StrokeNCT02855424
The Effect of Leg Cycling Exercise Program at Low or Moderate Intensity for Individuals With Subacute Stroke
A study testing the low-intensity exercise group and the moderate-intensity exercise group in people with Stroke, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- the low-intensity exercise group and the moderate-intensity exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- the low-intensity exercise group, the moderate-intensity exercise group
- Keywords
- stroke, exercise capacity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the low-intensity exercise groupOther
Totally 20-time training, frequency 2-6 time/week, total 20 times.
the moderate-intensity exercise groupOther
Totally 20-time training, frequency 2-6 time/week,total 20 times.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | traditional rehabilitation merely, no ergocycling training |
| the low-intensity exercise group | Experimental | traditional rehabilitation plus the low-intensity ergocycling exercise training Receives: Other: the low-intensity exercise group |
| the moderate-intensity exercise group | Experimental | traditional rehabilitation plus the moderate-intensity ergocycling exercise training Receives: Other: the moderate-intensity exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
changed value of symptom-limit exercise tolerance tests
One doctor and one therapist monitor the test. EKG and self-report are used.
Measured: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
Secondary outcomes (7)
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).
Measured: 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.
Measured: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
changed score of the Barthel index
Using Barthel index questionnaire
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 4 weeks to 10 weeks for exercise completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miao-Ju Hsu, PHD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855424
- Sponsor's protocol ID
- KUMHIRB-F(II)-2016002
- Status last verified
- Jun 2016
- First submitted
- 6 Jul 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Leg Cycling Exercise Program at Low or Moderate Intensity for Individuals With Subacute Stroke
- ClinicalTrials.gov ID
- NCT02855424
- Acronym / sponsor ID
- KUMHIRB-F(II)-2016002
- Conditions
- Stroke
- Keywords
- stroke, exercise capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –traditional rehabilitation merely, no ergocycling training |
| the low-intensity exercise group | Experimental | Other: the low-intensity exercise grouptraditional rehabilitation plus the low-intensity ergocycling exercise training |
| the moderate-intensity exercise group | Experimental | Other: the moderate-intensity exercise grouptraditional rehabilitation plus the moderate-intensity ergocycling exercise training |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the low-intensity exercise groupTotally 20-time training, frequency 2-6 time/week, total 20 times. | Other | the low-intensity exercise group |
| the moderate-intensity exercise groupTotally 20-time training, frequency 2-6 time/week,total 20 times. | Other | the moderate-intensity exercise group |
Primary outcome
changed value of symptom-limit exercise tolerance tests
Time frame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
One doctor and one therapist monitor the test. EKG and self-report are used.
7 secondary outcomes
changed activity of autonomic nervous system (ANS)
Time frame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
10-meter walking test
Time frame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
changed score of the Barthel index
Time frame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
changed score of the Stroke-Specific Quality of Life Scale (SSQOL)
Time frame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
changed value of the Fugl-Meyer Assessment Lower Extremity (FMA-LE)
Time frame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
changed score of Multi-dimensional Fatigue Inventory
Time frame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
performance of cycling
Time frame: 4 weeks to 10 weeks for exercise completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miao-Ju Hsu, PHD principal investigator
Kaohsiung Medical University
Questions about this trial
What is this clinical trial studying?
A study testing the low-intensity exercise group and the moderate-intensity exercise group in people with Stroke, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miao-Ju Hsu, PHD (886-7-3121101 ext. 2673, mjhsu@kmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changed value of symptom-limit exercise tolerance tests (time frame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2016.