Clinical Trial: MOVING - MOtiVation, INtervention and Vascular chanGe

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: MOVING - Einfluß Eines Lebensstilprogramms Auf Gefaeßzustand, Metabolisches Risikoprofil Und Leistungsfaehigkeit (MOVING - Influence of a Lifestyle Intervention Program on Vascular Condition

Brief 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 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 Summary:

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).

Sponsor: Technische Universität München

Current Primary Outcome: Change in RHI (Reactive Hyperemia Index) [ Time Frame: after 0 months (V1), 3 months (V2), 12 months (V3) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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

Original Secondary Outcome: Same as current

Information By: Technische Universität München

Dates:
Date Received: July 5, 2013
Date Started: October 2009
Date Completion:
Last Updated: May 11, 2015
Last Verified: May 2015