Intermittent Claudication
Conditions
Keywords
Ergonemic resources, Walking capacity, Peripheral artery disease
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.
Interventions
DIETARY_SUPPLEMENTCreatine
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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Fundação de Amparo à Pesquisa do Estado do Amazonas
State University of Maringá
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change walking capacity | 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
| Measure | Time frame | Description |
|---|---|---|
| Change oxygen saturation | 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). |
| Change Short Physical Performance Battery | 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). |
| Change cognitive function | 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
| Measure | Time frame | Description |
|---|---|---|
| Change body composition | 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). |
| Creatine plasma | 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). |
| Change brachial blood pressure. | 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). |
| Food habits | 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 |
| Change of Renal function markers | Baseline, one and eight weeks | 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. |
| Change arterial stiffness | 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). |
| Change autonomic cardiac modulation | 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). |
| Change vasodilatory capacity | 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). |
Countries
Brazil
Contacts
Primary ContactAdemar Avelar, PhD
Backup ContactWagner Domingues, MD
Outcome results
None listed