Back to resultsEarly Intervention With a Low-intensity Leg Cycling Exercise Program for Individuals After Stroke
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
exercise
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, exercise capacity
Eligibility Criteria
Inclusion Criteria:
- stroke onset longer than two weeks,
- eligible for exercise testing by Doctor
Exclusion Criteria:
- aphasia,
- apraxia
Sites / Locations
- Kaohsiung Medical University, College of Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
rehabilitation
Low-intensity exercise
High-intensity exercise
Arm Description
half an hour physical and half an hour occupational therapy in rehabilitation
Low-intensity exercise plus rehabilitation
High-intensity exercise plus rehabilitation
Outcomes
Primary Outcome Measures
change values of symptom-limit exercise capacity
value was showed by oxygen uptake (mL/kg/min)
Secondary Outcome Measures
change values of sympathetic nerve tests
change value was measure by blood pressure (from lying to stand, mm-Hg) at baseline and after four weeks
Full Information
NCT ID
NCT02437006
First Posted
March 31, 2015
Last Updated
May 4, 2015
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02437006
Brief Title
Early Intervention With a Low-intensity Leg Cycling Exercise Program for Individuals After Stroke
Official Title
Early Intervention With a Low-intensity Leg Cycling Exercise Program for Individuals After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, exercise capacity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rehabilitation
Arm Type
No Intervention
Arm Description
half an hour physical and half an hour occupational therapy in rehabilitation
Arm Title
Low-intensity exercise
Arm Type
Experimental
Arm Description
Low-intensity exercise plus rehabilitation
Arm Title
High-intensity exercise
Arm Type
Experimental
Arm Description
High-intensity exercise plus rehabilitation
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
cycle ergometry
Primary Outcome Measure Information:
Title
change values of symptom-limit exercise capacity
Description
value was showed by oxygen uptake (mL/kg/min)
Time Frame
baseline and after four-week training
Secondary Outcome Measure Information:
Title
change values of sympathetic nerve tests
Description
change value was measure by blood pressure (from lying to stand, mm-Hg) at baseline and after four weeks
Time Frame
baseline and after four-week training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stroke onset longer than two weeks,
eligible for exercise testing by Doctor
Exclusion Criteria:
aphasia,
apraxia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miao-Ju Hsu, PHD
Phone
88673121101
Ext
2673
Email
mjhsu@kmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miao-Ju Hsu, PHD
Organizational Affiliation
Kaohsiung Medical University, College of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University, College of Health Sciences
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miao-Ju Hsu, PHD
Phone
886-7-3121101
Ext
2673
Email
mjhsu@kmu.edu.tw
12. IPD Sharing Statement
Learn more about this trial
Early Intervention With a Low-intensity Leg Cycling Exercise Program for Individuals After Stroke
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