Phase 2
N=13
Creatine Use and Muscle Stretching in Peripheral Artery Disease
Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT04471792 ↗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
| Outcome | Result | p-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
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.