The Effect of Leg Cycling Exercise Program at Low or Moderate Intensity for Individuals With Subacute Stroke
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
the low-intensity exercise group
the moderate-intensity exercise group
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, exercise capacity
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
control
the low-intensity exercise group
the moderate-intensity exercise group
Arm Description
traditional rehabilitation merely, no ergocycling training
traditional rehabilitation plus the low-intensity ergocycling exercise training
traditional rehabilitation plus the moderate-intensity ergocycling exercise training
Outcomes
Primary Outcome Measures
changed value of symptom-limit exercise tolerance tests
One doctor and one therapist monitor the test. EKG and self-report are used.
Secondary Outcome Measures
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).
10-meter walking test
Time of performing the 10 meters is measured.
changed score of the Barthel index
Using Barthel index questionnaire
changed score of the Stroke-Specific Quality of Life Scale (SSQOL)
Using SSQOL questionnaire
changed value of the Fugl-Meyer Assessment Lower Extremity (FMA-LE)
Measure items of FMA-LE
changed score of Multi-dimensional Fatigue Inventory
Using Multi-dimensional Fatigue Inventory questionnaire
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.
Full Information
NCT ID
NCT02855424
First Posted
July 6, 2016
Last Updated
August 4, 2016
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02855424
Brief Title
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
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, exercise capacity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
traditional rehabilitation merely, no ergocycling training
Arm Title
the low-intensity exercise group
Arm Type
Experimental
Arm Description
traditional rehabilitation plus the low-intensity ergocycling exercise training
Arm Title
the moderate-intensity exercise group
Arm Type
Experimental
Arm Description
traditional rehabilitation plus the moderate-intensity ergocycling exercise training
Intervention Type
Other
Intervention Name(s)
the low-intensity exercise group
Intervention Description
Totally 20-time training, frequency 2-6 time/week, total 20 times.
Intervention Type
Other
Intervention Name(s)
the moderate-intensity exercise group
Intervention Description
Totally 20-time training, frequency 2-6 time/week,total 20 times.
Primary Outcome Measure Information:
Title
changed value of symptom-limit exercise tolerance tests
Description
One doctor and one therapist monitor the test. EKG and self-report are used.
Time Frame
Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
Secondary Outcome Measure Information:
Title
changed activity of autonomic nervous system (ANS)
Description
The frequency domain analysis (measure unit of activity of ANS) is used in two conditions (sit and calculate math; 5 minutes/each condition).
Time Frame
Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
Title
10-meter walking test
Description
Time of performing the 10 meters is measured.
Time Frame
Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
Title
changed score of the Barthel index
Description
Using Barthel index questionnaire
Time Frame
Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
Title
changed score of the Stroke-Specific Quality of Life Scale (SSQOL)
Description
Using SSQOL questionnaire
Time Frame
Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
Title
changed value of the Fugl-Meyer Assessment Lower Extremity (FMA-LE)
Description
Measure items of FMA-LE
Time Frame
Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
Title
changed score of Multi-dimensional Fatigue Inventory
Description
Using Multi-dimensional Fatigue Inventory questionnaire
Time Frame
Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
Title
performance of cycling
Description
the maximal power is recorded by a chip of the training bike continually during each training;2-6 times/week, total 20 times training.
Time Frame
4 weeks to 10 weeks for exercise completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miao-Ju Hsu, PHD
Phone
886-7-3121101
Ext
2673
Email
mjhsu@kmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miao-Ju Hsu, PHD
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Leg Cycling Exercise Program at Low or Moderate Intensity for Individuals With Subacute Stroke
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