Cardiovascular DiseaseEarly Phase 1NCT01881139
Impact of Exercise Training on Cardiac Function in Man
A Early Phase 1 study testing exercise training in people with Cardiovascular Disease, run by No. 150 Central Hospital of the Chinese People Liberation Army at 1 site in China.
Trial summary
The purpose of this study is to monitor the impact of exercise training on cardiac functions and lipoprotein lipids. Read more about this study
- Who is it for?
- Ages 18 to 22 years, men only
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to May 2013
- Phase
- Early Phase 1
- 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 18 to 22 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- men
- age 18-25 years
- body mass index (BMI) 18-25 kg/m2
- no regular exercise
- no tobacco use
- no current use of prescribed medications
- no self-report of acute of chronic diseases
Who cannot join
- conditions that do not meet the inclusion criteria listed.
Trial locations and contacts
1 site in 1 country.
China1 site
No. 150 Central hospital of Chinese People's Liberation Army
Luoyang, Henan, 471000
About this study
Official title: Effects of Exercise Training on Cardiac Function and Lipid Metabolism in Mem 18-22 Year Old
The purpose of this study is to monitor the impact of exercise training on cardiac functions and lipoprotein lipids.
Read the detailed description
Exercise can increase the mass of left ventricle, which is also called athletic heart. Athletic heart is most frequently encountered as a pathological manifestation of cardiovascular disease, and the early determinants of athelitic remodeling in the general population are largely unknown. We will recruit 45 men aged 18-25 years who will run 5000 meters 2/day for 3 months. caridac function is examined by ECG and echocardiogram, blood pressure, lipoprotein, heart rate, body weight, cardiac troponin will be examined prior to exercise program and 3 months after exercise.
- Conditions
- Cardiovascular Disease
- Being tested
- exercise training
- Keywords
- Exercise, Lipid, Left ventricular, heart function
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| experimental 1 | Experimental | men with exercise training for 3 months Receives: Behavioral: exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of cardiac function at baseline to exercise training for 3 months
Measured: baseline to 3 months
Secondary outcomes (5)
change of lipoprotein at baseline to exercise training for 3 months
Measured: baseline to 3 months
change of heart rate at baseline to exercise training for 3 months
Measured: baseline to 3 months
Change of body weight at baseline to exercise training for 3 months
Measured: baseline to 3 months
change of cardiac troponin frome baseline to exercise training for 3 months
Measured: baselin to 3 months
Change of blood pressure from baseline to exercise training for 3 months
Measured: baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startDec 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- No. 150 Central Hospital of the Chinese People Liberation Army
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shenxu Wang, MD, Study director, No. 150 Central Hospital of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881139
- Sponsor's protocol ID
- 150CTSX002
- Status last verified
- Jun 2013
- First submitted
- 12 Jun 2013
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Training on Cardiac Function and Lipid Metabolism in Mem 18-22 Year Old
- ClinicalTrials.gov ID
- NCT01881139
- Acronym / sponsor ID
- 150CTSX002
- Conditions
- Cardiovascular Disease
- Keywords
- Exercise, Lipid, Left ventricular, heart function
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- No. 150 Central Hospital of the Chinese People Liberation ArmyOther government
- Study start
- Dec 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 19 Jun 2013 (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 purpose of this study is to monitor the impact of exercise training on cardiac functions and lipoprotein lipids.
Detailed description
Exercise can increase the mass of left ventricle, which is also called athletic heart. Athletic heart is most frequently encountered as a pathological manifestation of cardiovascular disease, and the early determinants of athelitic remodeling in the general population are largely unknown. We will recruit 45 men aged 18-25 years who will run 5000 meters 2/day for 3 months. caridac function is examined by ECG and echocardiogram, blood pressure, lipoprotein, heart rate, body weight, cardiac troponin will be examined prior to exercise program and 3 months after exercise.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental 1 | Experimental | Behavioral: exercise trainingmen with exercise training for 3 months |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- men
- age 18-25 years
- body mass index (BMI) 18-25 kg/m2
- no regular exercise
- no tobacco use
Key exclusion criteria (1 listed)
- conditions that do not meet the inclusion criteria listed.
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 |
|---|---|---|
| exercise training | Behavioural | experimental 1 |
Primary outcome
change of cardiac function at baseline to exercise training for 3 months
Time frame: baseline to 3 months
5 secondary outcomes
change of lipoprotein at baseline to exercise training for 3 months
Time frame: baseline to 3 months
change of heart rate at baseline to exercise training for 3 months
Time frame: baseline to 3 months
Change of body weight at baseline to exercise training for 3 months
Time frame: baseline to 3 months
change of cardiac troponin frome baseline to exercise training for 3 months
Time frame: baselin to 3 months
Change of blood pressure from baseline to exercise training for 3 months
Time frame: baseline to 3 months
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 19 Jun 2013.
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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.
Shenxu Wang, MD study director
No. 150 Central Hospital of PLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing exercise training in people with Cardiovascular Disease, run by No. 150 Central Hospital of the Chinese People Liberation Army at 1 site in China.
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 7 inclusion and 1 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 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
change of cardiac function at baseline to exercise training for 3 months (time frame: baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2013.