Exercise Intervention to Prevent Fall-related Fractures and Other Injuries : The Ossébo Study
Condition: Accidental Falls; Fractures; Fall-related Injuries
MeSH terms: Wounds and Injuries; Fractures, Bone
Study type: Interventional

Summary: 
      1. Primary objective: to evaluate the effectiveness of a fall prevention exercise program
           in preventing falls resulting in fractures and other physical traumas.

        2. Secondary objectives:

             -  to better understand the mechanisms by which physical exercise prevents falls and
                ensuing injuries (improvement in physical functional abilities, global physical
                activity level, general physical and psychological wellbeing and self-confidence).

             -  to determine the individual factors associated with long-term adherence to the
                exercise program.
    

Detailed description: 
      Background : Osteoporotic fractures are a major cause of morbidity and disability in elderly
      women. Most of these fractures result from a fall. Falls prevention measures largely
      applicable in the population may contribute to significantly reduce the number of fractures
      in the population. Recent randomized controlled trials have shown that exercise programs of
      relatively low intensity, but centered on balance retraining and targeted to subjects at
      moderate risk, can reduce the risk of falls by 30% in community-dwelling elderly people
      (Province MA et al 1995 ; Gillepsie LD et al 2003 ; Chang JT et al 2004). But, the
      effectiveness of exercise in preventing injuries caused by falls, in particular the most
      serious ones such as those accompanied by fractures, has not been demonstrated. Most previous
      trials are underpowered to examine the effect of fall prevention exercise programmes on
      severe injurious falls. Furthermore, there is no consensus about the outcomes of fall related
      injuries that should be evaluated in controlled trials, and the injurious falls definitions
      vary substantially across studies. Besides falls leading to fractures and other serious
      injuries, falls leading to medical care use ought to be considered as well, since their cost
      for society is high and their burden on the health care system heavy. Falls causing minor
      injuries are also important, as they may also have serious consequences, such as depression,
      fear of falling, and activity restriction.

      Objectives : To evaluate the effectiveness of exercise in preventing falls resulting in
      fractures or other physical traumas. Also, to better understand the mechanisms by which
      physical exercise prevents injurious falls (e.g., improvement in physical functional
      abilities, global physical activity level, general physical and mental health, and
      self-confidence), and to determine the individual factors associated with a good long-term
      adherence to the program.

      Method : Randomized controlled trial. Participants will be women aged 75 to 85 years old,
      living at home, but with impaired physical functional capacity (as assessed by simple
      functional tests). Women will be recruited using general population lists, such as
      voter-registration or supplemental health-insurance membership rolls. They will be randomized
      in 2 groups : one that will receive the intervention, and a control group without it. Each
      group will include 1000 women followed for 2 years, which will allow to demonstrate a 30%
      reduction in the frequency of serious falls in the intervention group (if the incidence of
      serious falls is around 8% per year). Falls and injuries occurrence will be monitored by
      asking women to return monthly calendar cards where they can mark the date of any falls. A
      telephone interview will then be realized in case a fall is reported to record the
      circumstances and consequences of the fall.

      Intervention : The intervention will last 2 years and will be implemented in partnership with
      the association SIEL (Sport, Initiatives, et Loisir) Bleu in 20 study centers located in
      large and medium-sized cities. It will include weekly exercise sessions in small groups, led
      by a qualified and specially trained instructor, and supplemented by simple exercises to do
      at home. The exercise program will focus on progressive balance retraining but will also
      include strength/resistance, coordination and flexibility training exercises.

      Evaluation criteria : The main outcome measure will be the incidence of serious falls defined
      as " an unexpected event in which the participant comes to rest on the ground, floor, or
      lower level " and accompanied by a fracture or another serious injury (including head
      injuries requiring hospitalization, joint dislocations, severe sprains, other non-specified
      serious joint injuries, and lacerations requiring suturing) (Buchner DM et al 1993). The
      effectiveness of the intervention on all injurious falls including those leading to more
      moderate injuries (such as bruises, cuts, abrasions or reduction in physical function for at
      least 3 days, or if the participant sought medical help (Campbell AJ et al 1997) will also be
      assessed. Falls associated with an intrinsic major event or an overwhelming hazard (e.g.,
      traffic accident) will be excluded. Intermediate outcome measures, which may help to explain
      the effect (or absence of effect) of the intervention, will be changes in physical functional
      capacity (e.g., balance, gait), global physical activity level, feeling of self-efficacy
      (fear of falling), and general physical and psychological well-being (quality of life). These
      changes will be evaluated on a sample of participants (160 per group) that will be
      re-examined at 1 year and 2 years.

      Expected results : The group intervention that we propose to assess is relatively simple to
      implement. It relies on a network of physical exercise instructors already established across
      France. In case of a demonstrated benefit it could therefore be easily generalized as part of
      a population-based public health program of fall-related injuries prevention in the elderly.
      The intervention should enable elderly women to preserve two elements essential to their
      quality of life as they age, that is, their functional capacity and their independence.
    

Intervention name(s): Fall prevention exercise program
Intervention type(s): Other
Intervention description(s): Weekly physical exercise sessions in small groups, led by a qualified and specially trained instructor, and supplemented by simple exercises to do at home.
The exercise program will focus on progressive balance retraining but will also include strength/resistance, coordination and flexibility training exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Prevention; Falls, accidental falls; Fractures; Physical injuries; Women; Elderly; Physical exercise; Balance exercise