RepoMed (Medizinische Hochschule Hannover)

Haufe, Sven

Study Title: Effects of a physical activity intervention on metabolic syndrome severity in employees from the Volkswagen AG. 
Synopsis Version: 1.0 from 31.05.2017 
Principal Investigator: Prof. Dr. med. Uwe Tegtbur 
 
 
 
IRB Synopsis form non-AMG/non-MPG  1 / 4 V.1.2-20180323-1400 
IRB No. 
(issued by IRB)       
 
Study Protocol for non-Drug- and non-Medical Device Studies 
 
Address: 
Office of the ethic committee of Hannover Medical School (OE 9515)  
Carl-Neuberg-Straße 1 
30625 Hannover  
Phone: 0511 532 3443 / 9812 
Fax: 0511 532 163443 
Email: ethikkommission@mh-hannover.de 
 
1 Principal Investigator 
(Acad. title, name, affiliation) Prof. Dr. med. Uwe Tegtbur, Institute of Sports Medicine 
Prof. Dr. med. Axel Haverich, Dept. of Cardiac, Thoracic, Transplantation 
and Vascular Surgery 
2 Sub-Investigators 
(Acad. title, name, affiliation) Dr. Sven Haufe, Institute of Sports Medicine and Institute of Clinical 
Pharmacology 
Dr. med. Arno Kerling, Institute of Sports Medicine 
3 Statistician 
(Acad. title, name, Affiliation) Dr. Dietmar Böthig, Dept. of Cardiac, Thoracic, Transplantation and 
Vascular Surgery 
4 Title of Study Effects of a physical activity intervention on metabolic syndrome severity 
in employees from the Volkswagen AG. 
5 Medical Condition Metabolic syndrome 
6 Study Characteristics 
(Check all that apply) 
[X] prospective   [ ] retrospective 
[X] therapeutic   [ ] observational 
[ ] diagnostic    [ ] biobank/biomarker study 
[ ] prophylactic     
[X] monocentric    [ ] multicentric 
[X] open-label    [ ] blind    or    [ ] double-blind 
[X] parallel group comparison [X] randomized 
[ ] single arm    [ ] cross-over 
[ ] ionizing radiation (StrSchV) [ ] X-rays (RöV) 
[ ] other:       
7 Intervention 
(If not applicable note: n.a.) 
experimental group:                   supervised physical exercise training 
control group:                    waiting-control group 
duration of intervention per patient: 6 months 
 
Based on data from initial exercise tests, activity questionnaires, and 
medical history the intervention group will get individual instructions with 
recommendations aimed to perform 150 min of physical activities per 
week Heart rates during exercise sessions will be monitored with the aim 
of physical activities at moderate-intensity. 
The exercise group is equipped with an activity monitor wearing at the 
hand of the non-dominant arm (Forerunner 35, Garmin, Germany). 
Participants will be asked to wear the monitor throughout the intervention 
Study Title: Effects of a physical activity intervention on metabolic syndrome severity in employees from the Volkswagen AG. 
Synopsis Version: 1.0 from 31.05.2017 
Principal Investigator: Prof. Dr. med. Uwe Tegtbur 
 
 
 
