Village Interactive Training and Learning Study

Aged Clinical Trial

— VITAL  

Official title:

The Village Interactive Training and Learning Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01709799
• Other study ID #: 179-2010
• Status: Completed
• Phase: N/A
• First received: September 18, 2012
• Last updated: June 3, 2015
• Start date: January 2010
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aged

Intervention

Behavioral:
• Exercise
Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula: (THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.
• Exergames
Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play. Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula: THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate Polar Heart Rate monitors are used to measure THR and save resulting data.
• Cognitive Training
Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16. INSIGHT Assessments are done at baseline, the start of each training week and at week 28.

Locations

Country	Name	City	State
United States	The Village Retirement Community	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bird Safari Subtest of PositScience Insight	Participants identify the bird that is different from the others as it flashes briefly on screen. The test measures visual speed and precision. The test is adaptive, and becomes more difficult with practice in that bird pairs get more similar, backgrounds get more complex, and distance from the center increases. The raw score is in milliseconds. As participants improve, the birds flash for fewer milliseconds, giving them a lower (better) score. Thus, LOWER SCORES reflect IMPROVEMENT; These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was: T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)	Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)	No
Primary	Jewel Diver Subtest of PositScience Insight	Participants track target objects as they move around the screen. This is a measure of divided attention. As participants master the task, it is made more difficult in that: (a) objects travel more quickly, (b) objects travel over larger area, (c) objects travel for longer, (d) visual contrast decreases. The score is the number of objects participants are able to track. Thus, HIGHER SCORES reflect IMPROVEMENT; These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was: T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)	Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)	No
Primary	Master Gardener Subtest of PositScience Insight	Participants watch as three or five images briefly flash in different positions on screen. This task measures visual processing speed and visual working memory. As participants master the task, it is made more difficult via: (a) the images change, becoming more similar, (b) the images are shown over a larger area on screen, and (c) participants go from viewing 3 images to 5 images. Participant score is in milliseconds, so that as they improve, the images flash on screen for fewer milliseconds. Thus LOWER SCORES are indicative of IMPROVEMENT.; These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was: T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)	Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)	No
Primary	Road Tour Subtest of PositScience Insight	Participants choose which car they saw at the center of the screen, and also locate where a "Route 66" sign appeared in the periphery. This is a measure of useful field of view and visual processing speed. As participants master the task, it is made more difficult via: (a) distractors are added, (b) distance from the center increases, (c) cars get more similar, and (d) backgrounds get more complex. Score is in milliseconds. As participants improve, the cars and road signs flash for fewer milliseconds, giving them a lower (better) score. Thus LOWER SCORES are indicative of IMPROVEMENT.; These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was: T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)	Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)	No
Primary	Sweep Seeker Subtest of PositScience Insight	Participants watch two patterns that "sweep" in or out and identify their direction. The test measures visual processing speed. As participants master the task it is made more difficult via: (a) the colors of the sweeps change, (b) the direction of the sweeps change, and (c) the thickness of the bars change. Participants' scores are in milliseconds. As participants improve, the visual sweeps speed up, giving participants a lower (better) score. Thus LOWER SCORES are indicative of IMPROVEMENT.; These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was: T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)	Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)	No
Secondary	Timed Instrumental Activities of Daily Living Task	The TIADL consists of five timed instrumental activities of daily (TIADL) tasks. The score that is generated is the total time required to perform the tasks (e.g., finding a telephone number, making change, finding and reading the ingredients on a can of food, finding food items on a shelf, reading instructions on medicine container). Thus LOWER SCORES are indicative of IMPROVEMENT.; These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was: T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)	Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)	No