Creatine Supplementation in Patients With Intermittent Claudication.

NCT02993874 | Unknown DMC

• 1 other identifier: Creatine PAD
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Claudication

Keywords

Ergonemic resources; Walking capacity; Peripheral artery disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change oxygen saturation

  Baseline, one and eight weeks

• Change Short Physical Performance Battery

  Baseline, one and eight weeks

• Change cognitive function

  Baseline, one and eight weeks

Other Outcomes (8)

• Change brachial blood pressure.

  Baseline, one and eight weeks

• Change arterial stiffness

  Baseline, one and eight weeks

• Change autonomic cardiac modulation

  Baseline, one and eight weeks

Study Arms (2)

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)

Dietary Supplement: Creatine

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)

Dietary Supplement: Placebo

Interventions

Creatine DIETARY_SUPPLEMENT

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.

Also known as: Creatine and clinical treatment

Creatine

Placebo DIETARY_SUPPLEMENT

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.

Also known as: Placebo and clinical treatment

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of Maringá: lead
• Fundação de Amparo à Pesquisa do Estado do Amazonas: collaborator

Study Sites (1)

Israel Institute of Education and Research Albert Einstein

São Paulo, 05652900, Brazil

RECRUITING

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Arterial Disease

Interventions

Creatine

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Ademar Avelar, PhD

  State University of Maringa

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Central Study Contacts

Ademar Avelar, PhD

CONTACT

5544984376050; ademaravelar@yahoo.com.br

Wagner Domingues, MD

CONTACT

5511982841355; wagnerfef@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 15, 2016
• Study Start: June 26, 2017
• Primary Completion: February 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 21, 2019

Record last verified: 2019-02

Locations

BR (1)