- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04471792
Creatine Use and Muscle Stretching in Peripheral Artery Disease
February 11, 2023 updated by: Judy Delp, Florida State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Matthew Martenson, MS MPH
- Phone Number: (706) 296-1855
- Email: msm17b@my.fsu.edu
Study Contact Backup
- Name: Jacob Caldwell, Ph.D.
- Phone Number: 248-469-2058
- Email: jacob.caldwell@med.fsu.edu
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32304
- Florida State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 95 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Creatine monohydrate
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.
|
Creatine monohydrate will be used in combination with muscle stretching.
|
PLACEBO_COMPARATOR: Cellulose
These participants will consume a fiber supplement in place of creatine monohydrate at a matched dose with muscle stretching.
|
Cellulose will be used in combination with muscle stretching.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Walking tolerance
Time Frame: 4 weeks
|
All patients will perform a pre -and -post 6 minute walking test to assess functional outcomes of muscle stretching and supplementation
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Near infrared spectroscopy (NIRS)
Time Frame: 4 weeks
|
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
|
Magnetic Resonance Imaging (MRI)
Time Frame: 4 weeks
|
Use of MRI to assess muscle oxygenation during a vascular occlusion test at rest, and during placement of splint device
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Judy Muller-Delp, Ph.D., Professor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 12, 2020
Primary Completion (ACTUAL)
December 15, 2022
Study Completion (ACTUAL)
December 15, 2022
Study Registration Dates
First Submitted
June 20, 2020
First Submitted That Met QC Criteria
July 13, 2020
First Posted (ACTUAL)
July 15, 2020
Study Record Updates
Last Update Posted (ESTIMATE)
February 14, 2023
Last Update Submitted That Met QC Criteria
February 11, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1150
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Arterial Disease
-
University of NebraskaNot yet recruitingPeripheral Arterial Disease | Peripheral Vascular Diseases | Peripheral Arterial Occlusive Disease | Peripheral Artery DiseaseUnited States
-
CID S.p.A.Meditrial Europe Ltd.Not yet recruitingPeripheral Arterial Occlusive Disease | Peripheral Artery DiseaseItaly
-
Marissa JarosinskiRecruitingPeripheral Arterial Occlusive Disease | Peripheral Vascular Disease | Peripheral Artery Disease | Clopidogrel, Poor Metabolism of | Artery DiseaseUnited States
-
Stanford UniversityTerminatedPAD - Peripheral Arterial Disease | PVD- Peripheral Vascular DiseaseUnited States
-
Vascuros Medical Pte LtdNovella ClinicalUnknownPeripheral Arterial Occlusive Disease | Peripheral Vascular Disease | Peripheral Artery DiseaseSingapore, Belgium, Germany
-
Western Vascular Institute, IrelandRecruitingPeripheral Arterial Occlusive DiseaseIreland
-
Jena University HospitalAngioDroid s.r.l., Bologna (Italy)CompletedPeripheral Arterial Occlusive DiseaseGermany
-
Seoul National University HospitalAstellas Pharma Korea, Inc.CompletedPeripheral Arterial Occlusive DiseaseKorea, Republic of
-
Heidelberg UniversityTerminatedPeripheral Arterial Occlusive DiseaseGermany
-
Johann Wolfgang Goethe University HospitalSuspendedPeripheral Arterial Occlusive DiseaseGermany
Clinical Trials on Creatine monohydrate
-
Texas A&M UniversityNutraboltCompletedDietary Modification
-
Texas A&M UniversityNutraboltCompletedDietary Supplementation
-
Massachusetts General HospitalCompletedHuntington's Disease (HD)United States
-
Dynamical Business and Science Society - DBSS International...CES University; INDEPORTES AntioquiaCompleted
-
The Cleveland ClinicCompletedHypercholesterolemia | Weakness | Cramps | AchesUnited States
-
Perry RenshawCompletedMajor Depressive DisorderUnited States
-
University of UtahNational Cancer Institute (NCI)RecruitingFatigue | Sedentary Lifestyle | Metastatic Prostate Carcinoma | Stage IV Prostate Cancer AJCC (American Joint Committee on Cancer) v8 | Stage IVA Prostate Cancer AJCC (American Joint Committee on Cancer) v8 | Stage IVB Prostate Cancer AJCC (American Joint Committee on Cancer) v8United States
-
Beth Israel Medical CenterCompleted
-
Psychiatric Research Unit, Region Zealand, DenmarkUniversity of Southern DenmarkNot yet recruitingMild Traumatic Brain Injury | Concussion, Brain
-
University of UtahRecruitingMajor Depressive DisorderUnited States