StrokeNCT03960918
Validation of Oxygen Uptake Efficiency Slope in Patients With Stroke
A study testing aerobic exercise therapy in people with Stroke and Physical Fitness, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Background: Stroke is a cerebrovascular disease which leads to ischemic damage of brain tissue and subsequent neurologic impairment. Aerobic capacity has become an effective prognosis for overall and cardiovascular mortality, but current protocols using in cardiopulmonary test (CPET) are not feasible for the… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke, Physical Fitness, Exercise Therapy
- What is being tested?
- aerobic exercise therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2018to 31 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Cerebrovascular accident, confirmed by a neurologist
Who cannot join
- There are other diseases or behavioral restrictions that prevent exercise training, list below:
- dementia(MMSE<24), and etc.
- musculoskeletal disease
- Other exercise contraindications:
- unstable angina
- resting systolic blood pressure greater than 200 mmHg or diastolic blood pressure greater than 110 mmHg
Show all 16Show fewer
- orthostatic blood pressure drop greater than 20 mmHg with symptoms
- Symptomatic severe aortic stenosis
- Acute systemic infection, accompanied by fever, body aches, or swollen lymph glands
- Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise
- Uncontrolled symptomatic heart failure
- High-degree atrioventricular blocks
- Acute myocarditis or pericarditis
- Acute pulmonary embolus or pulmonary infarction
- a recent significant change in the resting electrocardiogram suggesting significant ischemia,
- recent myocardial infarction (within 2 d), or other acute cardiac events
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital
Keelung, 204
About this study
Background: Stroke is a cerebrovascular disease which leads to ischemic damage of brain tissue and subsequent neurologic impairment. Aerobic capacity has become an effective prognosis for overall and cardiovascular mortality, but current protocols using in cardiopulmonary test (CPET) are not feasible for the hemiplegics due to balance or coordination deficit. The peak oxygen uptake should be underestimated for survival prediction. The calculation of the oxygen uptake efficiency slope (OUES) is independent of incremental exercise protocol, and patient effort, and is, therefore, suitable for patients who are not able or willing to attain maximal exercise values, just like stroke population.
Study Purpose: This project will enroll stroke patients to evaluate their aerobic capacity by CPET. Compared retrospectively with previous data from heart failure patients and healthy subjects, the investigators may know the aerobic capacity of stroke patients is underestimated or not. By collecting other parameters from exercise test (cardiac output and local tissue perfusion and oxygenation), the investigators could investigate the exercise intolerance of stroke patients is contributed from neurological origin mainly or several factors synergically.
Read the detailed description
Background: Stroke is a cerebrovascular disease which leads to ischemic damage of brain tissue and subsequent neurologic impairment. Hence, the brain circulation is impaired after stroke which also play a possible cause for exercise intolerance not only neurogenic origin. The peak oxygen uptake in stroke patients was about half in healthy adults with the same age about 30 days after the disease occurrence. Aerobic capacity has become an effective prognosis for overall and cardiovascular mortality, but current protocols using in cardiopulmonary test (CPET) are not feasible for the hemiplegics due to balance or coordination deficit. The peak oxygen uptake should be underestimated for survival prediction. The calculation of the oxygen uptake efficiency slope (OUES) is independent of incremental exercise protocol, and patient effort, and is, therefore, suitable for patients who are not able or willing to attain maximal exercise values, just like stroke population. So it can be regarded as a single index of aerobic capacity that can be determined from submaximal exercise data. In healthy subjects, the OUES has a test-retest reliability similar to VO2peak (intra-class correlation coefficient (ICC) = 0.890 vs ICC = 0.910). The above properties make the OUES a possible alternative for VO2peak in patients with stroke who are unable to attain maximal exercise, and may provide clinicians with a better estimate of aerobic capacity in these patients.
Study purpose: This project will enroll stroke patients under new onset stage, late stage, and exercise intervention, to evaluate their aerobic capacity by CPET. Compared retrospectively with previous data from heart failure patients and healthy subjects, the investigators may know the aerobic capacity of stroke patients is underestimated or not. By collecting other parameters from exercise test (cardiac output and local tissue perfusion and oxygen), the investigators could investigate the exercise intolerance of stroke patients is contributed from neurological origin mainly or several factors synergically.
