Creatine Use and Muscle Stretching in Peripheral Artery Disease

NCT04471792 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 1150
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Arterial Disease

Keywords

Muscle stretch; Creatine Monohydrate

Outcome Measures

Primary Outcomes (1)

• Walking Distance

  6-minute walking test. This test measures the distance (in meters) that a patient can walk in 6 minutes.

  Baseline and after 4 weeks of intervention

Secondary Outcomes (1)

• Change in Percent Oxygenation/Seconds

  Baseline and after 4 weeks of intervention

Study Arms (2)

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.

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.

Dietary Supplement: Cellulose

Interventions

Cellulose DIETARY_SUPPLEMENT

Cellulose will be used in combination with muscle stretching.

Cellulose

Creatine monohydrate DRUG

Creatine monohydrate will be used in combination with muscle stretching.

Creatine monohydrate

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32304, United States

Location

Related Publications (2)

• 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.

  PMID: 8828669 BACKGROUND

• 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.

  PMID: 29623692 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Creatine; Cellulose

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Judy Delp
• Organization: Kansas State University

mullerdelp@vet.k-state.edu

3522269535

Study Officials

• Judy Muller-Delp, Ph.D.

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomized, single-blind research design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: July 15, 2020
• Study Start: May 12, 2020
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: December 8, 2025
• Results First Posted: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)