Endothelial Function (Reactive Hyperemia)MOVINGNCT01919632
MOVING - MOtiVation, INtervention and Vascular chanGe
A study testing health-behavior seminar and endurance exercise in people with Endothelial Function (Reactive Hyperemia), run by Technical University of Munich at 2 sites in Germany.
Trial summary
Background: The impact of demographic changes on workplace has increased the importance of effective occupational preventive health programs. The primary goal of these programs is the improvement of overall health status (and therefore increase productivity and decrease healthcare costs) of the increasingly older… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endothelial Function (Reactive Hyperemia)
- What is being tested?
- health-behavior seminar and endurance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2009to May 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Employees of the company British Petrol (BP) in Lingen, Germany
- men and woman of all age
- approval for being able to participate in physical activity
- existing, written agreement to study-participation with prior, detailed education
Who cannot join
- Acute or chronic disease of any kind, which does not allow participation in physical activity (missing approval of being able to participate in physical activity)
- Incompetent patient, who is not able to understand character, meaning and consequences of the study
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
BP Lingen
Lingen, Emsland, 49808
Klinikum rechts der Isar, Technische Universität München
Munich, Bavaria, 80992
About this study
Official title: MOVING - Einfluß Eines Lebensstilprogramms Auf Gefaeßzustand, Metabolisches Risikoprofil Und Leistungsfaehigkeit (MOVING - Influence of a Lifestyle Intervention Program on Vascular Condition, Metabolic Risk Profile and Physical Performance)
Background: The impact of demographic changes on workplace has increased the importance of effective occupational preventive health programs. The primary goal of these programs is the improvement of overall health status (and therefore increase productivity and decrease healthcare costs) of the increasingly older workforce through positive lifestyle behavior change.
A one- year preventive health behavior-change program for the employees of the company British Petrol (BP) shall be scientifically evaluated. The initial stage of the program consists of a health-behavior seminar and six weeks (twice a week for 90 minutes) of supervised endurance exercise (i.e. jogging, nordic walking, cycling or swimming) in groups. In the second phase of the program, the participants receive a recommendation to continue exercise regularly unsupervised for one year, and receive monthly supervised exercise training sessions. Clinical check-ups are performed at baseline (V1) at three months (V2) and at 12 months (V3).
Read the detailed description
The study will investigate the effect of one year of participation in a lifestyle- intervention- program on the participants' metabolic risk profile, exercise capacity and vascular health. A primary focus is on the endothelium, because poor endothelial health is a risk factor and prognostic indicator of atherosclerosis and cardiovascular events.
Hypothesis: One year of participation in endurance exercise (twice a week for 90 minutes) may positively influence endothelial health (RHI)
The primary aim:
change in endothelial function (reactive hyperemia index (RHI)) after one year.
Secondary aims:
Changes in other vascular parameters (AI: augmentation index, CAVI: Cardio ankle vascular index, ABI: ankle brachial index ), changes in anthropometric, inflammatory and metabolic parameters, exercise capacity (Watt/kg), physical activity, and health related quality of life (HRQoL).
