Aged
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical study. Community-dwelling older people at a high risk of falls will be distributed into two groups (Intervention Group and Control Group
Sponsors
Centro de Ciências Biológicas e da Saúde
Centro de Ciências Biológicas e da Saúde
Eligibility
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: Level of consciousness that allows the volunteer to be an active subject in the intervention; both genders; aged over 60 yeas; high risk of falls according to the global recommendation for the prevention and management of falls in older people (older people with a history of at least 1 fall in the last year and one or more of the following characteristics: injurious fall; =2 falls in the last year; presence of frailty syndrome; inability to get up after a fall without help for at least one hour; and fall accompanied by suspected transient loss of consciousness); ability to walk alone with or without a walking aid); and willingness to participate in the proposed assessments and interventions
Exclusion criteria
Exclusion criteria: Severe and uncorrected hearing and visual impairment that makes communication difficult during the intervention; presenting neurological diseases that rapidly modify the risk of falls (multiple sclerosis; diagnosis of moderate to advanced dementia; epilepsy; and traumatic brain injury; or taking associated medications); and presenting some contraindication to physical exercise (acute infectious disease; dissecting aortic aneurysm; severe aortic stenosis; congestive heart failure/unstable angina; acute myocardial infarction; acute myocarditis; acute pulmonary or systemic embolism; thrombophlebitis; ventricular tachycardia; and other dangerous arrhythmias)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of falls assessed by telephone calls once a month, in 16 weeks of intervention, 6 months and 12 months of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Neuropsychological risk factors will be assessed at baseline, after 16 weeks of intervention, and at 6 months and 12 months of follow-up. Cognition will be assessed by the ACE-R, Brief Cognitive Screening Battery, Digit Span and dual-task test. If functional near-infrared spectroscopy (fNIRS) is possible, prefrontal cortex activity will be assessed along with the dual-task test. The abbreviated GDS, GAI, and FES-I will be used to assess behavioral symptoms. The Global Rating Change Scale (GRCS) will be used to assess MCID.;Motor risk factors will be assessed at baseline, after 16 weeks of intervention, 6 months and 12 months of follow-up. Physical activity level will be assessed by QBMI, functional mobility by SPPB and TUG and sarcopenia by calf circumference and handgrip strength.;Adherence will be assessed by the volunteer's weekly attendance at the interventions. A questionnaire will also be used at the end of the 16 weeks to assess the reasons for adherence to the intervention (facilitators) and the reasons for non-adherence to the intervention (barriers). The questionnaires involve binary questions (yes/no) and a free space for speaking/writing. In addition, the prevalence of each recommendation given and the adherence (process of acceptance and initiation of care) of the participants to these recommendations will be assessed (3-point scale: completed as recommended, partially completed, not completed) after 16 weeks of intervention, 6 months and 12 months of follow-up. Regarding satisfaction with the interventions, after 16 weeks, a questionnaire based on the Short Assessment of Patient Satisfaction (SAPS) will be used.;Other potentially modifiable risk factors will be assessed in the initial period, after 16 weeks of intervention, 6 months and 12 months of follow-up, including nutritional aspects (body mass index, nutritional status, blood test, Mini-Nutritional Assessment), use of medications, assessment of general health, functional aspects (Lawton), visua | — |
Countries
Brazil
Contacts
Public ContactJuliana Ansai
Universidade Federal de São Carlos
Outcome results
None listed