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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02855424
Enrollment
90
Registered
2016-08-04
Start date
2016-08-31
Completion date
2020-12-31
Last updated
2016-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, exercise capacity

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.

Interventions

OTHERthe low-intensity exercise group

Totally 20-time training, frequency 2-6 time/week, total 20 times.

OTHERthe moderate-intensity exercise group

Totally 20-time training, frequency 2-6 time/week,total 20 times.

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
changed value of symptom-limit exercise tolerance testsBaseline, 4 weeks to 10 weeks for exercise completion, one-month follow-upOne doctor and one therapist monitor the test. EKG and self-report are used.

Secondary

MeasureTime frameDescription
10-meter walking testBaseline, 4 weeks to 10 weeks for exercise completion, one-month follow-upTime of performing the 10 meters is measured.
changed score of the Barthel indexBaseline, 4 weeks to 10 weeks for exercise completion, one-month follow-upUsing Barthel index questionnaire
changed score of the Stroke-Specific Quality of Life Scale (SSQOL)Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-upUsing SSQOL questionnaire
changed activity of autonomic nervous system (ANS)Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-upThe frequency domain analysis (measure unit of activity of ANS) is used in two conditions (sit and calculate math; 5 minutes/each condition).
changed score of Multi-dimensional Fatigue InventoryBaseline, 4 weeks to 10 weeks for exercise completion, one-month follow-upUsing Multi-dimensional Fatigue Inventory questionnaire
performance of cycling4 weeks to 10 weeks for exercise completionthe maximal power is recorded by a chip of the training bike continually during each training;2-6 times/week, total 20 times training.
changed value of the Fugl-Meyer Assessment Lower Extremity (FMA-LE)Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-upMeasure items of FMA-LE

Contacts

Primary ContactMiao-Ju Hsu, PHD
mjhsu@kmu.edu.tw886-7-3121101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026