Early Intervention With a Low-intensity Leg Cycling Exercise Program for Individuals After Stroke

Study Overview
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Brief Summary
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This is a two-stage study. In the first stage, 30 subjects with stroke (onset > 2 weeks) are recruited, and they are assessed and recorded with clinical characteristics, sympathetic nerve testing, and twice symptom-limit exercise capacity tests. The second stage would recruited 90 subjects with stroke (onset>2 weeks), and they are randomized to one of three groups (control, low-intensity, high-intensity). They are evaluated before and after the four-week interval with clinical characteristics and twice symptom-limit exercise capacity tests (baseline and after four-week training) .

Detailed Description
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This is a two-stage study. In the first stage, 30 subjects with stroke (onset > 2 weeks) are recruited, and they are assessed and recorded with sympathetic nerve testing, anthropometry, and twice symptom-limit exercise capacity tests.The second stage would recruited 90 subjects with stroke (onset>2 weeks), and they are randomized to one of three groups. The control group undergoes traditional rehabilitation only, The low-intensity exercise group receives a low-intensity four-week cycle ergometry and traditional rehabilitation. The The high-intensity exercise group gets a high-intensity four-week cycle ergometry and traditional rehabilitation. They are evaluated by sympathetic tests, anthropometry, functional scales and activity questionnaires, and symptom-limit exercise capacity tests before and after the four-week training.

Official Title
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Early Intervention With a Low-intensity Leg Cycling Exercise Program for Individuals After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Other: exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stroke onset longer than two weeks, eligible for exercise testing by Doctor Exclusion Criteria: aphasia, apraxia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: rehabilitation<br>half an hour physical and half an hour occupational therapy in rehabilitation | |
| Experimental: Low-intensity exercise<br>Low-intensity exercise plus rehabilitation | Other: exercise<br>* cycle ergometry<br>|
| Experimental: High-intensity exercise<br>High-intensity exercise plus rehabilitation | Other: exercise<br>* cycle ergometry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change values of symptom-limit exercise capacity | value was showed by oxygen uptake (mL/kg/min) | baseline and after four-week training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change values of sympathetic nerve tests | change value was measure by blood pressure (from lying to stand, mm-Hg) at baseline and after four weeks | baseline and after four-week training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, exercise capacity