Creatine Use and Muscle Stretching in Peripheral Artery Disease
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Creatine monohydrate; Cellulose
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Creatine monohydrate will be used in combination with muscle stretching.; Cellulose will be used in combination with muscle stretching.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Muscle stretch; Creatine Monohydrate