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Phase 2 N=13 Randomized Single-blind Treatment

Creatine Use and Muscle Stretching in Peripheral Artery Disease

Peripheral Arterial Disease

Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Walking Distance — 375; 411; 405; 425 meters — p=0.38

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Creatine monohydrate (Drug); Cellulose (Dietary_supplement)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Florida State University
Primary completion
Dec 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Walking Distance
375; 411; 405; 425 0.38
SECONDARY
Change in Percent Oxygenation/Seconds
0.59; 0.59; 0.64; 0.67 0.883

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.

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04471792). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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