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

NCT02923765 | Completed DMC

• 1 other identifier: 201601026B0
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Exercise capacity of all participants by Cardiopulmonary ExerciseTest (CPET) and Functional Independence Measure (FIM)

  CPET

  three years

Secondary Outcomes (3)

• Thrombosis and Coagulation Activities of Blood Samples of All Participants by Flow Cytometry,

  three years

• Thrombosis and Coagulation Activities of Blood Samples of All Participants by Dynamic TG Assay

  three years

• Thrombosis and Coagulation Activities of Blood Samples of All Participants Enzyme-linked Immunosorbent Assay (ELISA)

  three years

Study Arms (3)

combined training (CT)

ACTIVE COMPARATOR

additional aerobic training by a stepper : 35 minutes/session, 5 sessions/week and 4-5 weeks

Other: Aerobic training by a stepper

usual rehabilitation (UR)

NO INTERVENTION

Usual rehabilitation, without additional aerobic training

healthy participant (HP)

NO INTERVENTION

healthy control

Interventions

Aerobic training by a stepper OTHER

Aerobic training by a stepper: 35 minutes/session, 5 sessions/week and 4-5 weeks in total

combined training (CT)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Shu-Chun Huang

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Shu-Chun Huang, MD, PhD

  Chang Gung Memorial Hospital

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 5, 2016
• Study Start: August 1, 2017
• Primary Completion: February 26, 2020
• Study Completion: September 30, 2020
• Last Updated: July 29, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)