RANDOMIZED CONTROLLED TRIAL TO REDUCE FALLS AND FEAR OF FALLING IN FRAIL ELDERLY

Approximately 750.000 Dutch elderly people fall at least once a year, which
often results in physical injuries and fear of falling, with high costs and
far-reaching consequences on functionality, physical activity, quality of life
and mental wellbeing. Falling is not only a burden for patients, it also is a
burden for their caregivers, with frustration, distress and mood disorders as a
possible result for both. Dementia or milder cognitive impairment, fear of
falling, difficulties in performing dual tasks while walking, and disorders in
gait and balance determine the complexity of the problem of recurrent falling
in the growing group of frail elderly people, because they all result in an
increased risk of falling. However, the pathophysiological background of falls,
gait problems and dementia is largely unknown. The general pathophysiological
hallmark of aging is lability in homeostatic mechanisms of organs (the
inability to generate stable organ output). This lability results in an
impaired ability to adapt to stress and in increased biological variation in
outcome measures within individuals. In this study we aim at developing an
intervention to reduce recurrent falling in frail elderly fallers and their
fear of falling because so far no secondary prevention study proved efficacy in
this high-risk patients.

-To test the efficacy and determine the costs of a multifaceted intervention
program to reduce falls incidence rate and fear of falling, and thereby improve
mental wellbeing in community dwelling frail elders, with high level of
comorbidity and cognitive impairment, who fell at least once in the past 6
months and consulted an outpatient geriatric clinic.
-To train and support the informal caregivers, which we consider as absolute
precondition for an effective intervention in this group, and to improve their
feeling of competency in taking care of these patients.
-To test, as secondary outcomes, whether this intervention reduces fall related
injuries, improves physical activity, functional performance measures, and
biomarkers for vascular health/endothelial function and frailty.
- To test wether a high short term intraindividual biological variability in
gait and cognition
variables predicts a higher chance of falling, worse gait performance and
cognitive decline in
older people after long term follow up.

randomized controlled, single-blind trial

A multifaceted fall prevention program for frail elders to reduce fear of
falling and fall incidence rate, consisting of physical and cognitive
components. Moreover, it includes a trainings program for caregivers to learn
to provide supervision and advice the patients.

The outcome of this study may have important reflections on protocols to
prevent falling and reduce fear of falling among elders and on health care
decision makers to stimulate starting new fall clinics and implement these
protocols. Through this study the wellbeing and functionality of frail elders
and their caregivers could be improved. As falling has an enormous economic
burden, a new effective fall prevention intervention could reduce health care
costs substantially. The tests consisting of questionnaires, and gait and
balance measurement are non-invasive and safe. Taking blood samples is an
invasive procedure, although no serious adverse effects will be expected. There
are no foreseeable risks associated with the participation in this study.
However, a burden will be placed on participating individuals because the
training sessions and measurements are time-consuming.