IRB Synopsis form non-AMG/non-MPG  2 / 4 V.1.2-20180323-1400 
period and be familiarized to use the device. Data will be recorded 
continuously when the activity monitor is attached. In addition preset or 
self-defined activities (e.g. cycling, cardio-training, walking outdoor and 
walking indoor) can be started and stopped. Additionally all participants 
will be asked to install a self-designed smartphone application “Rebirth 
active” (d.velop AG, Gescher, Germany) on their mobile phone to 
receive information about the study in general, individual training goals, 
recommended heart rates for endurance activities, tips for increased 
physical activity in everyday life, and supervisor contact details. Based 
on activity monitor data and personal communications participants 
receive feedback and adaptations for their further training schedule 
during the meetings with the exercise scientist once monthly. 
The supervising exercise scientist will search for fitting training facilities 
around the participant’s home and at the workplace (e.g. gyms, sport 
classes, rehabilitation courses) to help participants to increase physical 
activity in everyday life. 
8 Vulnerable Subjects 
(Check all that apply) 
[ ] children 
[ ] pregnant or lactating women 
[ ] individuals > 75 years of age 
[ ] patients in palliative care 
[ ] legally non-competent individuals due to acute illness 
[ ] legally non-competent individuals due to chronic disease 
[ ] imprisoned or otherwise legally detained individuals 
[ ] nursing home inhabitants 
9 Key Inclusion Criteria 
(Mandatory: age/sex) 
- women and men 
- ≥ 18 years 
- diagnosis of ≥ 3 of 5 criteria of the metabolic syndrome 
according to the AHA/NHBLI 
10 Key Exclusion Criteria - current participation in occupational health program 
- acute or chronic infections 
- oncological diseases 
- joint replacements or any surgery within the last 6 weeks 
- pregnant or breast feeding women 
- any condition that precludes realization of an exercise 
intervention. 
11 Key Procedures - exercise testing’s 
- venous blood sampling from an brachial vein 
- body composition 
- questionnaires 
12 Objective(s) The metabolic syndrome (MetS) is a clustering of different abnormalities, 
increasing the risk for the development of cardiovascular and metabolic 
diseases, and cardiovascular mortality. Beside the prognostic disease 
and mortality risk, the MetS has been shown to be related to more 
absent workdays due to illness, productivity loss, and higher health-care 
costs. The MetS is therefore not only a health-related but also a relevant 
socioeconomic issue, particularly in ageing societies in whom employees 
are expected to work at higher ages. Several studies have tested the 
impact of physical activity programs on anthropometric and metabolic 
parameters. However, data for the effectiveness of regular exercise on 
metabolic syndrome severity and associated changes in work ability are 
sparse. In addition, whether physical activity-induced improvements in 
health-related (mental and physical) outcomes are similarly associated 
with changes in ability to work depending on an employees work area is 
Study Title: Effects of a physical activity intervention on metabolic syndrome severity in employees from the Volkswagen AG. 
Synopsis Version: 1.0 from 31.05.2017 
Principal Investigator: Prof. Dr. med. Uwe Tegtbur 
 
 
 
IRB Synopsis form non-AMG/non-MPG  3 / 4 V.1.2-20180323-1400 
unclear. The evaluation of a population at risk covering different areas of 
work, (including shift work, blue- and white collar-work) will help to judge 
whether our personalized and telemonitoring-supported intervention 
might be feasible and effective to improve disease risk and indices of  
workplace productivity arising from metabolic syndrome conditions. 
Therefore, the aim of the study was to test the hypothesis that a 6-month 
lifestyle intervention, focusing on exercise training with individualized 
telemonitoring-based supervision, will result in improvements of MetS 
severity as well as work- and health-related outcomes among company 
employees. 
 
13 Outcome(s) 
(If not applicable: n.a.) 
primary endpoint:            metabolic syndrome severity as assessed  
                                                 with a metabolic-z-score (MetS-z-score) 
key secondary endpoint(s):      work ability 
                                                  exercise capacity 
                                                  health-related quality of life 
                                                  body composition 
                                                  adherence to the activity intervention 
assessment of safety:              any adverse or unexpected event was    
                                                  documented for any enrolled subject and  
                                                  descriptively analyzed 
14 
 
