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出境医 / 临床实验 / Validation of Oxygen Uptake Efficiency Slope in Patients With Stroke

Validation of Oxygen Uptake Efficiency Slope in Patients With Stroke

Study Description
Brief 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 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.


Condition or disease Intervention/treatment Phase
Stroke Physical Fitness Exercise Therapy Behavioral: aerobic exercise therapy Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is prospective (for stroke), randomized, parallel-group (for exercise) design with a 1:1 allocation ratio.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Validation of Oxygen Uptake Efficiency Slope in Patients With Stroke
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
Arm Intervention/treatment
No Intervention: usual neuro-rehab training
stroke patient under usual neuro-rehab training
Experimental: Novel exercise training
stroke patient under aerobic exercise training
Behavioral: aerobic exercise therapy
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).

Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. neuro-function(cognitive function) [ Time Frame: after 36 session exercise training, up to 12 weeks ]
    cognitive function was measured by MMSE ( Mini-Mental State Examination)

  2. neuro-function(limbs function) [ Time Frame: after 36 session exercise training, up to 12 weeks ]
    limbs function was measured by brunnstrom stage of stroke recovery with (1-6) scales


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Cerebrovascular accident, confirmed by a neurologist

Exclusion Criteria:

There are other diseases or behavioral restrictions that prevent exercise training, list below:

  1. dementia(MMSE<24), and etc.
  2. musculoskeletal disease
  3. Other exercise contraindications:

    1. unstable angina
    2. resting systolic blood pressure greater than 200 mmHg or diastolic blood pressure greater than 110 mmHg
    3. orthostatic blood pressure drop greater than 20 mmHg with symptoms
    4. Symptomatic severe aortic stenosis
    5. Acute systemic infection, accompanied by fever, body aches, or swollen lymph glands
    6. Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise
    7. Uncontrolled symptomatic heart failure
    8. High-degree atrioventricular blocks
    9. Acute myocarditis or pericarditis
    10. Acute pulmonary embolus or pulmonary infarction
    11. a recent significant change in the resting electrocardiogram suggesting significant ischemia,
    12. recent myocardial infarction (within 2 d), or other acute cardiac events
Contacts and Locations

Locations
Layout table for location information
Taiwan
Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital
Keelung, Taiwan, 204
Sponsors and Collaborators
Chang Gung Memorial Hospital
Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date January 6, 2020
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • neuro-function(cognitive function) [ Time Frame: after 36 session exercise training, up to 12 weeks ]
    cognitive function was measured by MMSE ( Mini-Mental State Examination)
  • neuro-function(limbs function) [ Time Frame: after 36 session exercise training, up to 12 weeks ]
    limbs function was measured by brunnstrom stage of stroke recovery with (1-6) scales
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation of Oxygen Uptake Efficiency Slope in Patients With Stroke
Official Title  ICMJE Validation of Oxygen Uptake Efficiency Slope in Patients With Stroke
Brief 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is prospective (for stroke), randomized, parallel-group (for exercise) design with a 1:1 allocation ratio.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Physical Fitness
  • Exercise Therapy
Intervention  ICMJE Behavioral: aerobic exercise therapy
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 Arms  ICMJE
  • No Intervention: usual neuro-rehab training
    stroke patient under usual neuro-rehab training
  • Experimental: Novel exercise training
    stroke patient under aerobic exercise training
    Intervention: Behavioral: aerobic exercise therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of Cerebrovascular accident, confirmed by a neurologist

Exclusion Criteria:

There are other diseases or behavioral restrictions that prevent exercise training, list below:

  1. dementia(MMSE<24), and etc.
  2. musculoskeletal disease
  3. Other exercise contraindications:

    1. unstable angina
    2. resting systolic blood pressure greater than 200 mmHg or diastolic blood pressure greater than 110 mmHg
    3. orthostatic blood pressure drop greater than 20 mmHg with symptoms
    4. Symptomatic severe aortic stenosis
    5. Acute systemic infection, accompanied by fever, body aches, or swollen lymph glands
    6. Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise
    7. Uncontrolled symptomatic heart failure
    8. High-degree atrioventricular blocks
    9. Acute myocarditis or pericarditis
    10. Acute pulmonary embolus or pulmonary infarction
    11. a recent significant change in the resting electrocardiogram suggesting significant ischemia,
    12. recent myocardial infarction (within 2 d), or other acute cardiac events
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960918
Other Study ID Numbers  ICMJE 201600569B0
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chang Gung Memorial Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP