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

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Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • The low-intensity exercise group Other
    Intervention Desc: Totally 20-time training, frequency 2-6 time/week, total 20 times.
    ARM 1: Kind: Experimental
    Label: the low-intensity exercise group
    Description: traditional rehabilitation plus the low-intensity ergocycling exercise training
  • The moderate-intensity exercise group Other
    Intervention Desc: Totally 20-time training, frequency 2-6 time/week,total 20 times.
    ARM 1: Kind: Experimental
    Label: the moderate-intensity exercise group
    Description: traditional rehabilitation plus the moderate-intensity ergocycling exercise training

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Factorial Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary changed value of symptom-limit exercise tolerance tests Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up No
Secondary changed activity of autonomic nervous system (ANS) Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up No
Secondary 10-meter walking test Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up No
Secondary changed score of the Barthel index Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up No
Secondary changed score of the Stroke-Specific Quality of Life Scale (SSQOL) Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up No
Secondary changed value of the Fugl-Meyer Assessment Lower Extremity (FMA-LE) Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up No
Secondary changed score of Multi-dimensional Fatigue Inventory Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up No
Secondary performance of cycling 4 weeks to 10 weeks for exercise completion No

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