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

NCT ID: NCT02855424

Last Updated: 2016-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2020-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

control

traditional rehabilitation merely, no ergocycling training

Group Type: NO_INTERVENTION

No interventions assigned to this group

the low-intensity exercise group

traditional rehabilitation plus the low-intensity ergocycling exercise training

Group Type: EXPERIMENTAL

the low-intensity exercise group

Intervention Type: OTHER

Totally 20-time training, frequency 2-6 time/week, total 20 times.

the moderate-intensity exercise group

traditional rehabilitation plus the moderate-intensity ergocycling exercise training

Group Type: EXPERIMENTAL

the moderate-intensity exercise group

Intervention Type: OTHER

Totally 20-time training, frequency 2-6 time/week,total 20 times.

Interventions

the low-intensity exercise group

Totally 20-time training, frequency 2-6 time/week, total 20 times.

Intervention Type: OTHER

the moderate-intensity exercise group

Totally 20-time training, frequency 2-6 time/week,total 20 times.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miao-Ju Hsu, PHD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Central Contacts

Miao-Ju Hsu, PHD

Role: CONTACT

mjhsu@kmu.edu.tw

886-7-3121101 ext. 2673

Other Identifiers

KUMHIRB-F(II)-2016002

Identifier Type: -

Identifier Source: org_study_id