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Falls and Cognitive Training 2 (FaCT2) study protocol: a randomised controlled trial exploring cognitive training to reduce risk of falls in at-risk older adults
  1. Hilaire J Thompson1,2,
  2. Ellen McGough3,
  3. George Demiris4,5
  1. 1Biobehavioral Nursing and Health Informatics, University of Washington Seattle Campus, Seattle, Washington, USA
  2. 2Harborview Injury Prevention and Research Center, Seattle, Washington, USA
  3. 3Department of Rehabilitation Medicine, University of Washington Seattle Campus, Seattle, Washington, USA
  4. 4School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA
  5. 5Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA
  1. Correspondence to Dr Hilaire J Thompson, Biobehavioral Nursing and Health Informatics, University of Washington Seattle Campus, Seattle, WA 98195, USA; hilairet{at}uw.edu

Abstract

Background The primary cause of traumatic injury in older adults is fall. Recent reports suggest that cognitive function contributes significantly to fall risk. Therefore, by targeting cognitive function for intervention, we could potentially reduce the incidence of fall and injury.

Primary objective To explore the effectiveness of a 16-week cognitive training (CT) intervention to reduce risk and incidence of fall in community-dwelling older adults at risk for fall.

Outcomes Primary outcome is number of falls over a 16-week period (ascertained by fall calendar method). Secondary outcomes include: change fall risk as indicated by improvement in 10 m walk and 90 s balance tests.

Design/methods The design is a two-group randomised controlled trial. Eligible participants are older adults (aged 65–85) residing in the community who are at risk for fall based on physical performance testing. Following completion of 1-week run-in phase, participants are randomly allocated (1:2) to either a group that is assigned to attention control or to the group that receives CT intervention for a total of 16 weeks. Participants are followed for an additional 4 weeks after intervention. Mann-Whitney U test and Student’s t-test will be used to examine between-group differences using intention-to-treat analyses.

Discussion Limited evidence supports the potential of CT to improve cognition and gait, but no published study has evaluated whether such an intervention would reduce incidence of fall. The present trial is designed to provide initial answers to this question. CT may also improve functioning important in other activities (eg, driving), reducing overall risk of injury in elders.

Trial registration number NCT03190460.

  • falls
  • injury
  • aged
  • balance
  • gait
  • executive function
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Footnotes

  • Funding National Institute of Nursing Research R21NR01554.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval Human Subjects Division of the University of Washington (IRB No 50219).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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