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Village Interactive Training and Learning Study

The Village Interactive Training and Learning Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01709799
Acronym
VITAL
Enrollment
64
Registered
2012-10-18
Start date
2010-01-31
Completion date
2015-05-31
Last updated
2015-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aged

Keywords

Cognitive Training, Aging, Seniors

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.

Interventions

BEHAVIORALExercise

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.

BEHAVIORALExergames

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.

BEHAVIORALCognitive 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.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 95 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Bird Safari Subtest of PositScience InsightBaseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)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)
Jewel Diver Subtest of PositScience InsightBaseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)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)
Master Gardener Subtest of PositScience InsightBaseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)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)
Road Tour Subtest of PositScience InsightBaseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)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)
Sweep Seeker Subtest of PositScience InsightBaseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)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)

Secondary

MeasureTime frameDescription
Timed Instrumental Activities of Daily Living TaskBaseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)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)

Countries

United States

Participant flow

Recruitment details

Participants in the VITAL study were all healthy elders aged 60 years or older. The VITAL participants were drawn from the independent living portion of the retirement community where the study was located as well as from the broader Gainesville community.

Pre-assignment details

Exclusion criteria included Mini Mental Status Examination scores less than 25, a diagnosis of dementia or neurologic condition, unstable medical conditions, low hearing or vision, inability to engage in physical exercise, or already active (for more that 125 minutes per week at 75% their maximum target heart rate).

Participants by arm

ArmCount
Cognitive Training Plus Exercise
Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.) 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. Participants also received cognitive training every fourth week. See Cognitive Training arm for description.
25
Cognitive Training Plus Exergames
Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes. 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. Participants also received cognitive training every fourth week. See Cognitive Training arm for description.
21
Cognitive Training
Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention. 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.
18
Total64

Baseline characteristics

CharacteristicCognitive Training Plus ExergamesCognitive TrainingCognitive Training Plus ExerciseTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
20 Participants18 Participants23 Participants61 Participants
Age, Categorical
Between 18 and 65 years
1 Participants0 Participants2 Participants3 Participants
Age, Continuous78.1905 years77.2778 years79.6400 years78.8133 years
Region of Enrollment
United States
21 participants18 participants25 participants64 participants
Sex: Female, Male
Female
13 Participants9 Participants22 Participants44 Participants
Sex: Female, Male
Male
8 Participants9 Participants3 Participants20 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 250 / 210 / 18
serious
Total, serious adverse events
0 / 251 / 210 / 18

Outcome results

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)

Time frame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Training Plus ExerciseBird Safari Subtest of PositScience InsightBird Safari Time 243.218 T-score unitsStandard Error 1.953
Cognitive Training Plus ExerciseBird Safari Subtest of PositScience InsightBird Safari Time 150.043 T-score unitsStandard Error 1.864
Cognitive Training Plus ExerciseBird Safari Subtest of PositScience InsightBird Safari Time 342.671 T-score unitsStandard Error 1.997
Cognitive Training Plus ExergamesBird Safari Subtest of PositScience InsightBird Safari Time 243.474 T-score unitsStandard Error 2.033
Cognitive Training Plus ExergamesBird Safari Subtest of PositScience InsightBird Safari Time 150.292 T-score unitsStandard Error 1.987
Cognitive Training Plus ExergamesBird Safari Subtest of PositScience InsightBird Safari Time 343.610 T-score unitsStandard Error 2.114
Cognitive TrainingBird Safari Subtest of PositScience InsightBird Safari Time 149.570 T-score unitsStandard Error 2.061
Cognitive TrainingBird Safari Subtest of PositScience InsightBird Safari Time 342.638 T-score unitsStandard Error 2.182
Cognitive TrainingBird Safari Subtest of PositScience InsightBird Safari Time 243.143 T-score unitsStandard Error 2.107
Comparison: Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)p-value: <0.001Mixed Models Analysis
Comparison: Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)p-value: 0.995Mixed Models Analysis
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)

Time frame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Training Plus ExerciseJewel Diver Subtest of PositScience InsightJewel Diver Time 263.872 T-score unitsStandard Error 2.139
Cognitive Training Plus ExerciseJewel Diver Subtest of PositScience InsightJewel Diver Time 148.940 T-score unitsStandard Error 2.057
Cognitive Training Plus ExerciseJewel Diver Subtest of PositScience InsightJewel Diver Time 362.033 T-score unitsStandard Error 2.139
Cognitive Training Plus ExergamesJewel Diver Subtest of PositScience InsightJewel Diver Time 261.577 T-score unitsStandard Error 2.233
Cognitive Training Plus ExergamesJewel Diver Subtest of PositScience InsightJewel Diver Time 151.052 T-score unitsStandard Error 2.202
Cognitive Training Plus ExergamesJewel Diver Subtest of PositScience InsightJewel Diver Time 361.121 T-score unitsStandard Error 2.318
Cognitive TrainingJewel Diver Subtest of PositScience InsightJewel Diver Time 150.570 T-score unitsStandard Error 2.274
Cognitive TrainingJewel Diver Subtest of PositScience InsightJewel Diver Time 364.460 T-score unitsStandard Error 2.467
Cognitive TrainingJewel Diver Subtest of PositScience InsightJewel Diver Time 263.205 T-score unitsStandard Error 2.332
Comparison: Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)p-value: <0.001Mixed Models Analysis
Comparison: Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)p-value: 0.254Mixed Models Analysis
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)

