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Exercise Training on Metabolic Syndrome Severity in Employees

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03293264
Enrollment
314
Registered
2017-09-26
Start date
2017-10-17
Completion date
2023-07-08
Last updated
2025-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

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

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..

Interventions

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.

Sponsors

Volkswagen AG
CollaboratorUNKNOWN
Hannover Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in Metabolic Syndrome (MetS) -Z-score6 months 12 months, 24 monthsZ-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.

Secondary

MeasureTime frameDescription
Change from baseline in Health-related quality of live: score of SF36 questionnaire6 months, 12 months, 24 monthsscore of SF36 questionnaire (outcomes: physical component score: Minimum 1 Point, Maximum 100 Points, mental component score: Minimum 1 Point, Maximum 100 Points)
Change from baseline in Pmax6 monthsMaximum workload reached in an graded exercise test (watt/kg Body Weight).
Change from baseline in Body weight6 monthskg
Change from baseline in Work-Ability-Index (WAI)6 months, 12 months, 24 monthsscore of WAI questionnaire, (Outcome work ability score: Minimum 1 Point, Maximum 49 Points)
Change from baseline in adherence to training program6 months, 12 months, 24 monthspercentage (%) of time (150 min per week) spend on exercising (minutes)
Change from baseline in Anxiety- and depression severity6 months, 12 months, 24 monthsHospital Anxiety and Depression Scale, (outcomes: amxiety severity: Minimum 1 Point, Maximum 21 Points, Depression severity: Minimum 1 Point, Maximum 21 Points)
Change from baseline in body composition6 months, 12 months, 24 monthsfat mass (kg), fat free mass (kg), visceral fat mass (kg)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026