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Validation of Oxygen Uptake Efficiency Slope in Patients With Stroke

Primary Purpose

Stroke, Physical Fitness, Exercise Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
aerobic exercise therapy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, physical fitness, oxygen uptake efficiency slope (OUES)

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

usual neuro-rehab training

Novel exercise training

Arm Description

stroke patient under usual neuro-rehab training

stroke patient under aerobic exercise training

Outcomes

Primary Outcome Measures

physical fitness (peak oxygen consumption)
oxygen consumption in cc/min/kg measured by Carefusion(TM) in CPET
physical fitness (maximal cardiac output)
maximal cardiac output in L/min measured by NICOM(TM) in CPET
physical fitness(oxygen uptake efficiency slope)
oxygen uptake efficiency slope was calculated with oxygen consumption and workload in CPET
physical fitness (cerebral blood flow)
cerebral blood flow in cc/min measured by Near-Infrared spectrometry
physical fitness(limb muscle strength)
limb muscle strength was measured by manual muscle test with (0-5) scales

Secondary Outcome Measures

neuro-function(cognitive function)
cognitive function was measured by MMSE ( Mini-Mental State Examination)
neuro-function(limbs function)
limbs function was measured by brunnstrom stage of stroke recovery with (1-6) scales

Full Information

First Posted
May 17, 2019
Last Updated
January 3, 2020
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03960918
Brief Title
Validation of Oxygen Uptake Efficiency Slope in Patients With Stroke
Official Title
Validation of Oxygen Uptake Efficiency Slope in Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Physical Fitness, Exercise Therapy
Keywords
stroke, physical fitness, oxygen uptake efficiency slope (OUES)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is prospective (for stroke), randomized, parallel-group (for exercise) design with a 1:1 allocation ratio.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
usual neuro-rehab training
Arm Type
No Intervention
Arm Description
stroke patient under usual neuro-rehab training
Arm Title
Novel exercise training
Arm Type
Experimental
Arm Description
stroke patient under aerobic exercise training
Intervention Type
Behavioral
Intervention Name(s)
aerobic exercise therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
physical fitness (peak oxygen consumption)
Description
oxygen consumption in cc/min/kg measured by Carefusion(TM) in CPET
Time Frame
after 36 session exercise training, up to 12 weeks
Title
physical fitness (maximal cardiac output)
Description
maximal cardiac output in L/min measured by NICOM(TM) in CPET
Time Frame
after 36 session exercise training, up to 12 weeks
Title
physical fitness(oxygen uptake efficiency slope)
Description
oxygen uptake efficiency slope was calculated with oxygen consumption and workload in CPET
Time Frame
after 36 session exercise training, up to 12 weeks
Title
physical fitness (cerebral blood flow)
Description
cerebral blood flow in cc/min measured by Near-Infrared spectrometry
Time Frame
after 36 session exercise training, up to 12 weeks
Title
physical fitness(limb muscle strength)
Description
limb muscle strength was measured by manual muscle test with (0-5) scales
Time Frame
after 36 session exercise training, up to 12 weeks
Secondary Outcome Measure Information:
Title
neuro-function(cognitive function)
Description
cognitive function was measured by MMSE ( Mini-Mental State Examination)
Time Frame
after 36 session exercise training, up to 12 weeks
Title
neuro-function(limbs function)
Description
limbs function was measured by brunnstrom stage of stroke recovery with (1-6) scales
Time Frame
after 36 session exercise training, up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 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
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital
City
Keelung
ZIP/Postal Code
204
Country
Taiwan

12. IPD Sharing Statement

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Validation of Oxygen Uptake Efficiency Slope in Patients With Stroke

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