Creatine Supplementation in Patients With Intermittent Claudication.
Primary Purpose
Intermittent Claudication
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Creatine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Intermittent Claudication focused on measuring Ergonemic resources, Walking capacity, Peripheral artery disease
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
Sites / Locations
- Israel Institute of Education and Research Albert EinsteinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Creatine
Placebo
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
Full Information
NCT ID
NCT02993874
First Posted
December 12, 2016
Last Updated
February 19, 2019
Sponsor
State University of Maringá
Collaborators
Fundação de Amparo à Pesquisa do Estado do Amazonas
1. Study Identification
Unique Protocol Identification Number
NCT02993874
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 26, 2017 (Actual)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of Maringá
Collaborators
Fundação de Amparo à Pesquisa do Estado do Amazonas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication
Keywords
Ergonemic resources, Walking capacity, Peripheral artery disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Creatine
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Creatine
Other Intervention Name(s)
Creatine and clinical treatment
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo and clinical treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change walking capacity
Description
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).
Time Frame
Baseline, one and eight weeks
Secondary Outcome Measure Information:
Title
Change oxygen saturation
Description
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).
Time Frame
Baseline, one and eight weeks
Title
Change Short Physical Performance Battery
Description
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).
Time Frame
Baseline, one and eight weeks
Title
Change cognitive function
Description
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).
Time Frame
Baseline, one and eight weeks
Other Pre-specified Outcome Measures:
Title
Change brachial blood pressure.
Description
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).
Time Frame
Baseline, one and eight weeks
Title
Change arterial stiffness
Description
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).
Time Frame
Baseline, one and eight weeks
Title
Change autonomic cardiac modulation
Description
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).
Time Frame
Baseline, one and eight weeks
Title
Change vasodilatory capacity
Description
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).
Time Frame
Baseline and eight weeks
Title
Change body composition
Description
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).
Time Frame
Baseline and eight weeks
Title
Creatine plasma
Description
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).
Time Frame
Baseline, one and eight weeks
Title
Change of Renal function markers
Description
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.
Time Frame
Baseline, one and eight weeks
Title
Food habits
Description
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
Time Frame
Baseline, one and eight weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ademar Avelar, PhD
Phone
5544984376050
Email
ademaravelar@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Wagner Domingues, MD
Phone
5511982841355
Email
wagnerfef@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ademar Avelar, PhD
Organizational Affiliation
State University of Maringa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raphael Ritti-Dias, PhD
Organizational Affiliation
Israel Institute of Education and Research Albert Einstein
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gabriel Cucato, PhD
Organizational Affiliation
Israel Institute of Education and Research Albert Einstein
Official's Role
Study Director
Facility Information:
Facility Name
Israel Institute of Education and Research Albert Einstein
City
Sao Paulo
ZIP/Postal Code
05652900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wagner Domingues, MD
Phone
5511982841355
Email
wagnerfef@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Creatine Supplementation in Patients With Intermittent Claudication.
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