Exercise TherapyNCT02260232
Worksite Exercise Intervention Effects on Cardiovascular Disease Risk Factors and Physical Activity Levels Among Healthy Employees
A study testing exercise training in people with Exercise Therapy, run by Universidad Europea de Madrid.
Trial summary
Objective: To investigate the effects of a one-year worksite individual exercise intervention on lifestyle-related modifiable health risks, physical capacity and work performance. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Therapy
- What is being tested?
- exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Sep 2012
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Working in ASISA company, middle-age (20-60)
Who cannot join
- No medical condition contraindicating exercise participation
About this study
Objective: To investigate the effects of a one-year worksite individual exercise intervention on lifestyle-related modifiable health risks, physical capacity and work performance.
Methods: Two hundred ninety-five employees volunteered to participate (n=191 women, n=104 men), aged 38 ± 8 years and body mass index (BMI), 24.71 ± 3.79. Measures of physical activity levels were assessed by the long self-administrated version of the International Physical Activity Questionnaire-Long Form (IPAQ-L), and all subjects performed a maximal cardiopulmonary treadmill graded exercise test. Blood samples and anthropometry measures were collected from participants at baseline survey, at 6 months and 1-year after. Components of the program included supervised moderate to high intensity cardiorespiratory exercise, resistance training, and flexibility.
- Conditions
- Exercise Therapy
- Being tested
- exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingOther
| Study group | Role | What they receive |
|---|---|---|
| exercise intervention | Experimental | Components of the program included supervised moderate to high intensity cardiorespiratory exercise, resistance training, and flexibility. Receives: Other: exercise training |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire-Long Form (IPAQ-L)
Measured: 1 week
Graded cardiorespiratory fitness exercise test
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startJun 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TherapyStudies 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
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Garcia Lopez, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260232
- Sponsor's protocol ID
- UEM_ASISA_1
- Status last verified
- Oct 2014
- First submitted
- 6 Oct 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Worksite Exercise Intervention Effects on Cardiovascular Disease Risk Factors and Physical Activity Levels Among Healthy Employees
- ClinicalTrials.gov ID
- NCT02260232
- Acronym / sponsor ID
- UEM_ASISA_1
- Conditions
- Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 9 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.
Objective: To investigate the effects of a one-year worksite individual exercise intervention on lifestyle-related modifiable health risks, physical capacity and work performance.
Methods: Two hundred ninety-five employees volunteered to participate (n=191 women, n=104 men), aged 38 ± 8 years and body mass index (BMI), 24.71 ± 3.79. Measures of physical activity levels were assessed by the long self-administrated version of the International Physical Activity Questionnaire-Long Form (IPAQ-L), and all subjects performed a maximal cardiopulmonary treadmill graded exercise test. Blood samples and anthropometry measures were collected from participants at baseline survey, at 6 months and 1-year after. Components of the program included supervised moderate to high intensity cardiorespiratory exercise, resistance training, and flexibility.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise intervention | Experimental | Other: exercise trainingComponents of the program included supervised moderate to high intensity cardiorespiratory exercise, resistance training, and flexibility. |
| control | No intervention | – |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Working in ASISA company, middle-age (20-60)
Key exclusion criteria (1 listed)
- No medical condition contraindicating exercise participation
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 | Other | exercise intervention |
Primary outcome
International Physical Activity Questionnaire-Long Form (IPAQ-L)
Time frame: 1 week
Graded cardiorespiratory fitness exercise test
Time frame: 1 week
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 9 Oct 2014.
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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 study testing exercise training in people with Exercise Therapy, run by Universidad Europea de Madrid.
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 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 9 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.
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?
International Physical Activity Questionnaire-Long Form (IPAQ-L) (time frame: 1 week). The study lists 2 primary outcomes in all. 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 9 Oct 2014; AzTrials last refreshed its copy on 6 Nov 2026.