Falls (Accidents) in Old Age
Conditions
Brief summary
Approximately one in three older adults fall annually and it is the primary cause of traumatic injury in older adults. While exercise and balance programs have been shown to be effective in reducing fall risk, maintaining behavior change is known to be difficult. Thus additional interventions need to be validated to add to our current armamentarium to reduce falls in older adults. Cognitive training (CT) involves exercises that target specific cognitive tasks, such as memory or processing speed. It has been speculated that routinely performing such tasks may increase functional ability. Recent work has pointed to an increased risk of falls in community-dwelling older adults who have alterations in specific cognitive tasks. Thus the purpose of the proposed study is to demonstrate the feasibility and to explore the effectiveness of a 16 week CT intervention to reduce risk and incidence of fall and improve outcomes up to 1 month post-intervention in a group of community dwelling older adults at risk for fall.
Interventions
OTHERCognitive Training
Web-based cognitive training intervention targeting specific cognitive tasks. Subjects complete 3 training sessions per week with at least 24 hours in between sessions.
OTHERTechnology-based Education
Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection.
Sponsors
National Institute of Nursing Research (NINR)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* 65-89 years old * speak and read English * live within 30 miles of the University of Washington * a score of 4 or higher on the Memory Impairment Screen (MIS-T) * regular access to a computer with internet capability (whether at home, friend/family, community center, public library, or other) * a positive response to any of the following three fall related questions: i) Have you had two or more falls in the prior 12 months? ii) Are you responding to the advertisement because of a recent fall? iii) Do you have difficulty with walking or balance? * \<53 seconds on 90 second balance test or gait speed \<1m/sec.
Exclusion criteria
* current participation in formal cognitive training program * currently bedridden or wheelchair dependent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Falls | 16 weeks | Falls and Injurious Falls as per Fall Calendar |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability | 8 weeks, 16 weeks, 20 weeks. | Gill Disability Scale |
| Cognitive Assessment | 8 weeks, 16 weeks, 20 weeks | CANTAB Battery (Simple response time, one touch stockings of Cambridge, Stop Signal Task, Spatial Working Memory, Verbal Recognition Memory, Rapid Visual Information Processing) |
| Gait Assessment | 8 weeks, 16 weeks, 20 weeks | Assessment of Gait Parameters using APDM sensor system |
| Balance Assessment | 8 weeks, 16 weeks, 20 weeks | Assessment of Balance using APDM sensor system |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Cognitive Training: Web-based cognitive training intervention targeting specific cognitive tasks. Subjects complete 3 training sessions per week with at least 24 hours in between sessions. | 40 |
| Education Technology-based Education: Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Intervention | Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 40 Participants | 20 Participants | 60 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 77.2 years STANDARD_DEVIATION 7.1 | 75.9 years STANDARD_DEVIATION 6.6 | 76.8 years STANDARD_DEVIATION 6.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 19 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 38 Participants | 14 Participants | 52 Participants |
| Region of Enrollment United States | 40 participants | 20 participants | 60 participants |
| Sex: Female, Male Female | 28 Participants | 16 Participants | 44 Participants |
| Sex: Female, Male Male | 12 Participants | 4 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 20 |
| other Total, other adverse events | 0 / 40 | 0 / 20 |
| serious Total, serious adverse events | 0 / 40 | 0 / 20 |
Outcome results
Primary
Falls
Falls and Injurious Falls as per Fall Calendar
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Falls | 0.6 number of falls | Standard Error 0.2 |
| Education | Falls | 0.6 number of falls | Standard Error 0.3 |
Secondary
Balance Assessment
Assessment of Balance using APDM sensor system
Time frame: 8 weeks, 16 weeks, 20 weeks
Secondary
Cognitive Assessment
CANTAB Battery (Simple response time, one touch stockings of Cambridge, Stop Signal Task, Spatial Working Memory, Verbal Recognition Memory, Rapid Visual Information Processing)
Time frame: 8 weeks, 16 weeks, 20 weeks
Secondary
Disability
Gill Disability Scale
Time frame: 8 weeks, 16 weeks, 20 weeks.
Secondary
Gait Assessment
Assessment of Gait Parameters using APDM sensor system
Time frame: 8 weeks, 16 weeks, 20 weeks