Peripheral Arterial Disease Other specific peripheral vascular diseases
Conditions
Interventions
This is a randomized, placebo-controlled clinical trial with two parallel arms, random allocation, and double-blinding. Intervention group: 20 participants will receive creatine supplementation, consi
Sponsors
Universidade Estadual Paulista "Júlio de Mesquita Filho"- UNESP
Universidade Estadual Paulista "
Júlio de Mesquita Filho"
- UNESP
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients with age greater than eighteen years; diagnosis of symptomatic peripheral arterial disease (PAD); presence of intermittent claudication in one or both lower limbs; peripheral arterial disease documented by absence or reduction of distal pulses on palpation in the affected limb; ankle-brachial index less than zero point ninety; clinical classification compatible with peripheral arterial disease according to the severity criteria of the Rutherford and/or Fontaine classifications; ability to understand and follow the study instructions; agreement to participate in the study by signing the Informed Consent Form.
Exclusion criteria
Exclusion criteria: Diagnosis of dementia; critical limb ischemia; presence of foot ulcers; amputation; residence in a nursing home; inability to walk on a treadmill or to perform exercise three times per week; failure to complete the initial exercise sessions; history of surgery or myocardial infarction within the last three months; planned surgery within the next year; current participation in other clinical trials; medical contraindication to perform physical exercise; limitation to walk due to a cause not related to peripheral arterial disease (PAD); poorly controlled hypertension; previous kidney disease with creatinine clearance less than or equal to thirty milliliters per minute per one point seventy-three square meters.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distance cTo evaluate the effect of creatine supplementation associated with walking exercise on the functional capacity of patients with peripheral arterial disease and intermittent claudication. An increase in the distance walked during the treadmill walking test, improvement in walking speed, and an increase in the time to onset of claudication are expected. The outcome will be verified by means of a standardized treadmill walking test and by the application of the Walking Impairment Questionnaire. An increase in the total distance walked, an increase in the time to onset of claudication, and improvement in the Walking Impairment Questionnaire scores will be observed when comparing pre- and post-intervention measurements over the 12 weeks of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effects of supplementation associated with walking exercise on muscle mass, muscle function, muscle power, fatigue, pain, and serum biomarkers related to oxidative stress, inflammation, and muscle metabolism. An improvement in muscle mass, muscle function, and muscle power is expected, as well as a reduction in fatigue, pain, and levels of inflammatory and oxidative stress biomarkers. The outcomes will be verified by means of muscle ultrasonography and bioelectrical impedance analysis for the assessment of muscle mass; handgrip strength test using a dynamometer to evaluate upper limb muscle function; the 30-Second Chair Stand test to assess lower limb muscle strength; the sit-to-stand test to evaluate muscle power; application of specific questionnaires and a Likert scale to assess fatigue and pain; and analysis of serum biomarkers (8-OHdG, MDA, GPX, TAC, GDF-15, IGF-1, and PGRN) obtained through blood collection. Changes in muscle mass measurements, functional test results, questionnaire scores, and concentrations of serum biomarkers will be observed by comparing the values obtained at moments M1, M2, and M3 during the follow-up period. | — |
Countries
BR
Contacts
Public ContactThais Piccoli
Universidade Estadual Paulista "Júlio de Mesquita Filho"- UNESP
Outcome results
None listed