Exercise Training on Metabolic Syndrome Severity in Employees

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293264
• Other study ID #: RebVW
• Status: Completed
• Phase: N/A
• Start date: October 17, 2017
• Est. completion date: July 8, 2023

Study information

• Verified date: September 2023
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: July 8, 2023
• Est. primary completion date: December 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Germany	HannoverMS	Hannover	Lower Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	Volkswagen AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change from baseline in Pmax	Maximum workload reached in an graded exercise test (watt/kg Body Weight).	6 months
Secondary	Change from baseline in Body weight	kg	6 months
Secondary	Change from baseline in body composition	fat mass (kg), fat free mass (kg), visceral fat mass (kg)	6 months, 12 months, 24 months
Secondary	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
Secondary	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