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Combined Exercise and Cognitive Stimulation for Falls Prevention

NCT04911179 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2021-06-02

No results posted yet for this study

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 Sebastián, 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.

Conditions

  • Fall
  • Frailty
  • Cognition Disorders in Old Age
  • Exercise
  • Cognitive Change

Interventions

OTHER

Vivfrail-Cog combined multicomponent physical exercise and cognitive stimulation.

The areas to be worked on are: Attentional system: selective attention and concentration; alternating attention / dual attention; Processing speed; perceptual organization; working memory and cognitive flexibility; comprehension, abstraction and verbal reasoning, planning, execution, and problem solving. Four programs have been developed stimulation different difficulty levels to adapt to the capabilities of each participant.

Sponsors & Collaborators

  • Fundacion Miguel Servet

    lead OTHER

Principal Investigators

  • Álvaro Casas Herrero, MD PhD · Fundación Miguel Servet - Navarrabiomed

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2024-03-01
Completion
2024-04-01

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04911179 on ClinicalTrials.gov