An interventional study of Exercise training group in Metabolic Syndrome, sponsored by Hannover Medical School. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-29.
Sponsored by Hannover Medical School · Not applicable, Interventional, and Health services research
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:
Study visits will be conducted at month 0, month 6, month 12, and a long-term follow-up at month 24..
Exclusion Criteria:
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
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.
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.
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.
Time frame: 6 months 12 months, 24 months
Change from baseline in Work-Ability-Index (WAI)
score of WAI questionnaire, (Outcome work ability score: Minimum 1 Point, Maximum 49 Points)
Time frame: 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)
Time frame: 6 months, 12 months, 24 months
Change from baseline in Pmax
Maximum workload reached in an graded exercise test (watt/kg Body Weight).
Time frame: 6 months
Change from baseline in Body weight
kg
Time frame: 6 months
Change from baseline in body composition
fat mass (kg), fat free mass (kg), visceral fat mass (kg)
Time frame: 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)
Time frame: 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)
Time frame: 6 months, 12 months, 24 months
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Hannover Medical School