CClinicalTrials.gg
CompletedNCT03293264Updated Jun 29, 2025

Exercise Training on Metabolic Syndrome Severity in Employees

An interventional study of Exercise training group in Metabolic Syndrome, sponsored by Hannover Medical School. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-29.

Sponsored by Hannover Medical School · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
314
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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..

02

Conditions studied

  • Metabolic Syndrome

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Keywords

  • metabolic syndrome
  • exercise training
  • employees
  • workplace
  • operational health service
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 3 out of 5 parameters of the metabolic syndrome

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
314 participants (actual)

Study arms

  • 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.

    Behavioral: Exercise training group

  • 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.

Interventions

  • BehavioralExercise 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months 12 months, 24 months

Secondary outcomes

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

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

    Time frame: 6 months, 12 months, 24 months

  2. 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)

    Time frame: 6 months, 12 months, 24 months

  3. Change from baseline in Pmax

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

    Time frame: 6 months

  4. Change from baseline in Body weight

    kg

    Time frame: 6 months

  5. Change from baseline in body composition

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

    Time frame: 6 months, 12 months, 24 months

  6. Change from baseline in adherence to training program

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

    Time frame: 6 months, 12 months, 24 months

  7. 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)

    Time frame: 6 months, 12 months, 24 months

06

Study locations

1 site
  • HannoverMS
    Hanover, Lower Saxony 30625, Germany
07

References and documents

Publications

  • Bayerle P, Haufe S, Kuck M, Protte G, Kerling A, Ewers S, Boeck HT, Sundermeier T, Ensslen R, Kahl KG, Haverich A, Tegtbur U, Nachbar L. The Impact of Body Weight Changes versus Exercise Capacity Changes on Health-Related Factors following a Lifestyle Intervention in Employees with Metabolic Syndrome. Nutrients. 2022 Oct 29;14(21):4560. doi: 10.3390/nu14214560. PubMed 36364823 ↗
  • Bayerle P, Kerling A, Kuck M, Rolff S, Boeck HT, Sundermeier T, Ensslen R, Tegtbur U, Lauenstein D, Bothig D, Bara C, Hanke A, Terkamp C, Haverich A, Stiesch M, de Zwaan M, Haufe S, Nachbar L. Effectiveness of wearable devices as a support strategy for maintaining physical activity after a structured exercise intervention for employees with metabolic syndrome: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2022 Feb 10;14(1):24. doi: 10.1186/s13102-022-00409-1. PubMed 35144658 ↗
  • Haufe S, Hupa-Breier KL, Bayerle P, Boeck HT, Rolff S, Sundermeier T, Kerling A, Eigendorf J, Kuck M, Hanke AA, Ensslen R, Nachbar L, Lauenstein D, Bothig D, Hilfiker-Kleiner D, Stiesch M, Terkamp C, Wedemeyer H, Haverich A, Tegtbur U. Telemonitoring-Supported Exercise Training in Employees With Metabolic Syndrome Improves Liver Inflammation and Fibrosis. Clin Transl Gastroenterol. 2021 Jun 18;12(6):e00371. doi: 10.14309/ctg.0000000000000371. PubMed 34140456 ↗
  • Haufe S, Kahl KG, Kerling A, Protte G, Bayerle P, Stenner HT, Rolff S, Sundermeier T, Eigendorf J, Kuck M, Hanke AA, Keller-Varady K, Ensslen R, Nachbar L, Lauenstein D, Bothig D, Terkamp C, Stiesch M, Hilfiker-Kleiner D, Haverich A, Tegtbur U. Employers With Metabolic Syndrome and Increased Depression/Anxiety Severity Profit Most From Structured Exercise Intervention for Work Ability and Quality of Life. Front Psychiatry. 2020 Jun 18;11:562. doi: 10.3389/fpsyt.2020.00562. eCollection 2020. PubMed 32625123 ↗
  • Haufe S, Kerling A, Protte G, Bayerle P, Stenner HT, Rolff S, Sundermeier T, Kuck M, Ensslen R, Nachbar L, Lauenstein D, Bothig D, Bara C, Hanke AA, Terkamp C, Stiesch M, Hilfiker-Kleiner D, Haverich A, Tegtbur U. Telemonitoring-supported exercise training, metabolic syndrome severity, and work ability in company employees: a randomised controlled trial. Lancet Public Health. 2019 Jul;4(7):e343-e352. doi: 10.1016/S2468-2667(19)30075-1. Epub 2019 Jun 13. PubMed 31204284 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03293264
Lead sponsor
Hannover Medical School
Collaborators
Volkswagen AG
Responsible party
Sponsor
First posted
Sep 26, 2017
Start date
Oct 17, 2017
Primary completion
Dec 17, 2022
Completion
Jul 8, 2023
Last update
Jun 29, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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