RANDOMIZED CONTROLLED TRIAL TO REDUCE FALLS AND FEAR OF FALLING IN FRAIL ELDERLY
- Conditions
- vallenfallingfear of falling1000286110001474
- Registration Number
- NL-OMON30537
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 320
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.
-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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>In patients the falls incidence rate, fear of falling (FES) and quality of life<br /><br>(MOS-20) are the primary outcome measures. Total observation time of falls will<br /><br>be 6 months after start of the intervention.</p><br>
- Secondary Outcome Measures
Name Time Method <p>In patients the secondary outcome measures are fall risk, quality of life,<br /><br>balance confidence, depression and general anxiety, functional performance in<br /><br>activities of daily life, physical activity, mobility, gait parameters, body<br /><br>sway and biomarkers of endothelial function and frailty. For the caregiver the<br /><br>secondary outcome measures are sense of competence, caregiver*s burden and<br /><br>mood.<br /><br>Intraindividual variability of cognition, balance and gait in both patients and<br /><br>caregivers.<br /><br>Cost-effectiveness of the intervention.</p><br>