MOVING - MOtiVation, INtervention and Vascular chanGe

Technical University of Munich

Status: Completed

Conditions: Endothelial Function (Reactive Hyperemia)

Treatments: Behavioral: health-behavior seminar and endurance exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01919632

2555/09

Details and patient eligibility

About

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 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).

Enrollment: 330 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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330 participants in 1 patient group

Lifestyle

Experimental group

Description:

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.

Treatment:

Behavioral: health-behavior seminar and endurance exercise