Creatine Supplementation in Patients With Intermittent Claudication.
- Conditions
- Intermittent Claudication
- Interventions
- Dietary Supplement: CreatineDietary Supplement: Placebo
- Registration Number
- NCT02993874
- Lead Sponsor
- State University of Maringá
- Brief Summary
The aim of this study will be to verify the effect of creatine supplementation associated to clinical treatment of the functional capacity in patients with intermittent claudication.
- Detailed Description
The aim of this study will be to verify the effect of creatine supplementation associated to clinical treatment of the functional capacity in patients with intermittent claudication. The sample will be composed by patients with intermittent claudication of both sexes. The patients will be ramdomized in a double-blind procedure to receive during seven days (loading) and posteriorly 49 days (maintenance) a creatine (Cr) supplementation or placebo (PLA), associated to the clinical treatment. Before ("baseline"), after "loading" period and after the maintenance period of supplementation, the patients will go through a functional capacity evaluation. The fuctional capacity evaluation will be evaluated by a six minute-walking test. For statistical analysis it will be used the ANOVA of two factors for repeated measurements, having the (Cr and PLA) group and the time (pre, post-loading and post-maintenance), and when needed the post-hoc of Newman keuls. The adopted level of significance will be P\<0.05.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- symptom of pain during the six-minute walk test limited by leg pain due to intermittent claudication.
- present peripheral artery disease (Ankle-arm index < 0.90) in one or both limbs.
- Asymptomatic intermittent claudication determined from the clinical history.
- Not have muscle or joint injuries that make it impossible to practice physical activity.
- not attending more than 15% of the intervention sessions or visits to the laboratory.
- Stick to a physical activity program in addition to that offered by the study.
- do not use medication regularly.
- aggravation of the disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Creatine Creatine Creatine monohydrate (Cr) Loading - 4 doses of 5g / day for 7 days Maintenance - 1 dose of 3g / day for 49 days Clinical treatment (30-45 minutes of walking, 3 times per week) Placebo Placebo Dextrose Loading - 4 doses of 5g / day for 7 days Maintenance - 1 dose of 3g / day for 49 days Clinical treatment (30-45 minutes of walking, 3 times per week)
- Primary Outcome Measures
Name Time Method Change walking capacity Baseline, one and eight weeks The walking capacity will be assessed through a six-minute walk test, before and after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).
- Secondary Outcome Measures
Name Time Method Change oxygen saturation Baseline, one and eight weeks Oxygen saturation will be assessed on calf region during the six-minute walk test through Near-infrared spectroscopy (NIRS, PortaMon, Artinis Medical Systems) before, after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).
Change Short Physical Performance Battery Baseline, one and eight weeks Functional capacity will be assessed through a Short Physical Performance Battery test, after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).
Change cognitive function Baseline, one and eight weeks For cognitive aspetcs evaluation the following procedures will be taken: Stroop test (Victoria Stroop test and N-Back (Operational Memory) will performed after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).
Trial Locations
- Locations (1)
Israel Institute of Education and Research Albert Einstein
🇧🇷Sao Paulo, Brazil