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Exercise Training on Metabolic Syndrome Severity in Employees

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exercise training group
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Metabolic Syndrome focused on measuring metabolic syndrome, exercise training, employees, workplace, operational health service

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HannoverMS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise training group

Waiting-control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline in Work-Ability-Index (WAI)
score of WAI questionnaire, (Outcome work ability score: Minimum 1 Point, Maximum 49 Points)
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)
Change from baseline in Pmax
Maximum workload reached in an graded exercise test (watt/kg Body Weight).
Change from baseline in Body weight
kg
Change from baseline in body composition
fat mass (kg), fat free mass (kg), visceral fat mass (kg)
Change from baseline in adherence to training program
percentage (%) of time (150 min per week) spend on exercising (minutes)
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)

Full Information

First Posted
September 15, 2017
Last Updated
September 19, 2023
Sponsor
Hannover Medical School
Collaborators
Volkswagen AG
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1. Study Identification

Unique Protocol Identification Number
NCT03293264
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
December 17, 2022 (Actual)
Study Completion Date
July 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hannover Medical School
Collaborators
Volkswagen AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
metabolic syndrome, exercise training, employees, workplace, operational health service

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
314 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise training group
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting-control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise training group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Metabolic Syndrome (MetS) -Z-score
Description
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
Secondary Outcome Measure Information:
Title
Change from baseline in Work-Ability-Index (WAI)
Description
score of WAI questionnaire, (Outcome work ability score: Minimum 1 Point, Maximum 49 Points)
Time Frame
6 months, 12 months, 24 months
Title
Change from baseline in Health-related quality of live: score of SF36 questionnaire
Description
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
Title
Change from baseline in Pmax
Description
Maximum workload reached in an graded exercise test (watt/kg Body Weight).
Time Frame
6 months
Title
Change from baseline in Body weight
Description
kg
Time Frame
6 months
Title
Change from baseline in body composition
Description
fat mass (kg), fat free mass (kg), visceral fat mass (kg)
Time Frame
6 months, 12 months, 24 months
Title
Change from baseline in adherence to training program
Description
percentage (%) of time (150 min per week) spend on exercising (minutes)
Time Frame
6 months, 12 months, 24 months
Title
Change from baseline in Anxiety- and depression severity
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Haverich, Prof. Dr.
Organizational Affiliation
Hannover Medical School, Department of Cardiothoracic, Transplantation and Vascular Surgery (HTTG)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Uwe Tegtbur, Prof. Dr.
Organizational Affiliation
Hannover Medical School, Institute for Sports Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
HannoverMS
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
30625
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34140456
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.
Results Reference
derived
PubMed Identifier
32625123
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.
Results Reference
derived
PubMed Identifier
31204284
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.
Results Reference
derived

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Exercise Training on Metabolic Syndrome Severity in Employees

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