Trial to Reduce Falls Incidence Rate in Frail Elderly (CP)
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|ClinicalTrials.gov Identifier: NCT00512655|
Recruitment Status : Terminated (Extremely difficult recruitment. Preliminary analysis showed no effect of the intervention.)
First Posted : August 8, 2007
Last Update Posted : July 7, 2010
Background: Approximately 750,000 elderly Dutch people fall at least once a year, which often results in physical injuries and a fear of falling, with high costs and far-reaching consequences on functionality, physical activity, quality of life and mental well-being. Falling is not only a burden for patients, it is also a burden for their caregivers. Recurrent falling is a complex problem. However, the pathophysiological background of falls, gait problems and dementia is largely unknown. The general pathophysiological hallmark of aging is a liability in homeostatic mechanisms of organs. This liability results in an impaired ability to adapt to stress and in increased biological variation in outcome measures within individuals. In this study the investigators aim at developing an intervention to reduce recurrent falling in frail elderly fallers.
Hypotheses: The investigators hypothesize that the intervention program will decrease the number of falls and fear of falling and increase mental well-being, physical activity and functional performance in frail elderly people with a history of recurrent falling. In addition, the burden on the caregivers will be reduced due to the intervention and will be cost-effective. Furthermore, the investigators hypothesize that patients with a high short-term intra-individual biological variability in gait and cognition variables have a higher risk of falling, worse gait performance and cognitive decline after long term follow-up.
Study Design: Randomized, controlled, single-blind trial.
Study Population: 160 patients referred to a geriatric outpatient clinic, who fell at least once in the last 6 months and their primary caregivers (N=160).
Intervention: A multifaceted fall prevention program for frail elders to reduce falls incidence rate, consisting of physical and cognitive components. Moreover, it includes a training program for caregivers in which they learn to support and give advice to the patients, aiming to decrease the burden on the caregivers.
Primary Outcome Measures: The fall incidence rate is the primary outcome measure. Total observation time of falls will be 6 months after the start of the intervention.
Secondary Outcome Measures: In the patients, the secondary outcome measures are fear of falling (FES), quality of life (MOS-20), depression and general anxiety, functional performance in activities of daily living, physical activity, mobility, gait parameters, body sway and biomarkers of endothelial function and frailty. For the caregiver, the secondary outcome measures are caregiver's burden, mood and quality of life. In addition, intraindividual variability of cognition, balance and gait in both patients and caregivers, will be assessed and cost-effectiveness of the intervention will also be determined.
|Condition or disease||Intervention/treatment||Phase|
|Accidental Falls||Behavioral: Fall prevention course||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial to Reduce Falls Incidence Rate in Frail Elderly|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
Intervention: 5 week training program, 2 sessions per week (total of 10 sessions). Training includes both the patient and the caregiver. The training consists of two components: a cognitive and a physical component.
Behavioral: Fall prevention course
Duration: 5 weeks, 2 sessions of 2 hours per week: 10 sessions in total.
No Intervention: 2
- Falls incidence rate [ Time Frame: 6 months ]
- Burden for the caregiver [ Time Frame: 4 measurements within 6 months ]
- Quality of life (MOS-20) [ Time Frame: 4 measurements within 6 months ]
- Balance confidence [ Time Frame: 4 measurements within 6 months ]
- Depression and general anxiety [ Time Frame: 4 measurements within 6 months ]
- Functional performance and activities of daily living [ Time Frame: 4 measurements within 6 months ]
- Mood [ Time Frame: 4 measurements within 6 months ]
- Physical activity [ Time Frame: 4 measurements within 6 months ]
- Mobility [ Time Frame: 4 measurements within 6 months ]
- Balance [ Time Frame: 4 measurements within 6 months ]
- Cognition [ Time Frame: 4 measurements within 6 months ]
- Fear of falling (FES) [ Time Frame: 4 measurements within 6 months ]
- Mental well being [ Time Frame: 4 measurements within 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512655
|Radboud University Nijmegen Medical Centre|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Principal Investigator:||Prof. Dr. M. Olde Rikkert, MD PhD||Radboud University|