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Completed

NCT Number: NCT04471792

Creatine Use and Muscle Stretching in Peripheral Artery Disease

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.

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Key information

Age range

40 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Florida State University

Tallahassee, Florida, 32304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Creatine monohydrate

Drug

Creatine monohydrate will be used in combination with muscle stretching.

Cellulose

Dietary Supplement

Cellulose will be used in combination with muscle stretching.

Primary outcomes

  1. Walking Distance

    Time frame: 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.

Secondary outcomes

  1. Change in Percent Oxygenation/Seconds

    Time frame: Baseline and after 4 weeks of intervention

    Near-infrared spectroscopy (NIRS) will be used to measure changes in oxygen saturation (%) in the gastrocnemius muscle. Measurement will be the rate (slope) of the change in oxygen saturation (StO2) per second. Thus rate of rate in oxygenation (slope) = StO2(%)/s = Δ StO2(%)/s

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

Creatine Monohydrate Use and Muscle Stretching in Peripheral Artery Disease

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 15, 2020
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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