Trial document




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  DRKS00025033

Trial Description

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Title

Individualized exercise promotion program for people with multiple manifested risk factors to increase physical exercise in the long term (MultiPill-Exercise)

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Trial Acronym

MultiPill-Exercise

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URL of the Trial

http://multipill.medizin.uni-tuebingen.de

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Brief Summary in Lay Language

Multimorbidity, the disease of at least two chronic conditions in a person, is an increasing burden on the healthcare system. More than 50% of adults over the age of 65 years suffer from multimorbidity and the number continues to increase with age. Multimorbidity is associated with a lower quality of life as well as social, physical, and psychological impairments. Currently, there are few conservative treatment options for multimorbidity. The effectiveness of sport and exercise in the therapy of various chronic diseases has already been proven, but not for patients with multiple chronic diseases.
International and national physical activity recommendations for adults with chronic diseases advise 150 minutes/week of moderate endurance activities or 75 minutes/week of intensive endurance activities or an equivalent combination, as well as muscle-strengthening exercises twice a week. In Germany, less than half of the population achieves these physical activity recommendations, and in the group of individuals with chronic diseases, even fewer are physically active according to the recommendations.
Therefore, in this study we would like to find out whether it is possible to engage persons with multiple chronic diseases in regular physical activity and whether physical activity has positive health effects.
For this purpose, courses from the health program of a statutory health insurance company will be compared with a newly designed program MultiPill-Exercise. The main focus is, of course, on whether the programs are feasible for the participants. In this context, we also investigate whether the health benefits and costs of the programs are in a responsible relationship to each other.
For the study, we are looking for individuals at increased risk or already beginning to experience multimorbidity. The study is addressed to persons with at least two increased risk factors or already suffering from at least two diagnosed chronic multiple diseases such as knee/hip osteoarthritis, diabetes mellitus type 2, obesity and/or cardiovascular diseases. In order to participate in the study, participants should have already been insured with the AOK-Baden-Württemberg in the last two years. In addition, it is important that a constant medication was available in the last three months with regard to the above-mentioned diseases.

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Brief Summary in Scientific Language

Multimorbidity, defined as the presence of at least two concurrent chronic conditions in an individual (Moffat et al., 2015), is a major problem for healthcare systems in industrialized nations. Multimorbidity is often associated with medical complications and reduced quality of life. Mental, physical, and social limitations are common problems (Struckmann, 2014 et al. & Puth 2017 et al.).

Currently, the most common conservative treatment option for multimorbidity is pharmacologic therapy. Although evidence for the efficacy of physical activity in the prevention and treatment of individual non-communicable chronic diseases is available, physical activity is not postponed as a form of therapy in everyday care (Löllgen, 2013). National and international physical activity recommendations for chronic diseases are available (Pfeifer et al., 2016 & Hämäläinen et al., 2020). However, less than half of German adults do not reach these recommendations and individuals with chronic multiple diseases are even less physically active (Sudeck et al., 2021). In addition to physical activity, diet is another important component of therapy for noncommunicable chronic diseases with an inflammatory component (Esser et al., 2014).
A systematic training that includes physical activity promotion strategies and behavior change techniques is necessary to engage inactive individuals in a long-term health-promoting lifestyle (Sudeck et al., 2016).

This study is designed as a multi-site individually randomized controlled superiority pragmatic trial with two parallel groups. The study will compare two groups (n=126 each). Subjects in the control group choose courses from the statutory health insurance program, while the intervention group receives a comprehensive exercise and lifestyle intervention (MultiPill-Exercise). For this purpose, the subjects are randomized in a 1:1 ratio. Allowing for a 25% drop-out rate, a total of 360 subjects will be enrolled in the study.

The primary objective of this study is to investigate whether MultiPill-Exercise can help people with chronic multiple diseases to be regularly active in sports after a six-month intervention and a follow-up period of 12 months.
Secondary evaluations will assess program effectiveness on general and disease-specific parameters, health economic parameters, sport and health psychological parameters, and program adherence and safety. Further process evaluations will examine the implementation of the Multipill Exercise intervention in regular health care settings.

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

Yes

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Description IPD sharing plan:

A study protocol will be published. Results will be published after the end of the trial.
The datasets generated and/or analyzed during the current study are not publicly available due to the data protection policy from the cooperating insurance fund but are available from the corresponding author on reasonable request (in anonymized form).