Methods: This is prospective (for stroke), randomized, parallel-group (for exercise) design with a 1:1 allocation ratio. 120 stroke patients will be randomly assigned to traditional rehabilitation training group(control) and traditional rehabilitation combined with aerobic training group (experiment). All enrolled subjects will perform a CPET before the training initiation. After CPET, the patients in the experimental group need to perform an additional bicycle training program with the intensity of 60 % maximal workload in the previous CPET (three days per week, for 12 weeks with a total of 36 times). When the training course completed, another CPET will be performed to evaluate the aerobic capacity again. In two CPET, a comprehensive cognitive and functional assessment will be also performed.
Measurable parameters: maximal oxygen uptake, maximal cardiac output, cerebral blood flow, oxygen uptake efficiency slope, limb muscle strength and function, and cognitive function was assessed.
- Conditions
- Stroke, Physical Fitness, Exercise Therapy
- Being tested
- aerobic exercise therapy
- Keywords
- stroke, physical fitness, oxygen uptake efficiency slope (OUES)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise therapyBehavioural
aerobic exercise therapy: All enrolled subjects will perform a CPET before the training initiation. After CPET, the patients in the experimental group need to perform an additional bicycle training program with the intensity of 60 % maximal workload in the previous CPET (five days per week, for four weeks with a total of 20 times).
| Study group | Role | What they receive |
|---|---|---|
| usual neuro-rehab training | No intervention | stroke patient under usual neuro-rehab training |
| Novel exercise training | Experimental | stroke patient under aerobic exercise training Receives: Behavioral: aerobic exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical fitness (peak oxygen consumption)
oxygen consumption in cc/min/kg measured by Carefusion(TM) in CPET
Measured: after 36 session exercise training, up to 12 weeks
physical fitness (maximal cardiac output)
maximal cardiac output in L/min measured by NICOM(TM) in CPET
Measured: after 36 session exercise training, up to 12 weeks
physical fitness(oxygen uptake efficiency slope)
oxygen uptake efficiency slope was calculated with oxygen consumption and workload in CPET
Measured: after 36 session exercise training, up to 12 weeks
physical fitness (cerebral blood flow)
cerebral blood flow in cc/min measured by Near-Infrared spectrometry
Measured: after 36 session exercise training, up to 12 weeks
physical fitness(limb muscle strength)
limb muscle strength was measured by manual muscle test with (0-5) scales
Measured: after 36 session exercise training, up to 12 weeks
Secondary outcomes (2)
neuro-function(cognitive function)
cognitive function was measured by MMSE ( Mini-Mental State Examination)
Measured: after 36 session exercise training, up to 12 weeks
neuro-function(limbs function)
limbs function was measured by brunnstrom stage of stroke recovery with (1-6) scales
Measured: after 36 session exercise training, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start1 Jan 2018
- Primary completion30 Dec 2020 (estimated)
- Study completion31 Dec 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.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- This is prospective (for stroke), randomized, parallel-group (for exercise) design with a 1:1 allocation ratio.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960918
- Sponsor's protocol ID
- 201600569B0
- Status last verified
- May 2019
- First submitted
- 17 May 2019
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Oxygen Uptake Efficiency Slope in Patients With Stroke
- ClinicalTrials.gov ID
- NCT03960918
- Acronym / sponsor ID
- 201600569B0
- Conditions
- Stroke, Physical Fitness, Exercise Therapy
- Keywords
- stroke, physical fitness, oxygen uptake efficiency slope (OUES)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 23 May 2019 (actual)
- 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.
Background: Stroke is a cerebrovascular disease which leads to ischemic damage of brain tissue and subsequent neurologic impairment. Aerobic capacity has become an effective prognosis for overall and cardiovascular mortality, but current protocols using in cardiopulmonary test (CPET) are not feasible for the hemiplegics due to balance or coordination deficit. The peak oxygen uptake should be underestimated for survival prediction. The calculation of the oxygen uptake efficiency slope (OUES) is independent of incremental exercise protocol, and patient effort, and is, therefore, suitable for patients who are not able or willing to attain maximal exercise values, just like stroke population.
Study Purpose: This project will enroll stroke patients to evaluate their aerobic capacity by CPET. Compared retrospectively with previous data from heart failure patients and healthy subjects, the investigators may know the aerobic capacity of stroke patients is underestimated or not. By collecting other parameters from exercise test (cardiac output and local tissue perfusion and oxygenation), the investigators could investigate the exercise intolerance of stroke patients is contributed from neurological origin mainly or several factors synergically.
