Exercise Training on Metabolic Syndrome Severity in Employees

Study Overview
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Brief Summary
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Hypothesis: An occupational 6 months physical exercise training will lead to better health behaviour and improve the severity of the metabolic syndrome. 312 subjects will be assigned to either an intervention or a waiting-control-group. The intervention group will receive instructions with the aim to perform 150 min exercise training per week. Exercise consists of endurance, strength and coordination training. A feedback system guided by sports scientists will be installed for all subjects in the intervention group using activity monitoring (wearable). After 6 months training subjects from the intervention group will be assigned to one of the following groups for follow-up observation from month 6 to months 12: training with personal/individual feedback from sport scientist training with automated feedback using activity monitoring Tools (wearable) training without further feedback Subjects assigned to the control group will be provided with information on low intensity motion exercises. After 6 months in the control group subjects will be provided with the same exercise intervention as the intervention for a duration of 6 months. Study visits will be conducted at month 0, month 6, month 12, and a long-term follow-up at month 24..

Official Title
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Effects of a Workplace Health Service Program in Employees With Diagnosed Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Exercise training group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3 out of 5 parameters of the metabolic syndrome Exclusion Criteria: ongoing participation in occupational health service clinical relevant acute or chronic infections pregnancy surgery dating back less than 8 weeks artificial joint replacement dating back less than 6 months tumor disease dating back less than 5 years every other disease or relevant functional disorder not allowing to participate in regular physical exercise

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise training group<br>The intervention group will be encouraged to perform 150 min of exercise training per week for 6 months. Subjects will be provided with individual feedback and exercise Training prescriptions. After month 6 subjects will be randomized to three different groups for follow-up observation. | Behavioral: Exercise training group<br>* Exercise training will consist of 3 - 6 sessions per week and will cumulate in 150 min net exercise time per week. Heart rates during exercise sessions will be monitored with the aim of physical activities at moderate-intensity. Exercises will be individualized to reach the best possible improvements to the cardiovascular and musculoskeletal system. Possible disciples will include but are not limited to: cycling, rowing (ergometer), swimming, walking, nordic-walking, running, arm-cycle-ergometer or cross-trainer as well as fitness courses offered from occupational or private providers. Everyday activities which reach an effective heart rate range can account for exercise training on a home-based basis . Advise on complementary individual strength and coordination exercises will be added to the training program. A nutrition analyses will be completed by every subject to account for special needs of the metabolic syndrome.<br>|
| No Intervention: Waiting-control group<br>The control group will be provided with general informations on a healthy lifestyle. After 6 months wait-list-control months subjects will receive the guided exercise training intervention for 6 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Metabolic Syndrome (MetS) -Z-score | Z-Score (arbitrary unit, ranging from -2 to 2), assessed and calculated from the 5 established components of the metabolic syndrome: triglycerides, HDL cholesterol, fasting glucose, waist circumference, and systolic blood pressure. | 6 months 12 months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Work-Ability-Index (WAI) | score of WAI questionnaire, (Outcome work ability score: Minimum 1 Point, Maximum 49 Points) | 6 months, 12 months, 24 months | 
| Change from baseline in Health-related quality of live: score of SF36 questionnaire | score of SF36 questionnaire (outcomes: physical component score: Minimum 1 Point, Maximum 100 Points, mental component score: Minimum 1 Point, Maximum 100 Points) | 6 months, 12 months, 24 months | 
| Change from baseline in Pmax | Maximum workload reached in an graded exercise test (watt/kg Body Weight). | 6 months | 
| Change from baseline in Body weight | kg | 6 months | 
| Change from baseline in body composition | fat mass (kg), fat free mass (kg), visceral fat mass (kg) | 6 months, 12 months, 24 months | 
| Change from baseline in adherence to training program | percentage (%) of time (150 min per week) spend on exercising (minutes) | 6 months, 12 months, 24 months | 
| Change from baseline in Anxiety- and depression severity | Hospital Anxiety and Depression Scale, (outcomes: amxiety severity: Minimum 1 Point, Maximum 21 Points, Depression severity: Minimum 1 Point, Maximum 21 Points) | 6 months, 12 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic syndrome, exercise training, employees, workplace, operational health service