Statistical Analysis 
(If not applicable: n.a.) 
Efficacy/ Aim  
The primary aim of the study is to test whether a 6-month supervised 
and telemonitoring-supported physical activity intervention will result in 
improvement of metabolic syndrome severity in company employees. 
The study will have a randomized-controlled design with a waitlist-control 
group. 
Description of the primary endpoint accuracy analysis and population: 
For analysis of the primary outcome an Analysis of Covariance model 
(ANCOVA) will be used with the change of the MetS-z-score (6 months-
baseline) as response variable. Explanatory variables are gender, the 
MetS-z-score at baseline and the study group (intervention- vs. control). 
The intervention is successful, if the lower mark of the two-sided 95%- 
confidence interval is bigger than 0. 
To test for within-group differences from baseline to end of intervention a 
two-sided Students T-Test for paired samples will be applied. Univariate 
associations between parameters will be tested using Pearson’s 
correlation coefficient. The type-I-error is set to 5% (two-sided).   
For all outcomes the analysis will be carried out according to the 
intention-to-treat (ITT) principle, including all randomized subjects. 
Missing values at the end of the 6 months intervention will be 
conservatively replaced by the baseline observation carried forward 
method to avoid an overestimation of the effect through drop-outs 
Safety: 
Any adverse, serious adverse or unexpected event will be documented, 
descriptively analyzed, and compared between study groups 
Secondary endpoint(s): 
For secondary outcomes the same analysis method will be used as 
described for the primary outcome. For dichotomic endpoints a logistic 
regression will be used and adjusted for the same co-variables. 95%-
confidence interval will be calculated for all secondary endpoints. 
15 Sample Size to be assessed for eligibility: n = 400 
to be assigned to the trial: n = 312 
Study Title: Effects of a physical activity intervention on metabolic syndrome severity in employees from the Volkswagen AG. 
Synopsis Version: 1.0 from 31.05.2017 
Principal Investigator: Prof. Dr. med. Uwe Tegtbur 
 
 
 
IRB Synopsis form non-AMG/non-MPG  4 / 4 V.1.2-20180323-1400 
to be analysed:   n = 312 according to ITT 
case number at MHH:  n = 0 
16 Sample Size Justification The primary outcome of our study was the change of the MetS-z-score 
with a 6-month exercise intervention compared to controls. Sample size 
was calculated for the primary outcome on the basis of an earlier study 
which reported changes for a MetS-z-score by a similar intervention of -
0.6 [95%CI -0.7 to -0.5] (Jeejeebhoy K et al., CMAJ Open 2017. 
DOI:10.9778/cmajo.20160101). We calculated (MedCalc Statistical 
Software version 17.6, Ostend, Belgium) that 132 participants in each 
group would be necessary to observe a significant effect of the 
intervention on the MetS-z-score (90% power, alpha=0.05 two-sided). 
17 Trial Duration recruitment period (months):  6 months 
first participant in to last participant out (months): 18 months 
18 Discussion of Perceived / 
Expected Risks and 
Benefits 
Specific risks in this study include exercise testing and venous blood 
sampling. During exercise testing there is a theoretical risk of cardiac 
arrhythmia. Any blood sampling has a certain risk of infection. We expect 
benefits for cardiovascular, metabolic and mental health due to the 
intervention. Because we will perform exercise testimngs and blood 
samplings in as standardized fashion according to current guidelines we 
believe that the expected benefits will outweigh the risk of the 
intervention. 
19 Data Monitoring 
Committee 
[ ] yes [X] no 
20 Feasibility of Recruitment The recruiting of volunteers for the physical activity program will take 
place at the Volkswagen factory in Wolfsburg by internal informative 
events and internal advertisement. The number of employees in this 
factory is all in all about 70.000 employees. Due to the expectedly 
positive effects of the event and the degree of esteem of training to 
improve health and well-being, we are not expecting any problems 
referring to the recruitment. We expect that the planned 400 volunteers 
will be recruited. 
21 Participation Fee 
(Amount in EUR) 
Not intended 
22 Participating Centres Volkswagen factory in Wolfsburg (lower saxony) 
23 Funding/ Role and 
Responsibilities 
Funding: Audi BKK health insurance and the German Research 
Foundation through the cluster of excellence “REBIRTH” 
 
The funder of this study had no role in the study design, data collection, 
data analysis, data interpretation, writing of the report, or decision to 
submit for publication.  
24 Previous IRB 
Submission(s) 
First application 
 
 
 
 
 
 Hannover, 01.06.2017 
__________________________________  ____________________________ 
Name and Signature(s) of Principal Investigator(s)  Place, Date 


English

Protocol for study entitled: "Telemonitoring-supported exercise training, metabolic syndrome severity, and work ability in company employees: a randomized controlled trial."

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