Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized Controlled Trial to Reduce Falls Incidence Rate in Frail Elderly
Brief Summary: 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.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Other: multifactorial intervention | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Other: Usual care | Intervention Type: OTHER; Name: multifactorial intervention; Assigned to Arm(s): 1 | Intervention Type: OTHER; Name: Usual care; Assigned to Arm(s): 2
B: Intervention Type: BEHAVIORAL; Name: physical exercise, wellness; Assigned to Arm(s): N/A
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise Training | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise training | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise training | Intervention Type: BEHAVIORAL; Name: Exercise Training; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Exercise training; Assigned to Arm(s): 2 | Intervention Type: BEHAVIORAL; Name: Exercise training; Assigned to Arm(s): 3
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Fall prevention course | Arm Label: 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Fall prevention course; Assigned to Arm(s): 1

Answer: D