Early Intervention With a Low-intensity Leg Cycling Exercise Program for Individuals After Stroke

Not Applicable

• Conditions: Stroke
• Interventions: Other: exercise

• Registration Number: NCT02437006
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

This is a two-stage study. In the first stage, 30 subjects with stroke (onset \> 2 weeks) are recruited, and they are assessed and recorded with clinical characteristics, sympathetic nerve testing, and twice symptom-limit exercise capacity tests. The second stage would recruited 90 subjects with stroke (onset\>2 weeks), and they are randomized to one of three groups (control, low-intensity, high-intensity). They are evaluated before and after the four-week interval with clinical characteristics and twice symptom-limit exercise capacity tests (baseline and after four-week training) .

Detailed Description

This is a two-stage study. In the first stage, 30 subjects with stroke (onset \> 2 weeks) are recruited, and they are assessed and recorded with sympathetic nerve testing, anthropometry, and twice symptom-limit exercise capacity tests.The second stage would recruited 90 subjects with stroke (onset\>2 weeks), and they are randomized to one of three groups. The control group undergoes traditional rehabilitation only, The low-intensity exercise group receives a low-intensity four-week cycle ergometry and traditional rehabilitation. The The high-intensity exercise group gets a high-intensity four-week cycle ergometry and traditional rehabilitation. They are evaluated by sympathetic tests, anthropometry, functional scales and activity questionnaires, and symptom-limit exercise capacity tests before and after the four-week training.

Study Timeline

• Status Verified: 2014-03
• Study Start: 2014-03
• Study First Submitted: 2015-03-31
• Study First Submitted QC: 2015-05-04
• Last Update Submitted: 2015-05-04
• Study First Posted: 2015-05-07
• Last Update Posted: 2015-05-07
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• stroke onset longer than two weeks,
• eligible for exercise testing by Doctor

Exclusion Criteria

• aphasia,
• apraxia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
High-intensity exercise	exercise	High-intensity exercise plus rehabilitation
Low-intensity exercise	exercise	Low-intensity exercise plus rehabilitation

Primary Outcome Measures

Name	Time	Method
change values of symptom-limit exercise capacity	baseline and after four-week training	value was showed by oxygen uptake (mL/kg/min)

Secondary Outcome Measures

Name	Time	Method
change values of sympathetic nerve tests	baseline and after four-week training	change value was measure by blood pressure (from lying to stand, mm-Hg) at baseline and after four weeks

Trial Locations

Locations (1)

Kaohsiung Medical University, College of Health Sciences; 🇨🇳 Kaohsiung, Taiwan