Stroke
Conditions
Interventions
The present study is a randomized, single-blind clinical trial. To meet the methodological criteria, 98 volunteers will be included, with 49 participants per group. The interventions will take place a
Sponsors
Universidade Federal de São Carlos
Irmandade Santa Casa de Misericórdia de São Carlos
Eligibility
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: Written informed consent was assigned; able to walk even with supervision or assistive walking devices; both women and men; age: 40 - 80 years old; diagnosis of unilateral stroke (= 6 months = 5 years); medical allowance to perform moderate to vigorous exercise; memory and cognition preserved (considering the Mini-Mental State Examination scored by age and scholar level); be physically inactive (< 7.500 steps per day); at least 2 doses of COVID-19 vaccines Do not attend to another rehabilitation program; no health issues that can cause symptoms and risks for the patients during the evaluations/training protocol (< 1-month acute myocardial infarct/cardiac; surgery or pulmonary obstructive/restrictive diseases); no other neurological diseases than stroke; no orthopedic disease that impossibility to walk
Exclusion criteria
Exclusion criteria: Withdraw the consent; present any severe symptoms during the assessments or intervention, such as prior cardiac surgery and/or acute myocardial infarction within one month; pacemaker utilization, obstructive or restrictive pulmonary diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We expect to increase the daily steps (measured by ActiviPAL4TM micro). Assessments are made 15 days before the treatment, one week after the treatment, and six weeks after reassessment. ;We expect to improve the endothelium function (measured by Flow Mediated Dilatation brachial artery). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment. ;We expect to improve cardiac function (left ventricular ejection). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| We expect to reduce the duration of Physical Inactivity (ActiviPAL4TM micro). Assessments are made 15 days before the treatment, one week after the treatment, and six weeks after reassessment. ;We expect to reduce the sedentary behavior (ActiviPAL4TM micro). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment. ;We expect to increase physical activity level (ActiviPAL4TM micro). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment. ;We expect to improve the marching cadence (ActiviPAL4TM micro). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment. ;We expect to improve the quality of Life (Stroke Specific Quality of Life Questionnaire). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment. ;We expect to reduce sensorimotor impairment (Fugl-Meyer). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment. ;We expect to improve the functional balance (Dynamic Gait Index and Timed Up and Go). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment. ;We expect to increase walking speed (Ten Meter Walk Test). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment. ;We expect to increase the lower limb strength (Five Times Sit-to-Stand Test). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment. ;We expect to improve the self-perceived assistance level, performance quality, and confidence (Lower Extremity Motor Activity Log). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment. ;We expect to increase the walk endurance (6-minute walk tes | — |
Countries
Brazil
Contacts
Public ContactThiago de Russo
Universidade Federal de São Carlos
Outcome results
None listed