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Creatine Supplementation in Patients With Intermittent Claudication.

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ClinicalTrials.gov Identifier: NCT02993874
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : June 1, 2018
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado do Amazonas
Information provided by (Responsible Party):
Ademar Avelar de Almeida Junior, State University of Maringá

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.

Condition or disease Intervention/treatment Phase
Intermittent Claudication Dietary Supplement: Creatine Dietary Supplement: Placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Creatine Supplementation Associated to Clinical Treatment of the Functional Capacity of Patients With Intermittent Claudication.
Actual Study Start Date : June 26, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
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 Name: Creatine and clinical treatment

Placebo Comparator: 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)
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 Name: Placebo and clinical treatment




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Other Outcome Measures:
  1. Change brachial blood pressure. [ Time Frame: Baseline, one and eight weeks ]
    Brachial blood pressure will be assessed through an automatic monitor (HEM-742, Omron Healthcare, Japan) before, after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).

  2. Change arterial stiffness [ Time Frame: Baseline, one and eight weeks ]
    The arterial stiffness will be evaluated by the applanation tonometry method (SphygmoCor, AtCor Medical, Australia) before, after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).

  3. Change autonomic cardiac modulation [ Time Frame: Baseline, one and eight weeks ]
    The autonomic cardiac modulation will be evaluated through a heart rate monitor (Polar, RS 800, USA) after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA).

  4. Change vasodilatory capacity [ Time Frame: Baseline and eight weeks ]
    Vasodilatation capacity will be assessed by ultrasound imaging (HDI 5000 Sono CT, Philips, The Netherlands) after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups ( Cr and PLA).

  5. Change body composition [ Time Frame: Baseline and eight weeks ]
    Body composition will be evaluated after one week (Loading - 7 days) and after 7 weeks of supplementation (Maintenance - 49 days) in both groups (Cr and PLA) using the bio-electrical bioimpedance method (BIS 4200B Xitron Technologies, Inc, San Diego, PLA).

  6. Creatine plasma [ Time Frame: Baseline, one and eight weeks ]
    Creatine plasma will be evaluated by the High Performance Liquid Chromatography (HPLC) method (FL SPD-20A Shimadzu®, Kyoto, Japan), after one week (loading - 7 days) and after 7 weeks of supplementation (maintenance - 49 days) in both The groups (Cr and PLA).

  7. Change of Renal function markers - creatinine clearance [ Time Frame: Baseline, one and eight weeks ]
    Urine will be collected during the 24-hour period, neglecting the first collection. For the measurement of the urinary volume, beakers of 500 to 1000 ml were used. Blood and urinary creatinine levels were determined by the Jaffé method without deproteinization.

  8. Food habits [ Time Frame: Baseline, one and eight weeks ]
    For food intake evaluation a 24-hour food diary will be required by previously trained nutritionists, using the nutritional evaluation program Avanutry 3.1.4



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993874


Contacts
Contact: Ademar Avelar, PhD 5544984376050 ademaravelar@yahoo.com.br
Contact: Wagner Domingues, MD 5511982841355 wagnerfef@gmail.com

Locations
Brazil
Israel Institute of Education and Research Albert Einstein Recruiting
Sao Paulo, Brazil, 05652900
Contact: Wagner Domingues, MD    5511982841355    wagnerfef@gmail.com   
Sponsors and Collaborators
State University of Maringá
Fundação de Amparo à Pesquisa do Estado do Amazonas
Investigators
Principal Investigator: Ademar Avelar, PhD State University of Maringa
Study Director: Raphael Ritti-Dias, PhD Israel Institute of Education and Research Albert Einstein
Study Director: Gabriel Cucato, PhD Israel Institute of Education and Research Albert Einstein

Responsible Party: Ademar Avelar de Almeida Junior, PhD, State University of Maringá
ClinicalTrials.gov Identifier: NCT02993874     History of Changes
Other Study ID Numbers: Creatine PAD
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ademar Avelar de Almeida Junior, State University of Maringá:
Ergonemic resources
Walking capacity
Peripheral artery disease

Additional relevant MeSH terms:
Intermittent Claudication
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms