Exercise Training on Metabolic Syndrome Severity in Employees

Overview

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..

Full Title of Study: “Effects of a Workplace Health Service Program in Employees With Diagnosed Metabolic Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Investigator)
  • Study Primary Completion Date: December 17, 2022

Interventions

  • Behavioral: Exercise training group
    • 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.

Arms, Groups and Cohorts

  • Experimental: Exercise training group
    • 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.
  • No Intervention: Waiting-control group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)
  • 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)
  • Change from baseline in Pmax
    • Time Frame: 6 months
    • Maximum workload reached in an graded exercise test (watt/kg Body Weight).
  • Change from baseline in Body weight
    • Time Frame: 6 months
    • kg
  • 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)
  • 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)
  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hannover Medical School
  • Collaborator
    • Volkswagen AG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Axel Haverich, Prof. Dr., Study Chair, Hannover Medical School, Department of Cardiothoracic, Transplantation and Vascular Surgery (HTTG)
    • Uwe Tegtbur, Prof. Dr., Study Chair, Hannover Medical School, Institute for Sports Medicine

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