- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02268292
Home Bicycle Exercise and Aerobic Capacity
October 15, 2014 updated by: TCVGH, Taichung Veterans General Hospital
The Effects of Home Bicycle Exercise Program on Hyperlipidemia, Hypertension, Blood Sugar Control, Muscle Strength and Aerobic Capacity
The subjects with MetS or type 2 diabetes were enrolled for this exercise-training program.
All participators underwent an indoor bicycle exercise for twelve weeks.
In addition to demographic data and biochemical tests were determined after an overnight fasting.
Extension of muscle strength was detected in the dominant lower extremity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This prospective open-labeled study was conducted in Taichung Veterans General Hospital.
The adult participants with metabolic syndrome and/or type 2 diabetes were enrolled.
MetS.
The procedures were fully explained to all subjects before the cardiopulmonary exercise test.
ll enrolled subjects received a scheduled twelve-week program for exercise-training program.
A commercially available bicycle with an indoor bicycle trainer are used as the home exercise training modality.
All medications were not allowed to be changed during the study.
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Phase 4
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
20 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult with metabolic syndrome or type 2 diabetes
Exclusion Criteria:
- hyperglycemic crisis or HbA1c > 12%;
- serum creatinine levels greater than 200 mmol/L;
- acute or chronic infectious diseases;
- limitations in the ability to undertake regular exercise
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bicycle Exercise
Bicycle Exercise for 12 weeks
|
All enrolled subjects received a scheduled twelve-week exercise program.
A commercially available bicycle (Giant CS800, Taichung, Taiwan) with an indoor bicycle stand (Giant Cyclotron Mag, Taichung, Taiwan) was used as the home exercise training modality.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic syndrome
Time Frame: 12 weeks
|
Components of metabolic syndrome based on the modified Third Report of the National Cholesterol Education Program (NCEP) criteria
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle strength
Time Frame: 12 weeks
|
A Biodex Isokinetic Dynamometer (Biodex Medical Systems, Inc., Shirley, New York, USA) was used to evaluate the muscle strength of the subjects
|
12 weeks
|
Brain-derived neurotrophic factor
Time Frame: 12 weeks
|
Serum concentration of Brain-derived neurotrophic factor (enzyme immunoassay method, R&D Systems, Minneapolis, U.S.A.)
|
12 weeks
|
Arterial stiffness
Time Frame: 12 weeks
|
Pulse wave velocity
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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, 2012
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
September 27, 2014
First Submitted That Met QC Criteria
October 15, 2014
First Posted (Estimate)
October 20, 2014
Study Record Updates
Last Update Posted (Estimate)
October 20, 2014
Last Update Submitted That Met QC Criteria
October 15, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SG12147
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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