The Effect of Leg Cycling Exercise Program at Low or Moderate Intensity for Individuals With Subacute Stroke

Study Overview
=================
Brief Summary
-----------------
Poor cardiopulmonary endurance is observed in individuals with acute stroke, even in chronic. In addition, the poor fitness may obstacle activities of daily life, decrease activities of autonomic system, and increase risks of recurrent, therefore, the cardiopulmonary endurance training should be included into the early-stage rehabilitation program. The ergocycling training could improve cardiopulmonary endurance for individuals with stroke. Moreover, the low-intensity exercise training can increase the willingness, and it is safer than the moderate-intensity exercise training. However, it needs to be evaluated whether the low-intensity exercise training can bring sufficient benefits, compared to the moderate-intensity exercise training. Objectives of the study is to compare the exercise benefits between the low-intensity and moderate-intensity exercise training, and then these would offer optimal exercise prescription and considerations in clinical practice.

Detailed Description
-----------------
After giving their signed consent, subjects would be randomly assigned into the control group (traditional rehabilitation), the low-intensity exercise group (traditional rehabilitation plus low-intensity exercise training), or the moderate-intensity exercise group (traditional rehabilitation plus the moderate-intensity exercise training). Frequency of the exercise training is 2-6 times/week, totally 20 times. In the symptom-limit exercise tolerance tests, subjects wear a gas-collecting mask and electrocardiogram, and pre-set graduated loading was offered by the bike. One therapists and one doctor would monitor the test. For resistance and time setting within each exercise training, it is customized by results of exercise tolerance tests in baseline and the allocation. Moreover, a therapist would stay with subject ,monitor the training, and measure the blood pressure before and after the training.

Official Title
-----------------
The Effect of Leg Cycling Exercise Program at Low or Moderate Intensity for Individuals With Subacute Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: the low-intensity exercise group
* Other: the moderate-intensity exercise group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the first-ever stroke period of ischemic stroke onset is longer than two weeks, and less than six months, and the doctors agree with exercise training unilateral hemiplegia no obvious deficits of cognition. Scores of three items in the National Institutes of Health Stroke Scale are zero be willing to join this study and give their consent Exclusion Criteria: aphasia orthopedic problems (severe arthritis), neurologic injury (eg. peripheral nerve injury) that can interfere with movement of the lower limb, or cannot sit independently with pace maker, severe cardiac arrhythmia, or heart failure abnormal electrocardiography in rest, is not suitable for exercise tolerance test according to the American College of Sports Medicine guidance, for example, the atrioventricular block (AV block).

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>traditional rehabilitation merely, no ergocycling training | |
| Experimental: the low-intensity exercise group<br>traditional rehabilitation plus the low-intensity ergocycling exercise training | Other: the low-intensity exercise group<br>* Totally 20-time training, frequency 2-6 time/week, total 20 times.<br>|
| Experimental: the moderate-intensity exercise group<br>traditional rehabilitation plus the moderate-intensity ergocycling exercise training | Other: the moderate-intensity exercise group<br>* Totally 20-time training, frequency 2-6 time/week,total 20 times.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changed value of symptom-limit exercise tolerance tests | One doctor and one therapist monitor the test. EKG and self-report are used. | Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changed activity of autonomic nervous system (ANS) | The frequency domain analysis (measure unit of activity of ANS) is used in two conditions (sit and calculate math; 5 minutes/each condition). | Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up | 
| 10-meter walking test | Time of performing the 10 meters is measured. | Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up | 
| changed score of the Barthel index | Using Barthel index questionnaire | Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up | 
| changed score of the Stroke-Specific Quality of Life Scale (SSQOL) | Using SSQOL questionnaire | Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up | 
| changed value of the Fugl-Meyer Assessment Lower Extremity (FMA-LE) | Measure items of FMA-LE | Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up | 
| changed score of Multi-dimensional Fatigue Inventory | Using Multi-dimensional Fatigue Inventory questionnaire | Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up | 
| performance of cycling | the maximal power is recorded by a chip of the training bike continually during each training;2-6 times/week, total 20 times training. | 4 weeks to 10 weeks for exercise completion | 

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