Clinical trial NCT02993874: Creatine Supplementation in Patients With Intermittent Claudication.
Official title: Effect of Creatine Supplementation Associated to Clinical Treatment of the Functional Capacity of Patients With Intermittent Claudication.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intermittent Claudication
Keywords: Ergonemic resources
Walking capacity
Peripheral artery disease
Lead sponsor: State University of Maringá
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Amazonas
First posted: 2016-12-15
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change walking capacity
timeFrame: Baseline, one and eight weeks
Secondary outcomes:
measure: Change oxygen saturation
timeFrame: Baseline, one and eight weeks
measure: Change Short Physical Performance Battery
timeFrame: Baseline, one and eight weeks
measure: Change cognitive function
timeFrame: Baseline, one and eight weeks
Other outcomes:
measure: Change brachial blood pressure.
timeFrame: Baseline, one and eight weeks
measure: Change arterial stiffness
timeFrame: Baseline, one and eight weeks
measure: Change autonomic cardiac modulation
timeFrame: Baseline, one and eight weeks
measure: Change vasodilatory capacity
timeFrame: Baseline and eight weeks
measure: Change body composition
timeFrame: Baseline and eight weeks
measure: Creatine plasma
timeFrame: Baseline, one and eight weeks
measure: Change of Renal function markers
timeFrame: Baseline, one and eight weeks
measure: Food habits
timeFrame: Baseline, one and eight weeks
Locations:
city: Sao Paulo
country: Brazil
facility: Israel Institute of Education and Research Albert Einstein
Study officials:
affiliation: State University of Maringa
name: Ademar Avelar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Israel Institute of Education and Research Albert Einstein
name: Raphael Ritti-Dias, PhD
role: STUDY_DIRECTOR
affiliation: Israel Institute of Education and Research Albert Einstein
name: Gabriel Cucato, PhD
role: STUDY_DIRECTOR
References: