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

August 4, 2016 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
traditional rehabilitation merely, no ergocycling training
Experimental: the low-intensity exercise group
traditional rehabilitation plus the low-intensity ergocycling exercise training
Other: the low-intensity exercise group
Totally 20-time training, frequency 2-6 time/week, total 20 times.
Experimental: the moderate-intensity exercise group
traditional rehabilitation plus the moderate-intensity ergocycling exercise training
Other: the moderate-intensity exercise group
Totally 20-time training, frequency 2-6 time/week,total 20 times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changed value of symptom-limit exercise tolerance tests
Time Frame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
One doctor and one therapist monitor the test. EKG and self-report are used.
Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changed activity of autonomic nervous system (ANS)
Time Frame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
The frequency domain analysis (measure unit of activity of ANS) is used in two conditions (sit and calculate math; 5 minutes/each condition).
Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
10-meter walking test
Time Frame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
Time of performing the 10 meters is measured.
Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
changed score of the Barthel index
Time Frame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
Using Barthel index questionnaire
Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
changed score of the Stroke-Specific Quality of Life Scale (SSQOL)
Time Frame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
Using SSQOL questionnaire
Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
changed value of the Fugl-Meyer Assessment Lower Extremity (FMA-LE)
Time Frame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
Measure items of FMA-LE
Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
changed score of Multi-dimensional Fatigue Inventory
Time Frame: Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
Using Multi-dimensional Fatigue Inventory questionnaire
Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up
performance of cycling
Time Frame: 4 weeks to 10 weeks for exercise completion
the maximal power is recorded by a chip of the training bike continually during each training;2-6 times/week, total 20 times training.
4 weeks to 10 weeks for exercise completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Principal Investigator: Miao-Ju Hsu, PHD, Kaohsiung Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

July 6, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUMHIRB-F(II)-2016002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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