MOVING - MOtiVation, INtervention and Vascular chanGe
- Conditions
- Endothelial Function (Reactive Hyperemia)
- Interventions
- Behavioral: health-behavior seminar and endurance exercise
- Registration Number
- NCT01919632
- Lead Sponsor
- Technical University of Munich
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lifestyle 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.
- Primary Outcome Measures
Name Time Method Change in RHI (Reactive Hyperemia Index) after 0 months (V1), 3 months (V2), 12 months (V3) endothelial function
- Secondary Outcome Measures
Name Time Method Health related quality of life (HRQoL) after 0 month (V1) and 12 month (V3) questionnaire
Exercise capacity (Watt/kg) 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) 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) 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) 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
AI (Augmentation Index) after 0 month, 3 month, 12 month Vascular function: Change from baseline in AI (Augmentation Index) at 12 month
ABI (Ankle-Brachial-Index) after 0 month, 3 month, 12 month Vascular function: Change from baseline in ABI (Ankle-Brachial-Index)at 12 month
Trial Locations
- Locations (2)
BP Lingen
🇩🇪Lingen, Emsland, Germany
Klinikum rechts der Isar, Technische Universität München
🇩🇪Munich, Bavaria, Germany