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OpenTrials
Completed

NCT Number: NCT03293264

Exercise Training on Metabolic Syndrome Severity in Employees

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..

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HannoverMS

Hanover, Lower Saxony, 30625, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Exercise training group

Behavioral

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.

Primary outcomes

  1. Change from baseline in Metabolic Syndrome (MetS) -Z-score

    Time frame: 6 months 12 months, 24 months

    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.

Secondary outcomes

  1. Change from baseline in Work-Ability-Index (WAI)

    Time frame: 6 months, 12 months, 24 months

    score of WAI questionnaire, (Outcome work ability score: Minimum 1 Point, Maximum 49 Points)

  2. Change from baseline in Health-related quality of live: score of SF36 questionnaire

    Time frame: 6 months, 12 months, 24 months

    score of SF36 questionnaire (outcomes: physical component score: Minimum 1 Point, Maximum 100 Points, mental component score: Minimum 1 Point, Maximum 100 Points)

  3. Change from baseline in Pmax

    Time frame: 6 months

    Maximum workload reached in an graded exercise test (watt/kg Body Weight).

  4. Change from baseline in Body weight

    Time frame: 6 months

    kg

  5. Change from baseline in body composition

    Time frame: 6 months, 12 months, 24 months

    fat mass (kg), fat free mass (kg), visceral fat mass (kg)

  6. Change from baseline in adherence to training program

    Time frame: 6 months, 12 months, 24 months

    percentage (%) of time (150 min per week) spend on exercising (minutes)

  7. Change from baseline in Anxiety- and depression severity

    Time frame: 6 months, 12 months, 24 months

    Hospital Anxiety and Depression Scale, (outcomes: amxiety severity: Minimum 1 Point, Maximum 21 Points, Depression severity: Minimum 1 Point, Maximum 21 Points)

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Collaborators

  • Volkswagen AG

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Sep 26, 2017
Registry last updated
Jun 29, 2025

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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