Clinical trial NCT03293264: Exercise Training on Metabolic Syndrome Severity in Employees
Official title: Effects of a Workplace Health Service Program in Employees With Diagnosed Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome
exercise training
employees
workplace
operational health service
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Volkswagen AG
First posted: 2017-09-26
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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..


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Metabolic Syndrome (MetS) -Z-score
timeFrame: 6 months 12 months, 24 months
Secondary outcomes:
measure: Change from baseline in Work-Ability-Index (WAI)
timeFrame: 6 months, 12 months, 24 months
measure: Change from baseline in Health-related quality of live: score of SF36 questionnaire
timeFrame: 6 months, 12 months, 24 months
measure: Change from baseline in Pmax
timeFrame: 6 months
measure: Change from baseline in Body weight
timeFrame: 6 months
measure: Change from baseline in body composition
timeFrame: 6 months, 12 months, 24 months
measure: Change from baseline in adherence to training program
timeFrame: 6 months, 12 months, 24 months
measure: Change from baseline in Anxiety- and depression severity
timeFrame: 6 months, 12 months, 24 months
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: HannoverMS
state: Lower Saxony
Study officials:
affiliation: Hannover Medical School, Department of Cardiothoracic, Transplantation and Vascular Surgery (HTTG)
name: Axel Haverich, Prof. Dr.
role: STUDY_CHAIR
affiliation: Hannover Medical School, Institute for Sports Medicine
name: Uwe Tegtbur, Prof. Dr.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.