MOVING – MOtiVation, INtervention and Vascular chanGe

Overview

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).

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2013

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).

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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
  • 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
  • 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
  • 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
  • Health related quality of life (HRQoL)
    • Time Frame: after 0 month (V1) and 12 month (V3)
    • questionnaire
  • AI (Augmentation Index)
    • Time Frame: after 0 month, 3 month, 12 month
    • Vascular function: Change from baseline in AI (Augmentation Index) at 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Technical University of Munich
  • Collaborator
    • Moving – ab jetzt gesund GmbH
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Martin Halle, Prof., Study Chair, Klinikum rechts der Isar, Department of Prevention and Sports medicine, Technische Universität München

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