Trial document





This trial has been registered retrospectively.
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  DRKS00009890

Trial Description

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Title

Standardized training for improvement of the musculoskeletal unit and for prevention of falls and fracture in the elderly: a prospective randomized controlled trial.
Age adjusted impact strength and enDurance training in Osteoporotic patients - Novel structu-red Intervention in Seniors (the Rostocker ADONIS-Trial)

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Trial Acronym

ADONIS

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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-related deteriorations of the musculoskeletal unit and a concomitant decline of physical capabilities directly translate into an increased risk of falls and fractures. Life-long physical acitivity has been identified as an important measure to preserve muscle strength and bone quality and thus to maintain bipedal locomotion and postural control even in older age. However, training programms directed to improve neuromuscular and musculosceletal function of the legs are scarce with respect to older osteoporotic patients. Therefore, we conducted a pilot-study to investigate the effects of a modified step aerobics training on maximum voluntary contraction strength and neural activation of the plantar flexors as well as bone metabolism in this particular group of patients.

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Organizational Data

  •   DRKS00009890
  •   2016/01/22
  •   [---]*
  •   yes
  •   Approved
  •   A2012-0099, Ethik-Kommission an der Medizinischen Fakultät der Universität Rostock
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   M80-M85 -  Disorders of bone density and structure
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Interventions/Observational Groups

  •   training of strength and endurance (step aerobics) two times a week, 45 min per session
    medication as prescribed
  •   no intervention
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Other
  •   Parallel
  •   I
  •   N/A
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Primary Outcome

feasibility of the training
acceptance of intensity and frequence
Questionaires (QUALEFFO-41, FES-1) at time of enrollment (baseline) and after 3 and 6 months of training

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Secondary Outcome

improvement of muscular function (power) by 10% within 6 months of training
Questionaires, assessment of endurance and power at time of enrollment (baseline) and after 3 and 6 months of training

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2012/10/15
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

age ≥ 65 years, T-score ≤ - 2.5 standard deviation at the lumbar spine and/or femoral neck (measurement of BMD at max. 36 months prior to enrolment) or a history of osteoporotic fractures, walking speed ≥ 0.8 m·s-1, chair rising test ≤ 10 s, body mass index ≥ 20 kg/m2, increased risk of falls and fractures, i.e. at time of enrolment at least one fall during the last 12 months.

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Exclusion Criteria

active participation in a strength and/or endurance training during a 24-months period prior to enrolment, sports activity ≥ two times a week, cardiac insufficiency, cardiac pacemaker, chronic renal failure, non-curative treated tumours, systemic application of corticosteroids, peripheral arterial occlusive disease, poor mobility, i.e. walking more than 5 min not possible, osteoarthritis, rheumatism and/or severely impaired balance, planed absence of more than two weeks during the study period

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Unfall-, Hand-, und Wiederherstellungschirurgie
    • Mr.  Prof. Dr. med.  Thomas  Mittlmeier 
    • Schillingallee 35
    • 18057  Rostock
    • Germany
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    • Klinik für Unfall-, Hand-, und Wiederherstellungschirurgie
    • Mr.  Prof. Dr. med.  Thomas  Mittlmeier 
    • Schillingallee 35
    • 18057  Rostock
    • Germany
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    • Klinik für Unfall-, Hand-, und Wiederherstellungschirurgie
    • Mr.  Prof. Dr. med.  Thomas  Mittlmeier 
    • Schillingallee 35
    • 18057  Rostock
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Unfall-, Hand-, und Wiederherstellungschirurgie
    • Mr.  Prof. Dr. med.  Thomas  Mittlmeier 
    • Schillingallee 35
    • 18057  Rostock
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/07/31
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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.