Time frame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Training Plus ExerciseMaster Gardener Subtest of PositScience InsightMaster Gardener Time 244.600 T-score unitsStandard Error 1.65
Cognitive Training Plus ExerciseMaster Gardener Subtest of PositScience InsightMaster Gardener Time 149.938 T-score unitsStandard Error 1.618
Cognitive Training Plus ExerciseMaster Gardener Subtest of PositScience InsightMaster Gardener Time 344.700 T-score unitsStandard Error 1.685
Cognitive Training Plus ExergamesMaster Gardener Subtest of PositScience InsightMaster Gardener Time 244.851 T-score unitsStandard Error 1.739
Cognitive Training Plus ExergamesMaster Gardener Subtest of PositScience InsightMaster Gardener Time 150.082 T-score unitsStandard Error 1.731
Cognitive Training Plus ExergamesMaster Gardener Subtest of PositScience InsightMaster Gardener Time 346.896 T-score unitsStandard Error 1.781
Cognitive TrainingMaster Gardener Subtest of PositScience InsightMaster Gardener Time 149.833 T-score unitsStandard Error 1.788
Cognitive TrainingMaster Gardener Subtest of PositScience InsightMaster Gardener Time 344.759 T-score unitsStandard Error 1.954
Cognitive TrainingMaster Gardener Subtest of PositScience InsightMaster Gardener Time 244.542 T-score unitsStandard Error 1.838
Comparison: Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)p-value: <0.001Mixed Models Analysis
Comparison: Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)p-value: 0.781Mixed Models Analysis
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)

Time frame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Training Plus ExerciseRoad Tour Subtest of PositScience InsightRoad Tour Time 240.279 T-score unitsStandard Error 1.582
Cognitive Training Plus ExerciseRoad Tour Subtest of PositScience InsightRoad Tour Time 150.097 T-score unitsStandard Error 1.54
Cognitive Training Plus ExerciseRoad Tour Subtest of PositScience InsightRoad Tour Time 340.032 T-score unitsStandard Error 1.604
Cognitive Training Plus ExergamesRoad Tour Subtest of PositScience InsightRoad Tour Time 237.197 T-score unitsStandard Error 1.669
Cognitive Training Plus ExergamesRoad Tour Subtest of PositScience InsightRoad Tour Time 153.424 T-score unitsStandard Error 1.661
Cognitive Training Plus ExergamesRoad Tour Subtest of PositScience InsightRoad Tour Time 338.803 T-score unitsStandard Error 1.755
Cognitive TrainingRoad Tour Subtest of PositScience InsightRoad Tour Time 147.427 T-score unitsStandard Error 1.703
Cognitive TrainingRoad Tour Subtest of PositScience InsightRoad Tour Time 336.691 T-score unitsStandard Error 1.916
Cognitive TrainingRoad Tour Subtest of PositScience InsightRoad Tour Time 236.622 T-score unitsStandard Error 1.797
Comparison: Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)p-value: <0.001Mixed Models Analysis
Comparison: Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)p-value: 0.026Mixed Models Analysis
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)

Time frame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Training Plus ExerciseSweep Seeker Subtest of PositScience InsightSweep Seeker Time 243.846 T-score unitsStandard Error 1.743
Cognitive Training Plus ExerciseSweep Seeker Subtest of PositScience InsightSweep Seeker Time 151.002 T-score unitsStandard Error 1.641
Cognitive Training Plus ExerciseSweep Seeker Subtest of PositScience InsightSweep Seeker Time 342.231 T-score unitsStandard Error 1.805
Cognitive Training Plus ExergamesSweep Seeker Subtest of PositScience InsightSweep Seeker Time 244.003 T-score unitsStandard Error 1.929
Cognitive Training Plus ExergamesSweep Seeker Subtest of PositScience InsightSweep Seeker Time 148.784 T-score unitsStandard Error 1.776
Cognitive Training Plus ExergamesSweep Seeker Subtest of PositScience InsightSweep Seeker Time 344.997 T-score unitsStandard Error 1.928
Cognitive TrainingSweep Seeker Subtest of PositScience InsightSweep Seeker Time 149.505 T-score unitsStandard Error 1.814
Cognitive TrainingSweep Seeker Subtest of PositScience InsightSweep Seeker Time 343.304 T-score unitsStandard Error 2.051
Cognitive TrainingSweep Seeker Subtest of PositScience InsightSweep Seeker Time 242.021 T-score unitsStandard Error 1.884
Comparison: Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)p-value: <0.001Mixed Models Analysis
Comparison: Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)p-value: 0.313Mixed Models Analysis
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)

Time frame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Training Plus ExerciseTimed Instrumental Activities of Daily Living TaskTimed IADL Time 251.040 T-score unitsStandard Error 2.861
Cognitive Training Plus ExerciseTimed Instrumental Activities of Daily Living TaskTimed IADL Time 152.065 T-score unitsStandard Error 2.71
Cognitive Training Plus ExerciseTimed Instrumental Activities of Daily Living TaskTimed IADL Time 357.284 T-score unitsStandard Error 3.033
Cognitive Training Plus ExergamesTimed Instrumental Activities of Daily Living TaskTimed IADL Time 247.540 T-score unitsStandard Error 3.018
Cognitive Training Plus ExergamesTimed Instrumental Activities of Daily Living TaskTimed IADL Time 149.084 T-score unitsStandard Error 2.956
Cognitive Training Plus ExergamesTimed Instrumental Activities of Daily Living TaskTimed IADL Time 346.941 T-score unitsStandard Error 3.146
Cognitive TrainingTimed Instrumental Activities of Daily Living TaskTimed IADL Time 148.094 T-score unitsStandard Error 3.286
Cognitive TrainingTimed Instrumental Activities of Daily Living TaskTimed IADL Time 347.095 T-score unitsStandard Error 3.465
Cognitive TrainingTimed Instrumental Activities of Daily Living TaskTimed IADL Time 246.948 T-score unitsStandard Error 3.465
Comparison: Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)p-value: 0.63Mixed Models Analysis
Comparison: Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)p-value: 0.498Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026