Static Muscular Stretching for Treatment of Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in Total Walking Distance
研究概览
简要总结
Patients with peripheral arterial disease (PAD) often have walking impairment due to insufficient oxygen supply to skeletal muscle. The investigator's pilot study in PAD patients has shown that endothelial function and walking distance improve with regular static muscle stretching. Therefore, the purpose of this study is to determine whether prescriptive muscle stretching improves muscle oxygenation and walking ability in PAD patients. This is a single-blinded study in 40 patients with stable symptomatic PAD. Patients assigned to the stretch group will use ankle splints (both legs) to perform static muscle stretching for 4 weeks (ankle dorsiflexion applied 30 min/d, 5 days/wk). Patients assigned to the control group will also wear the ankle splints daily but without invoking any dorsiflexion, i.e., without stretching. Measurements will consist of ankle-brachial index (ABI) at rest and post-exercise, skeletal muscle oxygenation (evaluated with near-infrared spectroscopy (NIRS)), and 6 minute walk test (6MWT), performed at baseline and after 4 weeks of stretching (or control splint placement). In addition, NIRS will be used to evaluate muscle oxygenation while patients are wearing the splint device in order to quantitatively prescribe the angle of dorsiflexion that provides optimum stretch and deoxygenation of the calf muscles without causing pain. Primary outcomes include increased muscle oxygenation during exercise and walking distance after 4 weeks of static muscle stretching. Results from this study will be used to support funding applications for a larger efficacy trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A resting ankle-brachial index (ABI) of 0.90 or less in either leg
- •Stable disease (PAD) for a minimum of 3-months
排除标准
- •Habitual exercise (30 minutes of continuous activity for 3 or more days per week)
- •Cardiovascular rehabilitation program during the past 3 months
- •Below or above-knee amputation, critical limb ischemia (ulceration or gangrene)
- •Leg pain at rest
- •Cardiorespiratory disease
- •Major surgery or lower extremity revascularization during the previous 3 months
- •Major medical illness treatment during the prior 12 months
- •Central neurological disease
- •Limited ankle or knee joint range of motion
- •Requirement of oxygen with activity or exercise
- •More than a class II New York Heart Association level of heart failure
- •Wheelchair confinement, or inability to walk
- •Cognitive disorder
- •Vasculitis problem including Takayasu's arteritis, Buerger's disease, collagen disease or Raynaud's disease
研究组 & 干预措施
Stretch Group
Subjects assigned to this group will be instructed on how to wear the device to produce the appropriate amount of dorsiflexion (stretch). Splint devices will be worn at the assigned angle 5 days/week, 30 minutes/day, for 4 weeks. ABI, muscle oxygenation, and walking distance will be assessed pre/post stretching. Other health surveys will be administered.
干预措施: Ankle Splint (Device)
No Stretch Group
Subjects assigned to this group will wear the splints but instructed to wear the device in a position that produces no stretch. Splint devices will be worn at the assigned angle 5 days/week, 30 minutes/day, for 4 weeks. ABI, muscle oxygenation, and walking distance will be assessed pre/post stretching. Other health surveys will be administered.
干预措施: Ankle Splint (Device)
结局指标
主要结局
Change in Total Walking Distance
时间窗: 4 weeks
Assessed by 6-minute walking test
Change in Muscle Oxygenation
时间窗: 4 weeks
Noninvasive assessment via NIRS monitor
Change in Continuous Walking Distance
时间窗: 4 weeks
Assessed by 6-minute walking test
次要结局
未报告次要终点
研究者
Emily Pritchard
PI
Florida State University
