Trial | NCT02993874  Report issue

Title

Creatine Supplementation in Patients With Intermittent Claudication.
Effect of Creatine Supplementation Associated to Clinical Treatment of the Functional Capacity of Patients With Intermittent Claudication.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    creatine ...

  • Study Participants

    90
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 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.
Study Started
Jun 26
2017
Primary Completion
Feb 28
2019
Anticipated
Study Completion
Jun 30
2019
Anticipated
Last Update
Feb 21
2019

Dietary Supplement Creatine

The experimental group will ingest for seven days (Loading - phase 1), 5g (4x/day) of creatine monohydrate associated with the clinical treatment (30-45 minutes of walking, 3 times a week). Subsequently, they will ingest for 49 days (Maintenance - phase 2), 3g (1x / day) creatine monohydrate associated with clinical treatment (30-45 minutes of walking, 3 times a week). They will be given guidance by telephone, so that they can reach the necessary recommendations for the study.

  • Other names: Creatine and clinical treatment

Dietary Supplement Placebo

The placebo group will ingest for seven days (Loading - phase 1), 5g (4x / day) of dextrose associated to clinical treatment (30-45 minutes of walking, 3 times per week). Subsequently, they will ingest for 49 days (Maintenance phase 2), 3g (1x / day) of dextrose associated with the clinical treatment (30-45 minutes of walking, 3 times a week). They will be given guidance by telephone, so that they can reach the necessary recommendations for the study.

  • Other names: Placebo and clinical treatment

Creatine Experimental

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 Comparator

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)

Criteria 

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
No Results Posted