Peripheral Arterial Disease Clinical Trial
Official title:
Creatine Monohydrate Use and Muscle Stretching in Peripheral Artery Disease
NCT number | NCT04471792 |
Other study ID # | 1150 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 12, 2020 |
Est. completion date | December 15, 2022 |
Verified date | February 2023 |
Source | Florida State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | December 15, 2022 |
Est. primary completion date | December 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 95 Years |
Eligibility | Inclusion Criteria: 1. Ankle-brachial index (ABI) of 0.90 or less in either leg or clinical diagnosis by a medical doctor (PAD group only) 2. Stable condition for at least 3 months (PAD group only) Exclusion Criteria: 1. Habitual exercise or cardiovascular rehabilitation program during the past 3 months 2. Critical limb ischemia 3. Blow or above-knee amputation 4. Leg pain at rest 5. Major surgery or lower extremity revascularization in the last 3 months 6. Major medical illness treatment during the prior 12 months 7. Central neurological disease 8. Limited ankle or knee joint range of motion 9. Requirement of oxygen with activity or exercise 10. Heart failure 11. Atrial fibrillation 12. Wheelchair confinement or inability to walk 13. Cognitive disorder 14. Vasculitis problems including Takayasu's arteritis, Berger's disease, collagen disease or Reynaud's disease 15. Overt cardiovascular disease 16. Metabolic disease 17. Renal disease |
Country | Name | City | State |
---|---|---|---|
United States | Florida State University | Tallahassee | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida State University |
United States,
Hotta 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Walking tolerance | All patients will perform a pre -and -post 6 minute walking test to assess functional outcomes of muscle stretching and supplementation | 4 weeks | |
Secondary | Near infrared spectroscopy (NIRS) | Use of NIRS on the lateral head of the gastrocnemius muscle in all patients will be performed. NIRS will be measured during a vascular occlusion test, during placement of splint device, and the 6 minute walking test. | 4 weeks | |
Secondary | Magnetic Resonance Imaging (MRI) | Use of MRI to assess muscle oxygenation during a vascular occlusion test at rest, and during placement of splint device | 4 weeks |
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