Clinical trial NCT02855424: The Effect of Leg Cycling Exercise Program at Low or Moderate Intensity for Individuals With Subacute Stroke
Official title: The Effect of Leg Cycling Exercise Program at Low or Moderate Intensity for Individuals With Subacute Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke
exercise capacity
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. the first-ever stroke
2. period of ischemic stroke onset is longer than two weeks, and less than six months, and the doctors agree with exercise training
3. unilateral hemiplegia
4. no obvious deficits of cognition. Scores of three items in the National Institutes of Health Stroke Scale are zero
5. be willing to join this study and give their consent

Exclusion Criteria:

1. aphasia
2. orthopedic problems (severe arthritis), neurologic injury (eg. peripheral nerve injury) that can interfere with movement of the lower limb, or cannot sit independently
3. with pace maker, severe cardiac arrhythmia, or heart failure
4. 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).

Primary outcomes:
measure: changed value of symptom-limit exercise tolerance tests
timeFrame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
Secondary outcomes:
measure: changed activity of autonomic nervous system (ANS)
timeFrame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
measure: 10-meter walking test
timeFrame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
measure: changed score of the Barthel index
timeFrame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
measure: changed score of the Stroke-Specific Quality of Life Scale (SSQOL)
timeFrame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
measure: changed value of the Fugl-Meyer Assessment Lower Extremity (FMA-LE)
timeFrame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
measure: changed score of Multi-dimensional Fatigue Inventory
timeFrame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
measure: performance of cycling
timeFrame: 4 weeks to 10 weeks for exercise completion
Other outcomes:
Locations:
Study officials:
affiliation: Kaohsiung Medical University
name: Miao-Ju Hsu, PHD
role: PRINCIPAL_INVESTIGATOR
References: