Trial document




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  DRKS00011873

Trial Description

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Title

Sarcopenia in rheumatoid Arthritis

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Trial Acronym

SarkoRA

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The age-associated decline of muscle function (sarcopenia) is characterized by a loss of muscle mass, muscle force and muscle power and it is accompanied by an infiltration of fat in the muscle. This process is associated with limitations in the activities of daily living (ADL), falls and loss of autonomy. Due to chronic inflammation and limitations in mobility and physical functioning, patients with rheumatoid arthritis (RA) are affected by a decline in muscle function which is accompanied by an accumulation of visceral fat.
Prevalence of sarcopenia using different clinical definitions in patients with RA will be assessed. Additionally, a comparison between patients with RA and sarcopenia, patients with RA without sarcopenia and healthy controls regarding muscle mass and function, physical activity as well as different health parameter will be performed.
In total 289 patients with RA will be included in the study. Medical history, blood parameter, body composition including muscle mass (DXA), muscle density (pQCT), neuromuscular assessment of muscle force, muscle power and balance as well as several standardized questionnaires regarding activity of daily live, quality of life and physical activity will be performed.
The study will help to increase the knowledge about the complex phenomenon of sarcopenia in relation to rheumatoid cachexia. Risk factors should be identified to help developing new concepts for diagnosis and prevention of sarcopenia in patients with RA.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00011873
  •   2017/03/16
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  •   yes
  •   Approved
  •   EA4/155/16, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   M05 -  Seropositive rheumatoid arthritis
  •   M06 -  Other rheumatoid arthritis
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Interventions/Observational Groups

  •   Patients with rheumatoid arthritis (with and without sarcopenia) will be measured in a single visit:
    Muscle mass with dual-X-ray absorptiometry;
    muscle size and muscle density at the tibia with peripheral quantitative computed tomography;
    neuromuscular assessment of muscle force, muscle power and balance on a force plate system; grip strength; serum parameters; standardised questionnaires: health assessment questionnaire, quality of life SF-36, self reported balance (ABC scale), physical acivity (IPAQ_short); fatigue questionnaire (Bristol RA Fatigue - numerical rating scales BRAF-NRS);
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The aim of the study is to determine the prevalence of sarcopenia in rheumatoid arthritis using different definitions of sarcopenia (European Working Group on Sarcopenia in Older People EWGSOP, National Institutes of Health FNIH, ESPEN Consensus Statement)

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Secondary Outcome

Additional aims are:
Comparison of RA patients with and without sarcopenia concerning muscle parameters, physical activity, quality of life and blood parameter.
Association between sarcopenia in RA and influencing factors such as disease activity and duration, therapy with glucocorticoids, physical activity or sun light exposition.
Differences in muscle mass, muscle function, physical activity and blood parameters between RA patients and healthy controls.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/10/18
  •   289
  •   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

Diagnosis of RA (2/3 of the subjects with low disease activity based on the Disease Activity Score (DAS-28) ≤3.2; Ambulant (also with walking aid). Written informed consent.

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Exclusion Criteria

Any injury in the last 3 months affecting the musculoskeletal system. Any acute disease or worsening of a chronic condition affecting the musculoskeletal system. Participation in another clinical study. Pregnancy.

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Addresses

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    • Zentrum für Muskel- und Knochenforschung, Charité Campus Benjamin Franklin,
    • Ms.  Dr.  Gabriele   Armbrecht 
    • Hindenburgdamm 30
    • 12200  Berlin
    • Germany
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    • Charité Centrum Innere Medizin und Dermatologie; Medizinische Klinik mit Schwerpunkt Rheumatologie u. Klinische Immunologie
    • Mr.  Prof. Dr.  Frank  Buttgereit 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Zentrum für Muskel- und Knochenforschung; Charité - Campus Benjamin Franklin
    • Ms.  Dr.  Gabriele  Armbrecht 
    • Hindenburgdamm 30
    • 12200  Berlin
    • Germany
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    • Zentrum für Muskel- und Knochenforschung; Charité- Campus Benjamin Franklin
    • Ms.  Dr.  Roswitha  Dietzel 
    • Hindenburgdamm 30
    • 12200  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Rheuma-Liga Bundesverband e.V.
    • Maximilianstr. 14
    • 53111  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/05/06
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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.