Creatine Use and Muscle Stretching in Peripheral Artery Disease

Completed · Phase 2

Conditions studied: Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT04471792

Run by

Florida State University

People needed

13

Starts

2020-05-12

Expected to finish

2022-12-15

Last updated by the study team

2025-12-08

Who can join

Age: 40 and older, up to 95. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Florida State University — Tallahassee, Florida, United States

Full record on ClinicalTrials.gov

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