Metabolic Cardiovascular SyndromePhase 4NCT02268292
Home Bicycle Exercise and Aerobic Capacity
A Phase 4 study testing bicycle exercise in people with Metabolic Cardiovascular Syndrome, run by Taichung Veterans General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Metabolic Cardiovascular Syndrome
- What is being tested?
- bicycle exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Aug 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult with metabolic syndrome or type 2 diabetes
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Cardiovascular Syndrome
- Being tested
- bicycle exercise
- Keywords
- Metabolic syndrome, Diabetes, Muscle strength, Aerobic exercise, Bicycle, Brain-derived neurotrophic factor
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bicycle exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Bicycle Exercise | Experimental | Bicycle Exercise for 12 weeks Receives: Behavioral: bicycle exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic syndrome
Components of metabolic syndrome based on the modified Third Report of the National Cholesterol Education Program (NCEP) criteria
Measured: 12 weeks
Secondary outcomes (3)
Muscle strength
A Biodex Isokinetic Dynamometer (Biodex Medical Systems, Inc., Shirley, New York, USA) was used to evaluate the muscle strength of the subjects
Measured: 12 weeks
Brain-derived neurotrophic factor
Serum concentration of Brain-derived neurotrophic factor (enzyme immunoassay method, R\&D Systems, Minneapolis, U.S.A.)
Measured: 12 weeks
Arterial stiffness
Pulse wave velocity
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startAug 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Cardiovascular SyndromeStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TCVGH, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268292
- Sponsor's protocol ID
- SG12147
- Status last verified
- Oct 2014
- First submitted
- 27 Sep 2014
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25682570
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Home Bicycle Exercise Program on Hyperlipidemia, Hypertension, Blood Sugar Control, Muscle Strength and Aerobic Capacity
- ClinicalTrials.gov ID
- NCT02268292
- Acronym / sponsor ID
- SG12147
- Conditions
- Metabolic Cardiovascular Syndrome
- Keywords
- Metabolic syndrome, Diabetes, Muscle strength, Aerobic exercise, Bicycle, Brain-derived neurotrophic factor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bicycle Exercise | Experimental | Behavioral: bicycle exerciseBicycle Exercise for 12 weeks |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult with metabolic syndrome or type 2 diabetes
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bicycle exerciseAll 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. | Behavioural | Bicycle Exercise |
Primary outcome
Metabolic syndrome
Time frame: 12 weeks
Components of metabolic syndrome based on the modified Third Report of the National Cholesterol Education Program (NCEP) criteria
3 secondary outcomes
Muscle strength
Time frame: 12 weeks
Brain-derived neurotrophic factor
Time frame: 12 weeks
Arterial stiffness
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
- Derived from this study: PubMed 25682570Tsai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bicycle exercise in people with Metabolic Cardiovascular Syndrome, run by Taichung Veterans General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic syndrome (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02268292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2014.