title: Study protocol for prevention of falls: a randomized controlled trial of effects of vitamin D and exercise on falls prevention.
abstract: BACKGROUND
  Falls are the leading cause of unintentional injury and injury-related death among older people. In addition to physical activity, vitamin D also may affect balance and neuromuscular function. Low serum 25-hydroksivitamin D level increases the risk of bone loss, falls and fractures. Thus, an appropriate exercise program and sufficient vitamin D intake may significantly improve not only functional balance, but also balance confidence. Balance represents a complex motor skill determined by reaction time, muscle strength, and speed and coordination of movement.
  
  
  METHODS
  A 2-year randomized double-blind placebo-controlled vitamin D and open exercise trial of 409 home-dwelling women 70 to 80 years of age comprising four study arms: 1) exercise + vitamin D (800 IU/d), 2) exercise + placebo, 3) no exercise + vitamin D (800 IU/d), 4) no exercise + placebo. In addition to monthly fall diaries, general health status, life style, bone health, physical functioning, and vitamin D metabolism will be assessed. The primary outcomes are the rate of falls and fall-related injuries. Secondary outcomes include changes in neuromuscular functioning (e.g. body balance, muscle strength), ADL- and mobility functions, bone density and structure, cardiovascular risk factors, quality of life and fear of falling.
  
  
  CONCLUSIONS
  The successful completion of this trial will provide evidence on the effectiveness of exercise and vitamin D for falls reduction.
  
  
  BACKGROUND
  ClinicalTrial.gov -register (NCT00986466).
authors.affiliation: The UKK Institute for Health Promotion Research, PO Box 30, FI-33501 Tampere, Finland. kirsti.uusi-rasi@uta.fi
authors.forename: Kirsti
authors.initials: K
authors.lastname: Uusi-Rasi
authors.forename: Pekka
authors.initials: P
authors.lastname: Kannus
authors.forename: Saija
authors.initials: S
authors.lastname: Karinkanta
authors.forename: Matti
authors.initials: M
authors.lastname: Pasanen
authors.forename: Radhika
authors.initials: R
authors.lastname: Patil
authors.forename: Christel
authors.initials: C
authors.lastname: Lamberg-Allardt
authors.forename: Harri
authors.initials: H
authors.lastname: Sievänen
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control*; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D015444:Exercise / Q000502:physiology*; D005081:Exercise Therapy / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D009043:Motor Activity / Q000502:physiology; D012307:Risk Factors; D016896:Treatment Outcome; D014807:Vitamin D / Q000627:therapeutic use*
chemical_list: D014807:Vitamin D