- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00512655
Trial to Reduce Falls Incidence Rate in Frail Elderly (CP)
Randomized Controlled Trial to Reduce Falls Incidence Rate in Frail Elderly
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arnhem, Netherlands
- Rijnstate Ziekenhuis
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Nijmegen, Netherlands
- CWZ
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Gelderland
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Nijmegen, Gelderland, Netherlands, 6500 HB
- Radboud University Nijmegen Medical Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least one fall in the last 6 months
- Living in their own home or in a home for the aged
- Availability of a primary caregiver caring for the patient at least once a week
- Ability to walk 15 meters independently (use of a walking aid is permitted)
- Life expectancy of more than 6 months, as judged by their geriatrician
Exclusion Criteria:
- Dyads of patients and caregivers in whom outcome assessment is highly unlikely to succeed, for example because they proved not to be able to register falls in the three months before randomization, will be excluded
- MMSE score of less than 15
- On the waiting list for a nursing home
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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.
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Duration: 5 weeks, 2 sessions of 2 hours per week: 10 sessions in total.
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No Intervention: 2
Usual care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Falls incidence rate
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Burden for the caregiver
Time Frame: 4 measurements within 6 months
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4 measurements within 6 months
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Quality of life (MOS-20)
Time Frame: 4 measurements within 6 months
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4 measurements within 6 months
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Balance confidence
Time Frame: 4 measurements within 6 months
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4 measurements within 6 months
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Depression and general anxiety
Time Frame: 4 measurements within 6 months
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4 measurements within 6 months
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Functional performance and activities of daily living
Time Frame: 4 measurements within 6 months
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4 measurements within 6 months
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Mood
Time Frame: 4 measurements within 6 months
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4 measurements within 6 months
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Physical activity
Time Frame: 4 measurements within 6 months
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4 measurements within 6 months
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Mobility
Time Frame: 4 measurements within 6 months
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4 measurements within 6 months
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Balance
Time Frame: 4 measurements within 6 months
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4 measurements within 6 months
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Cognition
Time Frame: 4 measurements within 6 months
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4 measurements within 6 months
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Fear of falling (FES)
Time Frame: 4 measurements within 6 months
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4 measurements within 6 months
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Mental well being
Time Frame: 4 measurements within 6 months
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4 measurements within 6 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Prof. Dr. M. Olde Rikkert, MD PhD, Radboud University Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CP MM 19-08-12-05-30-08
- SNO-T-0601-60
- ZonMw 920-03-457
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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