle strength measured by hand-held dynamometry on the more-involved side. The more-involved limb was determined at baseline assessment and defined as the limb with worse muscle strength.
Change in Hip Abduction Muscle Strength (More-involved Side)
时间窗: Measured at Baseline (Week 0) and Post Test (Week 9)
Hip abduction muscle strength measured by hand-held dynamometry on the more-involved side. The more-involved limb was determined at baseline assessment and defined as the limb with worse muscle strength.
Change in Ankle Plantarflexion Muscle Strength (More-involved Side)
时间窗: Measured at Baseline (Week 0) and Post Test (Week 9)
Ankle plantarflexion muscle strength measured by hand-held dynamometry on the more-involved side. The more-involved limb was determined at baseline assessment and defined as the limb with worse muscle strength.
Change in Knee Extension Muscle Strength (Less-involved Side)
时间窗: Measured at Baseline (Week 0) and Post Test (Week 9)
Knee extension muscle strength measured by hand-held dynamometry on the less-involved side. The less-involved limb was determined at baseline assessment and defined as the limb with better muscle strength.
Change in Hip Abduction Muscle Strength (Less-involved Side)
时间窗: Measured at Baseline (Week 0) and Post Test (Week 9)
Hip abduction muscle strength measured by hand-held dynamometry on the less-involved side. The less-involved limb was determined at baseline assessment and defined as the limb with better muscle strength.
Change in Ankle Plantarflexion Muscle Strength (Less-involved Side)
时间窗: Measured at Baseline (Week 0) and Post Test (Week 9)
Ankle plantarflexion muscle strength measured by hand-held dynamometry on the less-involved side. The less-involved limb was determined at baseline assessment and defined as the limb with better muscle strength.
次要结局
- Change in 12-Item MS Walking Scale(Measured at Baseline (Week 0) and Post Test (Week 9))
- Change in Modified Fatigue Impact Scale(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))
- Change in MS Patient-Specific Function Scale(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 Timed 25-foot Walk(Measured at Baseline (Week 0) and Post Test (Week 9))
- Change in Activity Level(Measured at Baseline (Week 0) and Post Test (Week 9))