Combined Exercise and Cognitive Stimulation for Falls Prevention

  • STATUS
    Recruiting
  • participants needed
    310
  • sponsor
    Fundacion Miguel Servet
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Updated on 3 June 2021
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Summary

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.

Details
Condition Fall, Cognition Disorders in Old Age, Exercise, Frailty, Cognitive Change
Age 75years - 100years
Treatment Vivfrail-Cog combined multicomponent physical exercise and cognitive stimulation.
Clinical Study IdentifierNCT04911179
SponsorFundacion Miguel Servet
Last Modified on3 June 2021

Eligibility

 Yes No Not Sure

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
self-reported falls in the previous year
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
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