Validation of Oxygen Uptake Efficiency Slope in Patients With Stroke

NCT03960918 | Unknown

• 1 other identifier: 201600569B0
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Physical Fitness; Exercise Therapy

Keywords

stroke; physical fitness; oxygen uptake efficiency slope (OUES)

Outcome Measures

Primary Outcomes (5)

• physical fitness (peak oxygen consumption)

  oxygen consumption in cc/min/kg measured by Carefusion(TM) in CPET

  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

  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

  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

  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

  after 36 session exercise training, up to 12 weeks

Secondary Outcomes (2)

• neuro-function(cognitive function)

  after 36 session exercise training, up to 12 weeks

• neuro-function(limbs function)

  after 36 session exercise training, up to 12 weeks

Study Arms (2)

usual neuro-rehab training

NO INTERVENTION

stroke patient under usual neuro-rehab training

Novel exercise training

EXPERIMENTAL

stroke patient under aerobic exercise training

Behavioral: aerobic exercise therapy

Interventions

aerobic exercise therapy BEHAVIORAL

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).

Novel exercise training

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Cerebrovascular accident, confirmed by a neurologist

You may not qualify if:

• 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,

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

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

Keelung, 204, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is prospective (for stroke), randomized, parallel-group (for exercise) design with a 1:1 allocation ratio.

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 23, 2019
• Study Start: January 1, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 31, 2020
• Last Updated: January 6, 2020

Record last verified: 2019-05

Locations

TW (1)