Creatine Supplementation in Patients With Intermittent Claudication.

State University of Maringá

Status: Unknown

Conditions: Intermittent Claudication

Treatments: Dietary Supplement: Creatine; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02993874

Creatine PAD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

Creatine

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Creatine

Placebo

Placebo Comparator group

Description:

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)

Treatment:

Dietary Supplement: Placebo