- Being tested
- health-behavior seminar and endurance exercise
- Keywords
- lifestyle, physical activity, endothelial function, cardiovascular, occupational, prevention
- Medical subject headings
- Hyperemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health-behavior seminar and endurance exerciseBehavioural
The initial stage of the program consists of a health-behavior seminar and six weeks (twice a week for 90 minutes) of supervised endurance exercise (i.e. jogging, nordic walking, cycling or swimming) in groups. In the second phase of the program, the participants receive a recommendation to continue exercise regularly unsupervised for one year, and receive monthly supervised exercise training sessions.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle | Experimental | The initial stage of the program consists of a health-behavior seminar and six weeks (twice a week for 90 minutes) of supervised endurance exercise (i.e. (?) jogging, nordic walking, cycling or swimming) in groups. In the second phase of the program, the participants receive a recommendation to continue exercise regularly unsupervised for one year, and receive monthly supervised exercise training sessions. Receives: Behavioral: health-behavior seminar and endurance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in RHI (Reactive Hyperemia Index)
endothelial function
Measured: after 0 months (V1), 3 months (V2), 12 months (V3)
Secondary outcomes (7)
Exercise capacity (Watt/kg)
Changes from baseline in exercise capacity (Watt/kg) at 12 month
Measured: after 0 month (V1) and after 12 month (V3)
CAVI (Cardio ankle vascular index)
Vascular function: Change from baseline in CAVI (Cardio ankle vascular index) at 12 month
Measured: after 0 months (V1), 3 months (V2), 12 months (V3)
Anthropometric parameters (see description)
Changes from Baseline in systolic/diastolic blood pressure, weight, body-fat and waist-circumference at 12 month
Measured: after 0 months (V1), 3 months (V2), 12 months (V3)
Inflammatory and metabolic parameters from blood samples (see description)
Change from baseline in blood glucose, HbA1c, total cholesterol, HDL, LDL, triglycerides (metabolic parameters) and C-reactive protein (inflammatory parameters)at 12 month
Measured: after 0 month (V1), 3 month (V2), 12 month (V3)
Health related quality of life (HRQoL)
questionnaire
Measured: after 0 month (V1) and 12 month (V3)
AI (Augmentation Index)
Vascular function: Change from baseline in AI (Augmentation Index) at 12 month
Measured: after 0 month, 3 month, 12 month
ABI (Ankle-Brachial-Index)
Vascular function: Change from baseline in ABI (Ankle-Brachial-Index)at 12 month
Measured: after 0 month, 3 month, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startOct 2009
- Primary completionMay 2013
- Study completionMay 2013
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 Endothelial Function (Reactive Hyperemia)Studies 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Moving - ab jetzt gesund GmbH
- Responsible party
- Sponsor
- Investigators
- Martin Halle, Prof., Study chair, Klinikum rechts der Isar, Department of Prevention and Sports medicine, Technische Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919632
- Sponsor's protocol ID
- 2555/09
- Acronym
- MOVING
- Status last verified
- May 2015
- First submitted
- 5 Jul 2013
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Schaller N, Blume K, Hornig M, Senker L, Wolfarth B, Schuster T, Halle M, Esefeld K; MOVING (MOtiVation, INtervention and Vascular chanGe) study group. Occupational life-style programme over 12 months and changes of metabolic risk profile, vascular function, and physical fitness in blue-collar workers. J Occup Med Toxicol. 2023 Mar 22;18(1):4. doi: 10.1186/s12995-023-00370-w.
PubMed 36949505
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOVING - Einfluß Eines Lebensstilprogramms Auf Gefaeßzustand, Metabolisches Risikoprofil Und Leistungsfaehigkeit (MOVING - Influence of a Lifestyle Intervention Program on Vascular Condition, Metabolic Risk Profile and Physical Performance)
- ClinicalTrials.gov ID
- NCT01919632
- Acronym / sponsor ID
- MOVING / 2555/09
- Keywords
- lifestyle, physical activity, endothelial function, cardiovascular, occupational, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Moving - ab jetzt gesund GmbH
- Study start
- Oct 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 9 Aug 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.
Background: The impact of demographic changes on workplace has increased the importance of effective occupational preventive health programs. The primary goal of these programs is the improvement of overall health status (and therefore increase productivity and decrease healthcare costs) of the increasingly older workforce through positive lifestyle behavior change.
A one- year preventive health behavior-change program for the employees of the company British Petrol (BP) shall be scientifically evaluated. The initial stage of the program consists of a health-behavior seminar and six weeks (twice a week for 90 minutes) of supervised endurance exercise (i.e. jogging, nordic walking, cycling or swimming) in groups. In the second phase of the program, the participants receive a recommendation to continue exercise regularly unsupervised for one year, and receive monthly supervised exercise training sessions. Clinical check-ups are performed at baseline (V1) at three months (V2) and at 12 months (V3).
