Exercise Training on Metabolic Syndrome Severity in Employees
NCT ID: NCT03293264
Last Updated: 2025-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
314 participants
INTERVENTIONAL
2017-10-17
2023-07-08
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Volkswagen AG
UNKNOWN
Hannover Medical School
OTHER
Responsible Party
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Principal Investigators
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Axel Haverich, Prof. Dr.
Role: STUDY_CHAIR
Hannover Medical School, Department of Cardiothoracic, Transplantation and Vascular Surgery (HTTG)
Uwe Tegtbur, Prof. Dr.
Role: STUDY_CHAIR
Hannover Medical School, Institute for Sports Medicine
Locations
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HannoverMS
Hanover, Lower Saxony, Germany
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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RebVW
Identifier Type: -
Identifier Source: org_study_id
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