Detailed description
Background: Stroke is a cerebrovascular disease which leads to ischemic damage of brain tissue and subsequent neurologic impairment. Hence, the brain circulation is impaired after stroke which also play a possible cause for exercise intolerance not only neurogenic origin. The peak oxygen uptake in stroke patients was about half in healthy adults with the same age about 30 days after the disease occurrence. Aerobic capacity has become an effective prognosis for overall and cardiovascular mortality, but current protocols using in cardiopulmonary test (CPET) are not feasible for the hemiplegics due to balance or coordination deficit. The peak oxygen uptake should be underestimated for survival prediction. The calculation of the oxygen uptake efficiency slope (OUES) is independent of incremental exercise protocol, and patient effort, and is, therefore, suitable for patients who are not able or willing to attain maximal exercise values, just like stroke population. So it can be regarded as a single index of aerobic capacity that can be determined from submaximal exercise data. In healthy subjects, the OUES has a test-retest reliability similar to VO2peak (intra-class correlation coefficient (ICC) = 0.890 vs ICC = 0.910). The above properties make the OUES a possible alternative for VO2peak in patients with stroke who are unable to attain maximal exercise, and may provide clinicians with a better estimate of aerobic capacity in these patients.
Study purpose: This project will enroll stroke patients under new onset stage, late stage, and exercise intervention, to evaluate their aerobic capacity by CPET. Compared retrospectively with previous data from heart failure patients and healthy subjects, the investigators may know the aerobic capacity of stroke patients is underestimated or not. By collecting other parameters from exercise test (cardiac output and local tissue perfusion and oxygen), the investigators could investigate the exercise intolerance of stroke patients is contributed from neurological origin mainly or several factors synergically.
Methods: This is prospective (for stroke), randomized, parallel-group (for exercise) design with a 1:1 allocation ratio. 120 stroke patients will be randomly assigned to traditional rehabilitation training group(control) and traditional rehabilitation combined with aerobic training group (experiment). All enrolled subjects will perform a CPET before the training initiation. After CPET, the patients in the experimental group need to perform an additional bicycle training program with the intensity of 60 % maximal workload in the previous CPET (three days per week, for 12 weeks with a total of 36 times). When the training course completed, another CPET will be performed to evaluate the aerobic capacity again. In two CPET, a comprehensive cognitive and functional assessment will be also performed.
Measurable parameters: maximal oxygen uptake, maximal cardiac output, cerebral blood flow, oxygen uptake efficiency slope, limb muscle strength and function, and cognitive function was assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is prospective (for stroke), randomized, parallel-group (for exercise) design with a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| usual neuro-rehab training | No intervention | –stroke patient under usual neuro-rehab training |
| Novel exercise training | Experimental | Behavioral: aerobic exercise therapystroke patient under aerobic exercise training |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Cerebrovascular accident, confirmed by a neurologist
Key exclusion criteria (16 listed)
- There are other diseases or behavioral restrictions that prevent exercise training, list below:
- dementia(MMSE<24), and etc.
- musculoskeletal disease
- Other exercise contraindications:
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 |
|---|---|---|
| aerobic exercise therapyaerobic exercise therapy: All enrolled subjects will perform a CPET before the training initiation. After CPET, the patients in the experimental group need to perform an additional bicycle training program with the intensity of 60 % maximal workload in the previous CPET (five days per week, for four weeks with a total of 20 times). | Behavioural | Novel exercise training |
Primary outcome
physical fitness (peak oxygen consumption)
Time frame: after 36 session exercise training, up to 12 weeks
oxygen consumption in cc/min/kg measured by Carefusion(TM) in CPET
physical fitness (maximal cardiac output)
Time frame: after 36 session exercise training, up to 12 weeks
maximal cardiac output in L/min measured by NICOM(TM) in CPET
physical fitness(oxygen uptake efficiency slope)
Time frame: after 36 session exercise training, up to 12 weeks
oxygen uptake efficiency slope was calculated with oxygen consumption and workload in CPET
physical fitness (cerebral blood flow)
Time frame: after 36 session exercise training, up to 12 weeks
cerebral blood flow in cc/min measured by Near-Infrared spectrometry
physical fitness(limb muscle strength)
Time frame: after 36 session exercise training, up to 12 weeks
limb muscle strength was measured by manual muscle test with (0-5) scales
2 secondary outcomes
neuro-function(cognitive function)
Time frame: after 36 session exercise training, up to 12 weeks
neuro-function(limbs function)
Time frame: after 36 session exercise training, up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise therapy in people with Stroke and Physical Fitness, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 16 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 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical fitness (peak oxygen consumption) (time frame: after 36 session exercise training, up to 12 weeks). The study lists 5 primary outcomes in all. 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 6 Jan 2020.