Detailed description
The study will investigate the effect of one year of participation in a lifestyle- intervention- program on the participants' metabolic risk profile, exercise capacity and vascular health. A primary focus is on the endothelium, because poor endothelial health is a risk factor and prognostic indicator of atherosclerosis and cardiovascular events.
Hypothesis: One year of participation in endurance exercise (twice a week for 90 minutes) may positively influence endothelial health (RHI)
The primary aim:
change in endothelial function (reactive hyperemia index (RHI)) after one year.
Secondary aims:
Changes in other vascular parameters (AI: augmentation index, CAVI: Cardio ankle vascular index, ABI: ankle brachial index ), changes in anthropometric, inflammatory and metabolic parameters, exercise capacity (Watt/kg), physical activity, and health related quality of life (HRQoL).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle | Experimental | Behavioral: health-behavior seminar and endurance exerciseThe initial stage of the program consists of a health-behavior seminar and six weeks (twice a week for 90 minutes) of supervised endurance exercise (i.e. (?) jogging, nordic walking, cycling or swimming) in groups. In the second phase of the program, the participants receive a recommendation to continue exercise regularly unsupervised for one year, and receive monthly supervised exercise training sessions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Employees of the company British Petrol (BP) in Lingen, Germany
- men and woman of all age
- approval for being able to participate in physical activity
- existing, written agreement to study-participation with prior, detailed education
Key exclusion criteria (2 listed)
- Acute or chronic disease of any kind, which does not allow participation in physical activity (missing approval of being able to participate in physical activity)
- Incompetent patient, who is not able to understand character, meaning and consequences of the study
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 |
|---|---|---|
| health-behavior seminar and endurance exerciseThe initial stage of the program consists of a health-behavior seminar and six weeks (twice a week for 90 minutes) of supervised endurance exercise (i.e. jogging, nordic walking, cycling or swimming) in groups. In the second phase of the program, the participants receive a recommendation to continue exercise regularly unsupervised for one year, and receive monthly supervised exercise training sessions. | Behavioural | Lifestyle |
Primary outcome
Change in RHI (Reactive Hyperemia Index)
Time frame: after 0 months (V1), 3 months (V2), 12 months (V3)
endothelial function
7 secondary outcomes
Exercise capacity (Watt/kg)
Time frame: after 0 month (V1) and after 12 month (V3)
CAVI (Cardio ankle vascular index)
Time frame: after 0 months (V1), 3 months (V2), 12 months (V3)
Anthropometric parameters (see description)
Time frame: after 0 months (V1), 3 months (V2), 12 months (V3)
Inflammatory and metabolic parameters from blood samples (see description)
Time frame: after 0 month (V1), 3 month (V2), 12 month (V3)
Health related quality of life (HRQoL)
Time frame: after 0 month (V1) and 12 month (V3)
AI (Augmentation Index)
Time frame: after 0 month, 3 month, 12 month
ABI (Ankle-Brachial-Index)
Time frame: after 0 month, 3 month, 12 month
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 12 May 2015.
- Derived from this study: PubMed 36949505Schaller N, Blume K, Hornig M, Senker L, Wolfarth B, Schuster T, Halle M, Esefeld K; MOVING (MOtiVation, INtervention and Vascular chanGe) study group. Occupational life-style programme over 12 months and changes of metabolic risk profile, vascular function, and physical fitness in blue-collar workers. J Occup Med Toxicol. 2023 Mar 22;18(1):4. doi: 10.1186/s12995-023-00370-w.
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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.
Martin Halle, Prof. study chair
Klinikum rechts der Isar, Department of Prevention and Sports medicine, Technische Universität München
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health-behavior seminar and endurance exercise in people with Endothelial Function (Reactive Hyperemia), run by Technical University of Munich at 2 sites in Germany.
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 4 inclusion and 2 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 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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.
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 in RHI (Reactive Hyperemia Index) (time frame: after 0 months (V1), 3 months (V2), 12 months (V3)). 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 NCT01919632, 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 12 May 2015; AzTrials last refreshed its copy on 26 Oct 2026.