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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30537
Enrollment
320
Registered
2007-07-16
Start date
2007-05-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vallen falling fear of falling

Interventions

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

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients: -age: 70 years or older -experience of a fall at least once in the past 6 months -living in their own home or in a home for the aged -availability of a primary caregiver who cares for the subject at least once a week -ability to walk 15 meters independently (usage of a walking aid is permitted) -life expectancy of more than 6 months as judged by their geriatrician;Caregiver: - caring for the patient at least once a week - sufficient cognitive capacity to advise and supervise the patient during the training and fall registration;Additional inclusion criterion for variability measurements: Caregiver need to be 70 years or older.

Exclusion criteria

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;Additional criteria for patients: -suffering from Parkinson*s disease (Hoehn and Yahr rating scale score equal to or higher than 3) -severe cognitive impairment (MMSE cut off score equal to or less than 13 out of 30)

Design outcomes

Primary

MeasureTime frame
In patients the falls incidence rate, fear of falling (FES) and quality of life (MOS-20) are the primary outcome measures. Total observation time of falls will be 6 months after start of the intervention.

Secondary

MeasureTime frame
In patients the secondary outcome measures are fall risk, quality of life, balance confidence, depression and general anxiety, functional performance in activities of daily life, physical activity, mobility, gait parameters, body sway and biomarkers of endothelial function and frailty. For the caregiver the secondary outcome measures are sense of competence, caregiver*s burden and mood. Intraindividual variability of cognition, balance and gait in both patients and caregivers. Cost-effectiveness of the intervention.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)