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NCT Number: NCT01919632

MOVING - MOtiVation, INtervention and Vascular chanGe

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).

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Key information

Conditions

Endothelial Function (Reactive Hyperemia) Behavior Cardiovascular Diseases Hyperemia Motor Activity Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum rechts der Isar, Technische Universität München, Munich, Bavaria, Germany

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

health-behavior seminar and endurance exercise

Behavioral

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 outcomes

  1. Change in RHI (Reactive Hyperemia Index)

    Time frame: after 0 months (V1), 3 months (V2), 12 months (V3)

    endothelial function

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Health related quality of life (HRQoL)

    Time frame: after 0 month (V1) and 12 month (V3)

    questionnaire

  6. AI (Augmentation Index)

    Time frame: after 0 month, 3 month, 12 month

    Vascular function: Change from baseline in AI (Augmentation Index) at 12 month

  7. 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

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Moving - ab jetzt gesund GmbH

Registry information

Official study 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)

Acronym: MOVING

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Aug 9, 2013
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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