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The Effect of Leg Cycling Exercise Program at Low or Moderate Intensity for Individuals With Subacute Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
the low-intensity exercise group
the moderate-intensity exercise group
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, exercise capacity

Eligibility Criteria

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

Inclusion Criteria:

  1. the first-ever stroke
  2. period of ischemic stroke onset is longer than two weeks, and less than six months, and the doctors agree with exercise training
  3. unilateral hemiplegia
  4. no obvious deficits of cognition. Scores of three items in the National Institutes of Health Stroke Scale are zero
  5. be willing to join this study and give their consent

Exclusion Criteria:

  1. aphasia
  2. orthopedic problems (severe arthritis), neurologic injury (eg. peripheral nerve injury) that can interfere with movement of the lower limb, or cannot sit independently
  3. with pace maker, severe cardiac arrhythmia, or heart failure
  4. 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    control

    the low-intensity exercise group

    the moderate-intensity exercise group

    Arm Description

    traditional rehabilitation merely, no ergocycling training

    traditional rehabilitation plus the low-intensity ergocycling exercise training

    traditional rehabilitation plus the moderate-intensity ergocycling exercise training

    Outcomes

    Primary Outcome Measures

    changed value of symptom-limit exercise tolerance tests
    One doctor and one therapist monitor the test. EKG and self-report are used.

    Secondary Outcome Measures

    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).
    10-meter walking test
    Time of performing the 10 meters is measured.
    changed score of the Barthel index
    Using Barthel index questionnaire
    changed score of the Stroke-Specific Quality of Life Scale (SSQOL)
    Using SSQOL questionnaire
    changed value of the Fugl-Meyer Assessment Lower Extremity (FMA-LE)
    Measure items of FMA-LE
    changed score of Multi-dimensional Fatigue Inventory
    Using Multi-dimensional Fatigue Inventory questionnaire
    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.

    Full Information

    First Posted
    July 6, 2016
    Last Updated
    August 4, 2016
    Sponsor
    Kaohsiung Medical University Chung-Ho Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02855424
    Brief Title
    The Effect of Leg Cycling Exercise Program at Low or Moderate Intensity for Individuals With Subacute Stroke
    Official Title
    The Effect of Leg Cycling Exercise Program at Low or Moderate Intensity for Individuals With Subacute Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kaohsiung Medical University Chung-Ho Memorial Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    stroke, exercise capacity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    traditional rehabilitation merely, no ergocycling training
    Arm Title
    the low-intensity exercise group
    Arm Type
    Experimental
    Arm Description
    traditional rehabilitation plus the low-intensity ergocycling exercise training
    Arm Title
    the moderate-intensity exercise group
    Arm Type
    Experimental
    Arm Description
    traditional rehabilitation plus the moderate-intensity ergocycling exercise training
    Intervention Type
    Other
    Intervention Name(s)
    the low-intensity exercise group
    Intervention Description
    Totally 20-time training, frequency 2-6 time/week, total 20 times.
    Intervention Type
    Other
    Intervention Name(s)
    the moderate-intensity exercise group
    Intervention Description
    Totally 20-time training, frequency 2-6 time/week,total 20 times.
    Primary Outcome Measure Information:
    Title
    changed value of symptom-limit exercise tolerance tests
    Description
    One doctor and one therapist monitor the test. EKG and self-report are used.
    Time Frame
    Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
    Secondary Outcome Measure Information:
    Title
    changed activity of autonomic nervous system (ANS)
    Description
    The frequency domain analysis (measure unit of activity of ANS) is used in two conditions (sit and calculate math; 5 minutes/each condition).
    Time Frame
    Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
    Title
    10-meter walking test
    Description
    Time of performing the 10 meters is measured.
    Time Frame
    Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
    Title
    changed score of the Barthel index
    Description
    Using Barthel index questionnaire
    Time Frame
    Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
    Title
    changed score of the Stroke-Specific Quality of Life Scale (SSQOL)
    Description
    Using SSQOL questionnaire
    Time Frame
    Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
    Title
    changed value of the Fugl-Meyer Assessment Lower Extremity (FMA-LE)
    Description
    Measure items of FMA-LE
    Time Frame
    Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
    Title
    changed score of Multi-dimensional Fatigue Inventory
    Description
    Using Multi-dimensional Fatigue Inventory questionnaire
    Time Frame
    Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
    Title
    performance of cycling
    Description
    the maximal power is recorded by a chip of the training bike continually during each training;2-6 times/week, total 20 times training.
    Time Frame
    4 weeks to 10 weeks for exercise completion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Miao-Ju Hsu, PHD
    Phone
    886-7-3121101
    Ext
    2673
    Email
    mjhsu@kmu.edu.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Miao-Ju Hsu, PHD
    Organizational Affiliation
    Kaohsiung Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Effect of Leg Cycling Exercise Program at Low or Moderate Intensity for Individuals With Subacute Stroke

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