Home Bicycle Exercise and Aerobic Capacity
Primary Purpose
Metabolic Cardiovascular Syndrome
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
bicycle exercise
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Cardiovascular Syndrome focused on measuring Metabolic syndrome, Diabetes, Muscle strength, Aerobic exercise, Bicycle, Brain-derived neurotrophic factor
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bicycle Exercise
Arm Description
Bicycle Exercise for 12 weeks
Outcomes
Primary Outcome Measures
Metabolic syndrome
Components of metabolic syndrome based on the modified Third Report of the National Cholesterol Education Program (NCEP) criteria
Secondary Outcome Measures
Muscle strength
A Biodex Isokinetic Dynamometer (Biodex Medical Systems, Inc., Shirley, New York, USA) was used to evaluate the muscle strength of the subjects
Brain-derived neurotrophic factor
Serum concentration of Brain-derived neurotrophic factor (enzyme immunoassay method, R&D Systems, Minneapolis, U.S.A.)
Arterial stiffness
Pulse wave velocity
Full Information
NCT ID
NCT02268292
First Posted
September 27, 2014
Last Updated
October 15, 2014
Sponsor
Taichung Veterans General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02268292
Brief Title
Home Bicycle Exercise and Aerobic Capacity
Official Title
The Effects of Home Bicycle Exercise Program on Hyperlipidemia, Hypertension, Blood Sugar Control, Muscle Strength and Aerobic Capacity
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taichung Veterans General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Cardiovascular Syndrome
Keywords
Metabolic syndrome, Diabetes, Muscle strength, Aerobic exercise, Bicycle, Brain-derived neurotrophic factor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bicycle Exercise
Arm Type
Experimental
Arm Description
Bicycle Exercise for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
bicycle exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Metabolic syndrome
Description
Components of metabolic syndrome based on the modified Third Report of the National Cholesterol Education Program (NCEP) criteria
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Muscle strength
Description
A Biodex Isokinetic Dynamometer (Biodex Medical Systems, Inc., Shirley, New York, USA) was used to evaluate the muscle strength of the subjects
Time Frame
12 weeks
Title
Brain-derived neurotrophic factor
Description
Serum concentration of Brain-derived neurotrophic factor (enzyme immunoassay method, R&D Systems, Minneapolis, U.S.A.)
Time Frame
12 weeks
Title
Arterial stiffness
Description
Pulse wave velocity
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
25682570
Citation
Tsai SW, Chan YC, Liang F, Hsu CY, Lee IT. Brain-derived neurotrophic factor correlated with muscle strength in subjects undergoing stationary bicycle exercise training. J Diabetes Complications. 2015 Apr;29(3):367-71. doi: 10.1016/j.jdiacomp.2015.01.014. Epub 2015 Feb 7.
Results Reference
derived
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Home Bicycle Exercise and Aerobic Capacity
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