Effect of Creatine Supplementation Associated to Clinical Treatment of the Functional Capacity of Patients With Intermittent Claudication.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change walking capacity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Placebo (Dietary Supplement)
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)
干预措施: Creatine (Dietary Supplement)
结局指标
主要结局
Change walking capacity
时间窗: 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).
次要结局
- Change oxygen saturation(Baseline, one and eight weeks)
- Change Short Physical Performance Battery(Baseline, one and eight weeks)
- Change cognitive function(Baseline, one and eight weeks)
研究者
Ademar Avelar de Almeida Junior
PhD
State University of Maringá