Peripheral arterial disease
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical trial. In order to investigate the effectiveness of a home-based exercise program in functional capacity, peripheral muscle oxygenation
G11.427.410.698.277
Sponsors
Universidade Federal de Minas Gerais
Hospital das Clínicas da Universidade Federal de Minas Gerais (HC-UFMG)
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Individuals over 18 years of age and with a diagnosis of peripheral arterial disease confirmed by the service; who have an ankle-brachial index at rest below 0.90; complain of intermittent claudication; no pain at rest; clinical stability no decompensation or hospitalization in the last three months; and who have access to a telephone
Exclusion criteria
Exclusion criteria: Will not be eligible subjects whose gait is limited by a condition other than peripheral arterial disease (such as orthopedic; neurological or respiratory problems); who have any medical condition in which exercise is contraindicated (e.g. sepsis; critical limb ischemia; unstable angina; severe heart failure; active malignancy); and/or those who, in the concomitant presence of coronary artery disease are considered to be at high risk for moderate-intensity physical exercise; and/or have cognitive impairment assessed using the Mini-State Examination Mental in individuals aged equal or older to 60 years through the cut-off point of 13 for illiterates, 18 for low and medium schooling and 26 for high schooling; and/or are unable to understand and perform the procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the improvement in functional capacity, assessed by the Incremental Shuttle Walk Test (ISWT) and verified by an increase of at least 70 meters in the total distance covered in the test, through data collected one week before the intervention and one week after the end of the intervention. It is expected to find similar increases in the total distance covered in the test in the home-based exercise program group (HBEP) compared to face-to-face outpatient rehabilitation program (FORP) group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the increase in time taken to reach maximum pain and reduction in rest time needed to resolve symptoms in the Incremental Shuttle Walk Test (ISWT). An increase of at least 95 seconds in time to maximum pain is expected, and results are expected to be similar between groups.;Evaluate the increase in total distance walked, increase in maximum pain time and reduction in rest time required for symptoms to disappear in the submaximal treadmill walk test with constant speed and incline (3.2 km/h and 10% incline). An increase of at least 95 seconds in time to maximum pain is expected and improvement is expected to be similar between groups.;Evaluate the improvement in quality of life, investigated by the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), through the finding of an increase in the total score of the questionnaire, and in the subscales mental health and physical health, of at least five points before and after intervention. It is expected to find similar increases in scores between the groups.;Evaluate the improvement in peripheral muscle oxygenation, measured by Near Infrared Spectroscopy (NIRS), through the analysis of the relative concentrations of oxyhemoglobin and deoxyhemoglobin, and calculation of the oxygen saturation of the gastrocnemius muscle during the effort, evaluated during the performance the Incremental Shuttle Walk Test (ISWT) and the treadmill walk test with constant speed and incline (3.2 km/h and 10% incline). It is expected to find after the intervention an improvement in the patterns of deoxygenation and muscle reoxygenation, with an increase in the time to reach maximum deoxygenation and a reduction in the reoxygenation time, of at least 10%. Similar results are expected between the groups.;Evaluate the improvement in the self-report functional impairment of individuals with peripheral arterial disease, investigated by the Walking Impairment Questionnaire (WIQ), through the observation of an increase in the score i | — |
Countries
Brazil
Contacts
Public ContactIsabella Nascimento
Universidade Federal de Minas Gerais
Outcome results
None listed