Peripheral arterial disease with intermittent claudication Circulatory System Other peripheral vascular diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adults of both sexes who have ABI 0.4 or who do not have pain at rest
Exclusion criteria
Exclusion criteria: 1. Individuals with ABI > 0.9 2. Presence of diseases or complications that preclude training, such as cardiac failure, unstable angina, arrhythmias, decompensated diabetes (random glucose greater than 250 mg / dl) or signs of haemodynamic instability 3. Patients who have supervised exercise done during the last six months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 26/10/2015: 1. Initial claudication time (ICT) and absolute claudication time (ACT), initial claudication distance (ICD) and absolute claudication distance (ACD) and resting time required for the symptoms disappear in SWT and constant speed treadmill test 2. Number of plantar flexions performed in the HRT (time in seconds) and velocity (plantar flexions per second) when performing plantar flexions up to the point of volunteer fatigue The results will be measured at time 0 (before intervention) and after 12 weeks of intervention Previous primary outcome measures: Speed and distance walked during the 6WT and SWT The results will be measured at time 0 (before intervention) and after 12 weeks of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 26/10/2015: 1. Walking Impairment Questionnaire (WIQ) score in each domain 2. Deoxyhemoglobin (Hb), oxyhemoglobin (HbO2) and oxygen saturation (StO2) in the calf muscles during SWT, HRT and constant speed treadmill test 3. Short Physical Performance Battery (SPPB) score 4. Heart Rate Variability (HRV) during rest and constant speed treadmill test The results will be measured at time 0 (before intervention) and after 12 weeks of intervention Previous secondary outcome measures: 1 Clinical outcomes (time to onset of pain, distance walked by initial pain, duration of maximum pain on SWT and 6WT tests, resting time required for the symptoms disappear) 2. ABI 3. Quality of life (SF-36) The results will be measured at time 0 (before intervention) and after 12 weeks of intervention | — |
Countries
Brazil