MOVING - MOtiVation, INtervention and Vascular chanGe

NCT ID: NCT01919632

Last Updated: 2015-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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).

Conditions

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Endothelial Function (Reactive Hyperemia)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Lifestyle

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.

Group Type EXPERIMENTAL

health-behavior seminar and endurance exercise

Intervention Type BEHAVIORAL

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.

Interventions

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health-behavior seminar and endurance exercise

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Moving - ab jetzt gesund GmbH

UNKNOWN

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Halle, Prof.

Role: STUDY_CHAIR

Klinikum rechts der Isar, Department of Prevention and Sports medicine, Technische Universität München

Locations

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Klinikum rechts der Isar, Technische Universität München

Munich, Bavaria, Germany

Site Status

BP Lingen

Lingen, Emsland, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 36949505 (View on PubMed)

Other Identifiers

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2555/09

Identifier Type: -

Identifier Source: org_study_id

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