Trial document





This trial has been registered retrospectively.
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  DRKS00013262

Trial Description

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Title

Evaluation of analysis for validation of efficiency of practical exercise modalities in elderly men at risk for osteoporosis

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Trial Acronym

[---]*

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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

Systematic evaluation of changes of different diagnostic parameters for physical performance ability, fracture risk and ability to pursue activities of daily living after 6 months of exercise intervention via different age and disease specific methods

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Organizational Data

  •   DRKS00013262
  •   2018/01/15
  •   [---]*
  •   yes
  •   Approved
  •   111/14, Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
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Secondary IDs

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

  •   M81.9 -  Osteoporosis, unspecified
  •   M62.80 -  [generalization M62.8: Other specified disorders of muscle]
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Interventions/Observational Groups

  •   Conventional resistance training, 2x/week, 20-30min, for 6 months
  •   Qi Gong 2x/week group class, 30-40min, for 6 months
  •   Whole Body Vibration 2x/week, 20min, for 6 months
  •   Spinal Orthosis, daily wearing recommended over 6 months
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Isometric trunc muscle strength measured by dynamography at baseline and after 6 months of exercise
(exploratory endpoint; no confirmatory approach)

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Secondary Outcome

Changes in the following parameters

• Short Physikal Performance Battery • Grip Strength (Handheld-Dynamometry)
before as well as 3 and 6 months after initiation of exericse intervention, respectively

• Body Sway (Balance X) • Jumping mechanography (Leonardo) • Bioimpedance Analysis (Akern) • Gait Analyiss (GAITRite) • Body composition (DXA, Bone mineral density, Bone mass, Fat mass, Fat-free body mass) • Muscel volume and constitution, paravertebral muscels lumbar spine (MRT) • Spirometry
before and 6 months after initiation of exericse intervention, respectively

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/05/05
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   65   Years
  •   no maximum age
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Additional Inclusion Criteria

Men aged ≥ 65 years with at least one of the following critieria indicating osteoporosis

• reduced Bone Mineral Density (DXA) T-Score < - 2,5 (Hip or Lumbar Spine)
• previsously confirmed diagnosis of osteoporosis
• ongoing specific treatment of for osteoporosis
• anticipated 10-year fracture-risk >20% according to current DVO-Guidelines

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Exclusion Criteria

• Presence of Total Hip / Knee / Ankle joint replacement
• Pacemaker / AICD
• Diagnosis of epilepsy
• acute thrombosis (<3 months)
• acute vertebral disc herniation (<3 months)
• Rheumatoid Arthritis
• gallstones
• stone anywhere in the urinary tract
• Open hernias
• Surgery within the last 3 months
• acute head injury
• current infection
• current fractures (< 3 months )
• any condition that would put the participant at an unacceptably high risik in case of participation

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinische Studieneinheit, Orthopädische Klinik, Universität Würzburg
    • Mr.  Dr. med.  Lothar  Seefried 
    • Brettreichstraße 11
    • D-97074  Würzburg
    • Germany
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    • Klinische Studieneinheit, Orthopädische Klinik, Universität Würzburg
    • Mr.  Dr. med.  Lothar  Seefried 
    • Brettreichstraße 11
    • D-97074  Würzburg
    • Germany
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    • König-Ludwig-Haus
    • Ms.  Silke  Achtziger 
    • Brettreichstraße 11
    • 97074  Würzburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinische Studieneinheit, Orthopädische Klinik, Universität Würzburg
    • Mr.  Dr. med.  Lothar  Seefried 
    • Brettreichstraße 11
    • D-97074  Würzburg
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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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.