Accidental Falls Clinical Trial
Official title:
Randomized Controlled Trial of Prevention of Fall-related Fractures and Other Injuries by Physical Exercise Among Community Dwelling Elderly Women
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
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