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Organizational Data

  •   DRKS00025033
  •   2021/09/30
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  •   no
  •   Approved
  •   628/2021BO2, 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

  •   Diabetes mellitus type 2, cardio-vascular diseases, knee and/or hip osteoarthritis, overweight/obesity
  •   Depression, osteoporosis, chronic low back pain
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Interventions/Observational Groups

  •   Intervention MultiPill-Exercise: Participants receive an intervention over 24 weeks. The intervention is based on the International Classification of Functioning, Disability and Health (ICF). Special consideration is given to personal and structural contextual factors of the participants. Individual sport-related motives as well as person-related support factors are included to individualize the program. In addition to a systematic physical activity program based on international and national physical activity recommendations, the program also addresses nutrition.
    The intervention can be divided into three overarching components: (1) exercise, 2x12 weeks with decreasing supervision, (2) patient education focusing on knowledge transfer, and (3) the application of further behavior change techniques.

    Participants will also receive lectures on topics related to exercise theory, motivation and volition, and nutrition theory during the first 12 weeks, in addition to guided exercise that will take place individually or in a group setting, indoor or outdoor. Five individual counseling sessions are also integrated. During the second 12 weeks, participants are expected to continue the exercise activity mostly independently with the same duration and intensity. The educational elements in this phase booster the maintenance of exercise and the topic nutrition.
  •   Participants of the control group (CG) will receive health offers of the range of the statutory health insurance company. They can attend several programs. Potential offers are in the field of nutrition (nutrition workshops), exercise and relaxation (walking, gymnastics, strength-endurance training), special DMPs (coronary heart disease, diabetes mellitus), general health offers (hip-knee program) and fit and active (walking, functional fitness, outdoor fitness, back fit). A focus of the general health offers is to reduce physical inactivity and to strengthen physical health resources. The exercise programs last 8-12 weeks. Participants of the CG will be provided with options by an exercise specialist of the insurance company and will then be able to enroll in the selected programs. The combination, number and choice of programs can, for the most part (except for offers according to § 20 SGB V), be freely arranged according to the participants' own preferences. All programs will be provided by exercise specialists of the statutory health insurance company and are based on their own curricula, which are adhered to in a restrictive manner.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   0
  •   N/A
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Primary Outcome

Physical Activity Status, evaluated with the self-reported EHIS-PAQ (HEPA-Index) 6, hierarchichal after 18 months after baseline.

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Secondary Outcome

Activity Status (EHIS-PAQ: Muscle Strength, Accelerometry), General Health-Related Quality of Life (Veterans Rand-12), Disease-Specific Measures (HOOS, KOOS, Diabetes Risk Test, PROCAM score, VAS), Performance Measures (Spiroergometry, Resting and Exercise ECG, 30-Second Sit-Stand Test, BIA, Fasting Blood Collection and Capillary Blood Collection on Guthrie Cards), Sport and Health Psychology Measures (Self-Efficacy Expectancy, Self-Concordance, exercise-related health competence, exercise-related motivational competence, ability to plan and act, affective attitude toward exercise, motives and goals of exercise, exercise anxiety), economic data (nonspecific and specific illness-related costs and days of illness, intervention costs), process evaluation (satisfaction with the intervention and trainers, feasibility), attendance and safety (training diaries and attendance lists).
Questionnaires will be conducted at baseline and after 3, 6, 12, 18 months. Physical performance measures will be hold at baseline and after 6 and 18 months.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2022/04/19
  •   320
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

AOK insured (at least 2 years in advance), constant medication for at least 3 months, at least 2 of 4 risk factors or manifested diseases: Diabetes mellitus type 2 (diabetes risk test > 57 points), cardiovascular disease (PROCAM > 10-year risk of heart attack 10%, hip and/or knee osteoarthritis (diagnosed by a physician in advance), overweight/obesity (BMI > 27 kg/m²).

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Exclusion Criteria

End-organ damage, appointment for selective joint replacement, exercise activity before start of intervention > 75 % of the nationale physical activity recommendations, personal possible exercise time < 20 minutes at a time.

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Addresses

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    • AOK Baden-Württemberg
    • Presselstraße 19
    • 70191  Stuttgart
    • Germany
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    • Universitätsklinikum Tübingen, Institut für klinische Epidemiologie und angewandte Biometrie
    • Mr.  Prof. Dr.  Peter  Martus 
    • Silcherstraße 5
    • 72076  Tübingen
    • Germany
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    • Eberhard Karls Universität Tübingen, Institut für Sportwissenschaft
    • Mr.  Prof. Dr.  Gorden  Sudeck 
    • Wächterstraße 67
    • 72074  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen, Medizinische Klinik, Abteilung Sportmedizin
    • Ms.  Prof. Dr.  Inga  Krauß 
    • Hoppe-Seyler Str. 6
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen, Medizinische Klinik, Abteilung Sportmedizin
    • Ms.  M.A.  Simone  Schweda 
    • Hoppe-Seyler Str. 6
    • 72076  Tübingen
    • Germany
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    • AOK Baden-Württemberg Unternehmensbereich Kunde & Gesundheit
    • Mr.  PD. Dr.  Gerhard  Müller 
    • Presselstraße 19
    • 70191  Stuttgart
    • 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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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.