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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02855424
• Other study ID #: KUMHIRB-F(II)-2016002
• Status: Not yet recruiting
• Phase: N/A
• First received: July 6, 2016
• Last updated: August 4, 2016
• Start date: August 2016
• Est. completion date: December 2020

Study information

• Verified date: June 2016
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Miao-Ju Hsu, PHD
• Phone: 886-7-3121101
• Email: mjhsu[@]kmu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: National Science Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• the low-intensity exercise group
Totally 20-time training, frequency 2-6 time/week, total 20 times.
• the moderate-intensity exercise group
Totally 20-time training, frequency 2-6 time/week,total 20 times.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changed value of symptom-limit exercise tolerance tests	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	No
Secondary	changed activity of autonomic nervous system (ANS)	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	No
Secondary	10-meter walking test	Time of performing the 10 meters is measured.	Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up	No
Secondary	changed score of the Barthel index	Using Barthel index questionnaire	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)	Using SSQOL questionnaire	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)	Measure items of FMA-LE	Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up	No
Secondary	changed score of Multi-dimensional Fatigue Inventory	Using Multi-dimensional Fatigue Inventory questionnaire	Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up	No
Secondary	performance of cycling	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	No