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临床试验/NCT04471792
NCT04471792已完成2 期

Creatine Monohydrate Use and Muscle Stretching in Peripheral Artery Disease

Florida State University1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2020年5月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
13
试验地点
1
主要终点
Walking Distance

研究概览

简要总结

To utilize near-infrared spectroscopy to investigate if the research device, which induces muscle stretching, and creatine loading impact submaximal exercise performance in aged and PAD patients. Near-infrared spectroscopy (NIRS)-derived tissue oxygenation responses will be obtained during device placement (muscle stretch) and during a walking test (i.e., six-minute walk test). Muscle oxygenation at rest and during device placement will be assessed with Magnetic Resonance Imaging. It is hypothesized that the stretching protocol will improve both NIRS-derived tissue oxygenation and magnetic resonance-derived muscle oxygenation and that creatine supplementation will further improve phosphorus metabolite muscle performance. All patients will undergo either 4 weeks of stretch training with- or- without creatine supplementation according to previously defined creatine guidelines.

详细描述

Lower extremity peripheral artery disease (PAD) has been estimated to impact nearly 8.5 million U.S. adults above the age of 40, significantly increasing the rate of morbidity and mortality with concomitant decreases in quality of life. These patients are often given medical therapy (e.g., statins, antiplatelet, anticoagulants) and are also recommended to begin structured exercise programs. However, the limb ischemia that occurs during physical activity in these patients often limits exercise tolerance. A previous study by Bauer and colleagues showed that impaired muscle metabolism is a major contributor to functional limitations in PAD patients. These data are important in that they show alterations in blood flow and metabolic machinery likely impact exercise tolerance. As such, the development of tolerable countermeasures to improve limb blood flow and muscle energetics may increase adherence to exercise therapy and improve health outcomes in PAD patients. Previous work by the investigators has shown that daily muscle stretching, achieved via 30-minutes of ankle dorsiflexion, significantly improved soleus muscle function and muscle blood flow during exercise in a rat model of aging . In a follow-up study, the investigators have also shown that this model improves vascular function and walking function in PAD patients. As noted above, muscle energetics are delayed in PAD patients, so improving the rest-to-exercise transition with creatine supplementation may help PAD patients sustain exercise longer. The investigators are now testing to see if an added supplement can further improve the effects of muscle stretching in PAD patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Randomized, single-blind research design.

入排标准

年龄范围
40 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ankle-brachial index (ABI) of 0.90 or less in either leg or clinical diagnosis by a medical doctor (PAD group only)
  • Stable condition for at least 3 months (PAD group only)

排除标准

  • Habitual exercise or cardiovascular rehabilitation program during the past 3 months
  • Critical limb ischemia
  • Blow or above-knee amputation
  • Leg pain at rest
  • Major surgery or lower extremity revascularization in the last 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
  • Heart failure
  • Atrial fibrillation
  • Wheelchair confinement or inability to walk
  • Cognitive disorder
  • Vasculitis problems including Takayasu's arteritis, Berger's disease, collagen disease or Reynaud's disease
  • Overt cardiovascular disease
  • Metabolic disease
  • Renal disease

研究组 & 干预措施

Creatine monohydrate

Experimental

Creatine Monohydrate will be given at a 5 day loading period (10g/day) followed by a maintenance phase (5 g/day). The objectives of the current trial are to investigate if creatine supplementation plus muscle stretching improves 6-minute walking distance and muscle oxygenation in patients with peripheral artery disease.

干预措施: Creatine monohydrate (Drug)

Cellulose

Placebo Comparator

These participants will consume a fiber supplement in place of creatine monohydrate at a matched dose with muscle stretching.

干预措施: Cellulose (Dietary Supplement)

结局指标

主要结局

Walking Distance

时间窗: Baseline and after 4 weeks of intervention

6-minute walking test. This test measures the distance (in meters) that a patient can walk in 6 minutes.

次要结局

  • Change in Percent Oxygenation/Seconds(Baseline and after 4 weeks of intervention)

研究者

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

Judy Delp

Professor

Florida State University

研究点 (1)

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