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Stepper Aerobic Training on Fitness, Disability, Inflammation and Thrombosis in Stroke Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02923765
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : January 31, 2020
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
Stroke rehabilitation of hemiplegics primarily lies in motor control and training of activities of daily life. Whole body aerobics is much less emphasized. Nonetheless, cardiopulmonary fitness of even ambulatory hemiparetics is only half compared with healthy people, which is prone to deconditioning. The present study aims to understand the efficacy of aerobic training in addition to the usual neuro-rehabilitation, including aerobic fitness, daily activities dependency, anti-inflammation and anti-thrombosis. This is a prospective and randomized design. The subjects will be recruited from the hospitalized patients in the rehabilitation ward of Chang Gung Memorial Hospital at Linkuo. 120 hemiplegic patients due to stroke will be enrolled and randomized into two groups: combined training (CT) and usual rehabilitation. Participants in CT will receive aerobics at moderate intensity in addition to the usual rehabilitation. The program has 35 minutes/session, 5 sessions/week and 4-5 weeks in total. A constant-power semi-recumbent stepper will be employed as the training modality. It uses bilateral reciprocal movement of the arm coupled with the opposite leg, which allows for a push and pull motion. Additional 20 healthy participants will also be recruited as the healthy control. Assessment before and after training includes: (I) graded cardiopulmonary exercise test using constant-load stepper. (II) Functional Independence Measure. (III) coagulation system assessment, using Thrombin generation assay and Ceveron alpha (Technoclone GmbH, Vienna, Austria) : Von Willebrand factor, tissue plasminogen activator, plasminogen activator inhibitor-1, D-dimer, factor VIII, etc. [the 1st year]; (IV) monocyte-platelet aggregation and its subtypes, using flow cytometry [the 2nd year]. ( V) systemic inflammation, platelet activation and prognostic biomarker:C-reactive protein, soluble P-selectin, asymmetric dimethylarginine, Lipoprotein-Associated Phospholipase A2, etc [the 3rd year]. Statistical analysis will use ANOVA with post-hoc, two-way repeated measure ANOVA, etc. The investigation will start after approval and end in 2019, July. We hope this investigation will establish a more comprehensive rehabilitation program for clinical application.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Other: Aerobic training by a stepper Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Stepper Aerobic Training on Cardiopulmonary Fitness, Disability, Systemic Inflammation and Thrombosis in Stroke Patients With Hemiplegia
Actual Study Start Date : October 11, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Active Comparator: combined training (CT)
additional aerobic training by a stepper : 35 minutes/session, 5 sessions/week and 4-5 weeks
Other: Aerobic training by a stepper
Aerobic training by a stepper: 35 minutes/session, 5 sessions/week and 4-5 weeks in total

No Intervention: usual rehabilitation (UR)
Usual rehabilitation, without additional aerobic training
No Intervention: healthy participant (HP)
healthy control

Primary Outcome Measures :
  1. Exercise capacity of all participants by Cardiopulmonary ExerciseTest (CPET) and Functional Independence Measure (FIM) [ Time Frame: three years ]

Secondary Outcome Measures :
  1. Thrombosis and Coagulation Activities of Blood Samples of All Participants by Flow Cytometry, [ Time Frame: three years ]
    detection of monocytes and platelets aggregation

  2. Thrombosis and Coagulation Activities of Blood Samples of All Participants by Dynamic TG Assay [ Time Frame: three years ]
    detection the amount and time of thrombin generation.

  3. Thrombosis and Coagulation Activities of Blood Samples of All Participants Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: three years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Clinical diagnosis of ischemic stroke
  • Must be able to ride the stepper
  • No cardiovascular disease in the healthy control group

Exclusion Criteria:

  • Resting heart rate greater than 100 beats per minute
  • Atrial fibrillation or flutter
  • Poor control of high blood pressure or diabetes
  • Patients with peripheral arterial occlusive disease
  • Patients with end-stage renal disease
  • Patients receiving anticoagulant therapy
  • Neurological instability
  • Confusion or cognitive dysfunction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02923765

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Contact: Shu-Chun Huang, MD, PhD +88633281200 ext 5156

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Shu-Chun Huang Recruiting
Taoyuan, Taiwan, 333
Contact: Shu-Chun Huang, MD, PhD    +88633281200 ext 5156   
Sponsors and Collaborators
Chang Gung Memorial Hospital
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Study Director: Shu-Chun Huang, MD, PhD Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital Identifier: NCT02923765    
Other Study ID Numbers: 201601026B0
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis