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临床试验/NCT04222751
NCT04222751已完成不适用

Static Muscular Stretching for Treatment of Peripheral Artery Disease

Florida State University1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2020年7月29日最近更新:
适应症
干预措施

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

Experimental

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

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily Pritchard

PI

Florida State University

研究点 (1)

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