Clinical Trial: Creatine Supplementation in Patients With Intermittent Claudication.

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

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

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 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. 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.
Sponsor: State University of Maringá

Current Primary Outcome: Change walking capacity [ Time Frame: 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).


Original Primary Outcome: Change walking capacity [ Time Frame: Baseline, one and eight weeks ]

The walking capacity will be assessed through the six-minute walk test, before, after one week (Loading - 7 days) and after 7 weeks (Maintenance - 49 days) of supplementation in both groups (Cr and PLA).


Current Secondary Outcome:

  • Change oxygen saturation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).


Original Secondary Outcome:

  • Change saturation of oxygen [ Time Frame: Baseline, one and eight weeks ]
    Oxygen saturation will be assessed during the six-minute walk test on calf region through Near-infrared spectroscopy (NIRS, PortaMon, Artinis Medical Systems) before, after one week (Loading - 7 days) and after 7 weeks (Maintenance - 49 days) of supplementation in both groups (Cr and PLA).
  • Change Short Physical Performance Battery [ Time Frame: Baseline, one and eight weeks ]
    Functional capacity will be assessed through the Short Physical Performance Battery test, after one week (Loading - 7 days) and after 7 weeks (Maintenance - 49 days) of supplementation in both groups (Cr and PLA).


Information By: State University of Maringá

Dates:
Date Received: December 12, 2016
Date Started: August 1, 2017
Date Completion: February 2019
Last Updated: April 20, 2017
Last Verified: April 2017