Overview
Randomized clinical trial of 310 older adults over 75 years old recruited from the Falls
Units of Geriatric Departments in 4 three University Hospitals in Spain (Pamplona, San
Sebastin, Albacete and Barcelona). Participants who met inclusion criteria will be
randomized to the usual care group (Otago exercise program) or the Vivifrail-Cog Intervention
(a combination of physical exercise Vivifrail program and cognitive training). The main
objective of the present randomized clinical trial is to investigate the effect of the
combined intervention (exercise and cognitive intervention) in frail older participants
living in the community and at risk of falling. The main endpoint will be the rate of falling
in the following year. Secondary endpoints include physical performance, muscle strength,
cognitive performance, hospitalizations, institutionalization, depression and quality of
life.
Description
Usual care: subjects randomized to the usual care group will receive an evidence-based
multidisciplinary intervention tailored at reducing the fall risk (polypharmacy,
environmental intervention, physical exercise). Importantly, the Otago exercise program
(considered the standard physical exercise intervention) will be prescribed in this group.
Intervention group: subjects assigned to this intervention will engage in a multicomponent
intervention combining an exercise program, Vivifrail (A practical guide for prescribing a
Multicomponent Physical Training Program to prevent weakness and falls in people over 70,
more information at www.vivifrail.com) and a cognitive training. Vivifrail exercise program
combines resistance, endurance, balance and flexibility exercise tailored to the functional
level of the subjects, guaranteeing an individualized approach. Exercises progress in terms
of intensity and difficulty as the subject adapts to exercise. The cognitive stimulation
program combines exercises to work on different cognitive functions, mainly addressing
executive functions (attentional system, processing speed, perceptual organization, working
memory and cognitive flexibility, verbal comprehension, abstraction and reasoning, planning,
execution and problem solving ).
It lasts 12 weeks, two weekly sessions. It is divided into 4 levels in order to adapt the
intervention to participant's individual capacity, and the level can be adjusted throughout
the intervention.
Correct execution will be monitored by constant contact with relatives in charge of
supervising the exercise program, who will be familiarized with the intervention prior to
participation.
Eligibility
Inclusion Criteria:
- Age 75 years or older
- Referral to the Falls Unit
- Ability to ambulate independently with or without technical aids
- Barthel Index 60
- Pre-frailty (1-2 criteria) or Frailty according to the Frailty Phenotype by Fried et al
- Risk of falling according to following criteria:
- Gait disorders captured through physical performance measures (Time Up and Go Test 20 s and/or Gait Speed 0,8 m/s
- 2 self-reported falls in the previous year
- 1 self-reported falls requiring medical assistance
- Relative/caregiver willingness to supervise the exercise/cognitive stimulation sessions
- Capability and willingness to provide informed consent
Exclusion Criteria:
- Unwillingness to either complete the study requirements or to be randomized into the control or the intervention group
- Life expectancy 3 months
- Terminal illness
- No possibility of follow-up
- Institutionalization or awaiting institutionalization
- Major cognitive impairment DSM-V moderate or severe (CDR 2-3 /GDS 5-7)
- No ability to read and write
- Severe visual and hearing deficit
- Any contraindications for physical exercise or testing procedures, including but not limited to:
- myocardial infarction in the past 3 months
- unstable angina pectoris
- uncontrolled arrhythmia
- unstable cardiovascular disease or other unstable medical condition
- uncontrolled arterial hypertension
- recent pulmonary thromboembolism
- upper or lower extremity fracture in the past 3 months