Creatine Supplementation in Patients With Intermittent Claudication.

Effect of Creatine Supplementation Associated to Clinical Treatment of the Functional Capacity of 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.

Study Overview

• Status: Unknown
• Conditions: Intermittent Claudication
• Intervention / Treatment: Dietary supplement: Creatine; Dietary supplement: Placebo

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
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ademar Avelar, PhD; Phone Number: 5544984376050; Email: ademaravelar@yahoo.com.br
• Study Contact Backup: Name: Wagner Domingues, MD; Phone Number: 5511982841355; Email: wagnerfef@gmail.com

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05652900
    • Recruiting
    • Israel Institute of Education and Research Albert Einstein
    • Contact: Wagner Domingues, MD; Phone Number: 5511982841355; Email: wagnerfef@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Placebo and clinical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change walking capacity	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).	Baseline, one and eight weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change oxygen saturation	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).	Baseline, one and eight weeks
Change Short Physical Performance Battery	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).	Baseline, one and eight weeks
Change cognitive function	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).	Baseline, one and eight weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change brachial blood pressure.	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).	Baseline, one and eight weeks
Change arterial stiffness	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).	Baseline, one and eight weeks
Change autonomic cardiac modulation	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).	Baseline, one and eight weeks
Change vasodilatory capacity	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).	Baseline and eight weeks
Change body composition	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).	Baseline and eight weeks
Creatine plasma	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).	Baseline, one and eight weeks
Change of Renal function markers	serum creatinine,creatinine excretion rate and creatinine clearance. 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.	Baseline, one and eight weeks
Food habits	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	Baseline, one and eight weeks

Collaborators and Investigators

• Sponsor: State University of Maringá
• Collaborators: Fundação de Amparo à Pesquisa do Estado do Amazonas
• Investigators: Principal Investigator: Ademar Avelar, PhD, State University of Maringá; Study Director: Gabriel Cucato, PhD, Israel Institute of Education and Research Albert Einstein; Study Director: Raphael Ritti-Dias, PhD, Israel Institute of Education and Research Albert Einstein

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2017
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimate): December 15, 2016

Study Record Updates

• Last Update Posted (Actual): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Walking capacity; Peripheral artery disease; Ergonemic resources
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Intermittent Claudication
• Other Study ID Numbers: Creatine PAD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No