MOVING - MOtiVation, INtervention and Vascular chanGe (MOVING)
Primary Purpose
Endothelial Function (Reactive Hyperemia)
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
health-behavior seminar and endurance exercise
Sponsored by
About this trial
This is an interventional prevention trial for Endothelial Function (Reactive Hyperemia) focused on measuring lifestyle, physical activity, endothelial function, cardiovascular, occupational, prevention
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
Sites / Locations
- Klinikum rechts der Isar, Technische Universität München
- BP Lingen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lifestyle
Arm 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.
Outcomes
Primary Outcome Measures
Change in RHI (Reactive Hyperemia Index)
endothelial function
Secondary Outcome Measures
Exercise capacity (Watt/kg)
Changes from baseline in exercise capacity (Watt/kg) at 12 month
CAVI (Cardio ankle vascular index)
Vascular function: Change from baseline in CAVI (Cardio ankle vascular index) at 12 month
Anthropometric parameters (see description)
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)
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)
questionnaire
AI (Augmentation Index)
Vascular function: Change from baseline in AI (Augmentation Index) at 12 month
ABI (Ankle-Brachial-Index)
Vascular function: Change from baseline in ABI (Ankle-Brachial-Index)at 12 month
Full Information
NCT ID
NCT01919632
First Posted
July 5, 2013
Last Updated
May 11, 2015
Sponsor
Technical University of Munich
Collaborators
Moving - ab jetzt gesund GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01919632
Brief Title
MOVING - MOtiVation, INtervention and Vascular chanGe
Acronym
MOVING
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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
Collaborators
Moving - ab jetzt gesund GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Function (Reactive Hyperemia)
Keywords
lifestyle, physical activity, endothelial function, cardiovascular, occupational, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
330 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
health-behavior seminar and endurance exercise
Intervention 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.
Primary Outcome Measure Information:
Title
Change in RHI (Reactive Hyperemia Index)
Description
endothelial function
Time Frame
after 0 months (V1), 3 months (V2), 12 months (V3)
Secondary Outcome Measure Information:
Title
Exercise capacity (Watt/kg)
Description
Changes from baseline in exercise capacity (Watt/kg) at 12 month
Time Frame
after 0 month (V1) and after 12 month (V3)
Title
CAVI (Cardio ankle vascular index)
Description
Vascular function: Change from baseline in CAVI (Cardio ankle vascular index) at 12 month
Time Frame
after 0 months (V1), 3 months (V2), 12 months (V3)
Title
Anthropometric parameters (see description)
Description
Changes from Baseline in systolic/diastolic blood pressure, weight, body-fat and waist-circumference at 12 month
Time Frame
after 0 months (V1), 3 months (V2), 12 months (V3)
Title
Inflammatory and metabolic parameters from blood samples (see description)
Description
Change from baseline in blood glucose, HbA1c, total cholesterol, HDL, LDL, triglycerides (metabolic parameters) and C-reactive protein (inflammatory parameters)at 12 month
Time Frame
after 0 month (V1), 3 month (V2), 12 month (V3)
Title
Health related quality of life (HRQoL)
Description
questionnaire
Time Frame
after 0 month (V1) and 12 month (V3)
Title
AI (Augmentation Index)
Description
Vascular function: Change from baseline in AI (Augmentation Index) at 12 month
Time Frame
after 0 month, 3 month, 12 month
Title
ABI (Ankle-Brachial-Index)
Description
Vascular function: Change from baseline in ABI (Ankle-Brachial-Index)at 12 month
Time Frame
after 0 month, 3 month, 12 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Halle, Prof.
Organizational Affiliation
Klinikum rechts der Isar, Department of Prevention and Sports medicine, Technische Universität München
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum rechts der Isar, Technische Universität München
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80992
Country
Germany
Facility Name
BP Lingen
City
Lingen
State/Province
Emsland
ZIP/Postal Code
49808
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
MOVING - MOtiVation, INtervention and Vascular chanGe
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