Exercise Training on Metabolic Syndrome Severity in Employees

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

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..

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Behavioral: Exercise training group

• Study Type: Interventional
• Enrollment (Actual): 314
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Lower Saxony
    • Hannover, Lower Saxony, Germany, 30625
      • HannoverMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Work-Ability-Index (WAI)	score of WAI questionnaire, (Outcome work ability score: Minimum 1 Point, Maximum 49 Points)	6 months, 12 months, 24 months
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)	6 months, 12 months, 24 months
Change from baseline in Pmax	Maximum workload reached in an graded exercise test (watt/kg Body Weight).	6 months
Change from baseline in Body weight	kg	6 months
Change from baseline in body composition	fat mass (kg), fat free mass (kg), visceral fat mass (kg)	6 months, 12 months, 24 months
Change from baseline in adherence to training program	percentage (%) of time (150 min per week) spend on exercising (minutes)	6 months, 12 months, 24 months
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)	6 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Collaborators: Volkswagen AG
• Investigators: Study Chair: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2017
• Primary Completion (Actual): December 17, 2022
• Study Completion (Actual): July 8, 2023

Study Registration Dates

• First Submitted: September 15, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: exercise training; metabolic syndrome; employees; workplace; operational health service
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: RebVW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No