Peripheral Arterial DiseasePhase 2NCT04471792
Creatine Use and Muscle Stretching in Peripheral Artery Disease
A Phase 2 study testing Creatine monohydrate and Cellulose in people with Peripheral Arterial Disease, run by Florida State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Creatine monohydrate and Cellulose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2020to 15 Dec 2022
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32304
About this study
Official title: Creatine Monohydrate 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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Creatine monohydrate, Cellulose
- Keywords
- Muscle stretch, Creatine Monohydrate
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine monohydrateDrug
Creatine monohydrate will be used in combination with muscle stretching.
CelluloseDietary supplement
Cellulose will be used in combination with muscle stretching.
| Study group | Role | What they receive |
|---|---|---|
| Creatine monohydrate | Experimental | Creatine Monohydrate will be given at a 5 day loading period (10g/day) followed by a maintenance phase (5 g/day). The objectives of the current trial are to investigate if creatine supplementation plus muscle stretching improves 6-minute walking distance and muscle oxygenation in patients with peripheral artery disease. Receives: Drug: Creatine monohydrate |
| Cellulose | Placebo comparator | These participants will consume a fiber supplement in place of creatine monohydrate at a matched dose with muscle stretching. Receives: Dietary Supplement: Cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Distance
6-minute walking test. This test measures the distance (in meters) that a patient can walk in 6 minutes.
Measured: Baseline and after 4 weeks of intervention
Secondary outcomes (1)
Change in Percent Oxygenation/Seconds
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
Measured: Baseline and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start12 May 2020
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judy Delp, Florida State University
- Investigators
- Judy Muller-Delp, Ph.D., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471792
- Sponsor's protocol ID
- 1150
- Status last verified
- Nov 2025
- First submitted
- 20 Jun 2020
- Last updated
- 8 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hultman E, Soderlund K, Timmons JA, Cederblad G, Greenhaff PL. Muscle creatine loading in men. J Appl Physiol (1985). 1996 Jul;81(1):232-7. doi: 10.1152/jappl.1996.81.1.232.
PubMed 8828669Hotta K, Behnke BJ, Arjmandi B, Ghosh P, Chen B, Brooks R, Maraj JJ, Elam ML, Maher P, Kurien D, Churchill A, Sepulveda JL, Kabolowsky MB, Christou DD, Muller-Delp JM. Daily muscle stretching enhances blood flow, endothelial function, capillarity, vascular volume and connectivity in aged skeletal muscle. J Physiol. 2018 May 15;596(10):1903-1917. doi: 10.1113/JP275459. Epub 2018 Apr 5.
PubMed 29623692