MOVING - MOtiVation, INtervention and Vascular chanGe (MOVING)

May 11, 2015 updated by: Technical University of Munich

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80992
        • Klinikum rechts der Isar, Technische Universität München
    • Emsland
      • Lingen, Emsland, Germany, 49808
        • BP Lingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in RHI (Reactive Hyperemia Index)
Time Frame: after 0 months (V1), 3 months (V2), 12 months (V3)
endothelial function
after 0 months (V1), 3 months (V2), 12 months (V3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise capacity (Watt/kg)
Time Frame: after 0 month (V1) and after 12 month (V3)
Changes from baseline in exercise capacity (Watt/kg) at 12 month
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)
Vascular function: Change from baseline in CAVI (Cardio ankle vascular index) at 12 month
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)
Changes from Baseline in systolic/diastolic blood pressure, weight, body-fat and waist-circumference at 12 month
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)
Change from baseline in blood glucose, HbA1c, total cholesterol, HDL, LDL, triglycerides (metabolic parameters) and C-reactive protein (inflammatory parameters)at 12 month
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)
questionnaire
after 0 month (V1) and 12 month (V3)
AI (Augmentation Index)
Time Frame: after 0 month, 3 month, 12 month
Vascular function: Change from baseline in AI (Augmentation Index) at 12 month
after 0 month, 3 month, 12 month
ABI (Ankle-Brachial-Index)
Time Frame: after 0 month, 3 month, 12 month
Vascular function: Change from baseline in ABI (Ankle-Brachial-Index)at 12 month
after 0 month, 3 month, 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Collaborators

Moving - ab jetzt gesund GmbH

Investigators

  • Study Chair: Martin Halle, Prof., Klinikum rechts der Isar, Department of Prevention and Sports medicine, Technische Universität München

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

July 5, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (ESTIMATE)

August 9, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2555/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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