Exercise Training on Metabolic Syndrome Severity in Employees
- Conditions
- Metabolic Syndrome
- Interventions
- Behavioral: Exercise training group
- Registration Number
- NCT03293264
- Lead Sponsor
- Hannover Medical School
- 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..
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 314
- 3 out of 5 parameters of the metabolic syndrome
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise training group 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.
- Primary Outcome Measures
Name Time Method Change from baseline in Metabolic Syndrome (MetS) -Z-score 6 months 12 months, 24 months 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.
- Secondary Outcome Measures
Name Time Method Change from baseline in Pmax 6 months Maximum workload reached in an graded exercise test (watt/kg Body Weight).
Change from baseline in Anxiety- and depression severity 6 months, 12 months, 24 months Hospital 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 adherence to training program 6 months, 12 months, 24 months percentage (%) of time (150 min per week) spend on exercising (minutes)
Change from baseline in Work-Ability-Index (WAI) 6 months, 12 months, 24 months score of WAI questionnaire, (Outcome work ability score: Minimum 1 Point, Maximum 49 Points)
Change from baseline in Body weight 6 months kg
Change from baseline in Health-related quality of live: score of SF36 questionnaire 6 months, 12 months, 24 months score 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 body composition 6 months, 12 months, 24 months fat mass (kg), fat free mass (kg), visceral fat mass (kg)
Trial Locations
- Locations (1)
HannoverMS
🇩🇪Hannover, Lower Saxony, Germany