Clinical trial NCT01919632: MOVING - MOtiVation, INtervention and Vascular chanGe
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Function (Reactive Hyperemia)
Keywords: lifestyle
physical activity
endothelial function
cardiovascular
occupational
prevention
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Moving - ab jetzt gesund GmbH
First posted: 2013-08-09
Enrollment: 330
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in RHI (Reactive Hyperemia Index)
timeFrame: after 0 months (V1), 3 months (V2), 12 months (V3)
Secondary outcomes:
measure: Exercise capacity (Watt/kg)
timeFrame: after 0 month (V1) and after 12 month (V3)
measure: CAVI (Cardio ankle vascular index)
timeFrame: after 0 months (V1), 3 months (V2), 12 months (V3)
measure: Anthropometric parameters (see description)
timeFrame: after 0 months (V1), 3 months (V2), 12 months (V3)
measure: Inflammatory and metabolic parameters from blood samples (see description)
timeFrame: after 0 month (V1), 3 month (V2), 12 month (V3)
measure: Health related quality of life (HRQoL)
timeFrame: after 0 month (V1) and 12 month (V3)
measure: AI (Augmentation Index)
timeFrame: after 0 month, 3 month, 12 month
measure: ABI (Ankle-Brachial-Index)
timeFrame: after 0 month, 3 month, 12 month
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar, Technische Universität München
state: Bavaria
city: Lingen
country: Germany
facility: BP Lingen
state: Emsland
Study officials:
affiliation: Klinikum rechts der Isar, Department of Prevention and Sports medicine, Technische Universität München
name: Martin Halle, Prof.
role: STUDY_CHAIR
References: