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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
health-behavior seminar and endurance exercise
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

Other trials in Germany

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 groups in NCT01919632
Study groupRoleWhat they receive
LifestyleExperimentalThe 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.

  1. Change in RHI (Reactive Hyperemia Index)

    endothelial function

    Measured: after 0 months (V1), 3 months (V2), 12 months (V3)

Secondary outcomes (7)

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. Health related quality of life (HRQoL)

    questionnaire

    Measured: after 0 month (V1) and 12 month (V3)

  6. AI (Augmentation Index)

    Vascular function: Change from baseline in AI (Augmentation Index) at 12 month

    Measured: after 0 month, 3 month, 12 month

  7. 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.

  1. First posted9 Aug 2013 (estimated)
  2. Study startOct 2009
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

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)
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

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.

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