Clinical trial NCT01709799: Village Interactive Training and Learning Study
Official title: The Village Interactive Training and Learning Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aged
Keywords: Cognitive Training
Aging
Seniors
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to help scientists and health care providers learn more about preventing dementia and brain disease in older adults. There is an urgent need to develop strategies to prevent or slow down memory loss and brain function decline in the elderly.

In this study, the investigators hope to learn how physical exercise and a brain training program work together to improve thinking and memory in older adults. Specifically, these aims include:

* Learning whether physical activities (like biking or treadmill walking or Wii Fit games) will help improve the benefits of a brain training program. Based on preliminary results and that in the literature, the investigators anticipate greater cognitive benefits in the Exercise + Cognitive training groups than the Cognitive Training alone group.
* To determine whether the benefits of adding exercise will occur quickly or develop more gradually over time. The investigators suspect that a major benefit of exercise pre-dosing will occur by the 12th week of the program.
* To examine whether Wii-Fit exercise games cause similar effects on brain training as traditional exercise programs such as biking or walking. Although several recent studies have raised questions about the true aerobic benefit of exergames such as Wii-Fit Plus, other evidence suggests that these weaker aerobic benefits may be offset by the greater novelty and interest level afforded by exergames.

Detailed description: Research Participants take part in a 16 week Wellness Program, which includes either traditional physical exercise with brain training(Group A), Wii exergaming with brain training(Group B) or brain training alone (Group C). Participants are randomly assigned to groups.

A comprehensive battery of neuropsychological tests, surveys and assessments are given prior to start of the intervention, at completion of the 16 weeks, and again 3 months post completion.

The program involves 4 days of physical activity each week for groups A \& B. The physical exercise/activity portion will involve warm up stretching and then either Group A-traditional exercise (like riding a stationary recumbent bicycle or walking on a treadmill), Group B- playing Nintendo Wii Exergames with a television based video game, or Group C- NO exercise at all.

Every 4th week the 16 week intervention period, all participants in all three groups will also complete 80 minutes of brain training activities each day of the week. This is in addition to the previously assigned physical activity for Groups A \& B. The brain training regimen consists of Posit Science Insight computer based brain games.

The Insight program consists of five different modules that focus on visual processing, attention, and memory. Each of the modules are described below:

1. Bird Safari: This module involves identifying and ordering simple visual stimuli that flash on a screen. The goal is to improve ability to respond quickly to visual stimuli and to segment rapidly changing visual pictures.
2. Jewel Diver: This module involves tracking objects as they become hidden by distractors. The goal is to improve ability of visual system to rapidly identify and discriminate objects in the visual periphery.
3. Master Gardener: This module involves visual working memory and matching pairs of pictures.
4. Road Tour: This is a simulated driving exercise that involves divided attention to oncoming cars and road signs. The goal is to improve ability of visual system to continuously track multiple objects against a field of distractors.
5. Sweep Seeker: In this exercise, participants identify complex moving visual stimuli. The goal is to improve rapid, sequential eye movements to salient visual targets, process relevant information and then make rapid decisions to identify, discriminate and classify targets.

Questionnaires regarding the participants mood before and after the brain training weekly are administered. In addition, brief questionnaires on attention and memory are given to measure thinking and memory progress.

Eligibility criteria: Inclusion Criteria:

* Age 60+
* Generally Healthy
* On stable does of medications
* Absence of significant behavioral or cognitive dysfunction

Exclusion Criteria:

* Significant cognitive or behavioral problems or symptoms
* History of falls \>2 in the past month
* Unstable medical conditions such as uncontrolled diabetes, uncontrolled cardiac disease, uncontrolled hypertension, or other that would increase risk of side effects performing physical activity
* History of substance abuse in last 6 months
* Known structural brain abnormality, previous major debilitating strokes or seizures, traumatic brain injury
* Had complete neuropsychological testing in the last 6 months
* Previous participation in cognitive or exercise training study within last 3 months
* Currently engaging in moderate to heavy exercise \>125 mins. week at 75% Target Heart Rate

Primary outcomes:
measure: Bird Safari Subtest of PositScience Insight
timeFrame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)
measure: Jewel Diver Subtest of PositScience Insight
timeFrame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)
measure: Master Gardener Subtest of PositScience Insight
timeFrame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)
measure: Road Tour Subtest of PositScience Insight
timeFrame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)
measure: Sweep Seeker Subtest of PositScience Insight
timeFrame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)
Secondary outcomes:
measure: Timed Instrumental Activities of Daily Living Task
timeFrame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: The Village Retirement Community
state: Florida
Study officials:
affiliation: University of Florida- PHHP, CHP
name: Dawn Bowers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida, PHHP, CHP
name: Michael M Marsiske, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: