Exercise Training on Metabolic Syndrome Severity in Employees

NCT03293264 | Completed

• 1 other identifier: RebVW
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

Brief 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..

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome; exercise training; employees; workplace; operational health service

Outcome Measures

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.

  6 months 12 months, 24 months

Secondary Outcomes (7)

• Change from baseline in Work-Ability-Index (WAI)

  6 months, 12 months, 24 months

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

  6 months, 12 months, 24 months

• Change from baseline in Pmax

  6 months

• Change from baseline in Body weight

  6 months

• Change from baseline in body composition

  6 months, 12 months, 24 months

Study Arms (2)

Exercise training group

EXPERIMENTAL

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

Waiting-control group

NO INTERVENTION

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

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.

Exercise training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• out of 5 parameters of the metabolic syndrome

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead
• Volkswagen AG: collaborator

Study Sites (1)

HannoverMS

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (5)

• 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.

  PMID: 36364823 BACKGROUND

• 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.

  PMID: 35144658 BACKGROUND

• 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.

  PMID: 34140456 BACKGROUND

• 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.

  PMID: 32625123 BACKGROUND

• 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.

  PMID: 31204284 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Axel Haverich, Prof. Dr.

  Hannover Medical School, Department of Cardiothoracic, Transplantation and Vascular Surgery (HTTG)

  STUDY CHAIR

• Uwe Tegtbur, Prof. Dr.

  Hannover Medical School, Institute for Sports Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 26, 2017
• Study Start: October 17, 2017
• Primary Completion: December 17, 2022
• Study Completion: July 8, 2023
• Last Updated: June 29, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)