Trial document




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  DRKS00016702

Trial Description

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Title

Promotion of physical activity for vulnerable persons with regard to chronic inflammatory diseases: Conceptualisation, implementation and evaluation of a range of activities at the interface of the life worlds of health care, sport and leisure.

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Trial Acronym

MultiPill Exercise

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URL of the Trial

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Brief Summary in Lay Language

Multimorbidity is a major problem in Europe. The number of people with chronic conditions is increasing rapidly. Consequential the demand for prevention and rehabilitation programs rises. Until now, national policies and strategies focusing on patients with multiple chronic conditions have not been developed. The enormous benefits of physical exercise for multiple diseases have been proven, but so far most of the interventions focus on specific diagnosis other than the combinations of multiple chronic diseases. The benefit of physical activity programs on multiple diseases and the implementation of such an intervention in the living environments is still an open research question. Therefore it will be evaluated in this trail.

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Brief Summary in Scientific Language

Physical inactivity is one of the major risk factors for many diseases and early mortality. Despite the knowledge about the efficacy of physical activity, which has been proven in numerous cohort studies for more than 30 years, this form of therapy has not yet received enough practical application. The most common chronic diseases in industrial nations are cardio-vascular diseases, diabetes mellitus type 2, overweight and musculo-skeletal diseases. All these symptoms are based on a common risk factor: chronic inflammation. The aim of this study is to develop a program that is equally effective for these diseases. The intervention is based on the national movement recommendations for adults. In addition to promoting physical-sport activity, theoretical aspects of training, nutrition and behavioural change will also be taught. In order to increase the motivation for physical-sport activity, the identification of barriers and motives is also part of the intervention. The establishment of multiplicators or caretakers with the task of transferring them to local sports facilities should also contribute to a long-term commitment to sport.
In addition, selected laboratory parameters will be collected to demonstrate the molecular biological effectiveness of physical activity with regard to inflammation, metabolism and cartilage metabolism. During the entire duration of the study, the adherence/compliance of the target group, the feasibility of the intervention as well as the functionality of the multipliers (doctors, health professionals, associations,...) will be continuously evaluated.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00016702
  •   2019/07/19
  •   [---]*
  •   yes
  •   Approved
  •   298/2019BO2, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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Health Condition or Problem studied

  •   Multimorbidity with risk factors or already manifested disease for 2 of the following four diseases: diabetes mellitus type 2, cardio-vascular diseases, hip and knee arthrosis, overweight/obesity
  •   M15-M19 -  Arthrosis
  •   E66 -  Obesity
  •   E10-E14 -  Diabetes mellitus
  •   I10-I15 -  Hypertensive diseases
  •   I20-I25 -  Ischaemic heart diseases
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Interventions/Observational Groups

  •   The intervention includes, among other things, a detailed medical examination including a capacity diagnosis to determine individual fitness. Based on the results, the participants receive a 12-week mostly supervised and individually tailored exercise program. In addition, the intervention includes theoretical training contents and personal consultations to improve the participants' background knowledge on training, nutrition and behavioral techniques as well as active everyday life. Following the basic program, the participants are encouraged to maintain physical activity to the same extent either independently or in the club.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   II
  •   N/A
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Primary Outcome

t1: 12 weeks after the start of the intervention: Effectiveness of the intervention on health benefits/ disease specific measures:
cardiovascular: Procam-Score, spiroergometry;
metabolic: blood lipid values, changes in weight, abdominal fat mass, oral glucose tolerance, inflammatroy mediators (CRP, IL6, cytokines); Muskolo-skeletal: WOMAC, isometric maximal force

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Secondary Outcome

t2: 24 weeks after the start of the intervention: Disease related measurements: physical activity (Quantity of the type of activity and quality, e.g.: intensity), affective response to physical activity, health realted quality of life (VR-12), sport specific and general self-efficacy (SES questionaire), motives for sport participation (BMZI), activity of daily living

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/09/01
  •   34
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Arthritis: diagnosed arthritis of the hip or knee accordingto the clinical ACR- criteria, WOMAC > 15 in pain and function;

diabetes: German diabetes risk-test (DRT) ≥57 points, HbA1c < 6,5%, fasting plasma glucose <126 mg/dl;

cardio-vascular: PROCAM-Score > 1,2 of the age-approriate reference; obesity/adipostity: BMI ≥ 27 und ≤ 35

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Exclusion Criteria

end-organ damage, appointment for elective joint replacement, BMI ≥ 35, physical activity before the intevention meets more than 75% of the activity recommendations for adults

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Addresses

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    • Universtiätsklinikum Tübingen, Abteilung Sportmedizin
    • Hoppe-Seyler-Str. 6
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen, Abteilung Sportmedizin
    • Ms.  Prof. Dr.  Inga  Krauß 
    • Hoppe-Seyler Str. 6
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen, Abteilung Sportmedizin
    • Ms.  Simone  Schweda 
    • Hoppe-Seyler Str. 6
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • AOK Baden-Württemberg
    • Presselstraße 19
    • 70191  Stuttgart
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
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  •   2020/07/24
  •   39
  •   39
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* This entry means the parameter is not applicable or has not been set.