Trial Outcomes & Findings for Village Interactive Training and Learning Study (NCT NCT01709799)
NCT ID: NCT01709799
Last Updated: 2015-06-22
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)
Results posted on
2015-06-22
Participant Flow
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.
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).
Participant milestones
| Measure |
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.
Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details.
|
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.
Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
21
|
18
|
|
Overall Study
COMPLETED
|
22
|
18
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Village Interactive Training and Learning Study
Baseline characteristics by cohort
| Measure |
Cognitive Training Plus Exercise
n=25 Participants
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.
|
Cognitive Training Plus Exergames
n=21 Participants
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.
|
Cognitive Training
n=18 Participants
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.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
61 Participants
n=483 Participants
|
|
Age, Continuous
|
79.6400 years
n=93 Participants
|
78.1905 years
n=4 Participants
|
77.2778 years
n=27 Participants
|
78.8133 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
44 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=93 Participants
|
21 participants
n=4 Participants
|
18 participants
n=27 Participants
|
64 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline (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)
Outcome measures
| Measure |
Cognitive Training Plus Exercise
n=25 Participants
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.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)
|
Cognitive Training Plus Exergames
n=21 Participants
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.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)
|
Cognitive Training
n=18 Participants
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.
|
|---|---|---|---|
|
Bird Safari Subtest of PositScience Insight
Bird Safari Time 1
|
50.043 T-score units
Standard Error 1.864
|
50.292 T-score units
Standard Error 1.987
|
49.570 T-score units
Standard Error 2.061
|
|
Bird Safari Subtest of PositScience Insight
Bird Safari Time 2
|
43.218 T-score units
Standard Error 1.953
|
43.474 T-score units
Standard Error 2.033
|
43.143 T-score units
Standard Error 2.107
|
|
Bird Safari Subtest of PositScience Insight
Bird Safari Time 3
|
42.671 T-score units
Standard Error 1.997
|
43.610 T-score units
Standard Error 2.114
|
42.638 T-score units
Standard Error 2.182
|
PRIMARY outcome
Timeframe: Baseline (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)
Outcome measures
| Measure |
Cognitive Training Plus Exercise
n=25 Participants
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.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)
|
Cognitive Training Plus Exergames
n=21 Participants
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.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)
|
Cognitive Training
n=18 Participants
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.
|
|---|---|---|---|
|
Jewel Diver Subtest of PositScience Insight
Jewel Diver Time 1
|
48.940 T-score units
Standard Error 2.057
|
51.052 T-score units
Standard Error 2.202
|
50.570 T-score units
Standard Error 2.274
|
|
Jewel Diver Subtest of PositScience Insight
Jewel Diver Time 2
|
63.872 T-score units
Standard Error 2.139
|
61.577 T-score units
Standard Error 2.233
|
63.205 T-score units
Standard Error 2.332
|
|
Jewel Diver Subtest of PositScience Insight
Jewel Diver Time 3
|
62.033 T-score units
Standard Error 2.139
|
61.121 T-score units
Standard Error 2.318
|
64.460 T-score units
Standard Error 2.467
|
PRIMARY outcome
Timeframe: Baseline (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)
Outcome measures
| Measure |
Cognitive Training Plus Exercise
n=25 Participants
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.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)
|
Cognitive Training Plus Exergames
n=21 Participants
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.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)
|
Cognitive Training
n=18 Participants
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.
|
|---|---|---|---|
|
Master Gardener Subtest of PositScience Insight
Master Gardener Time 1
|
49.938 T-score units
Standard Error 1.618
|
50.082 T-score units
Standard Error 1.731
|
49.833 T-score units
Standard Error 1.788
|
|
Master Gardener Subtest of PositScience Insight
Master Gardener Time 2
|
44.600 T-score units
Standard Error 1.650
|
44.851 T-score units
Standard Error 1.739
|
44.542 T-score units
Standard Error 1.838
|
|
Master Gardener Subtest of PositScience Insight
Master Gardener Time 3
|
44.700 T-score units
Standard Error 1.685
|
46.896 T-score units
Standard Error 1.781
|
44.759 T-score units
Standard Error 1.954
|
PRIMARY outcome
Timeframe: Baseline (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)
Outcome measures
| Measure |
Cognitive Training Plus Exercise
n=25 Participants
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.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)
|
Cognitive Training Plus Exergames
n=21 Participants
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.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)
|
Cognitive Training
n=18 Participants
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.
|
|---|---|---|---|
|
Road Tour Subtest of PositScience Insight
Road Tour Time 1
|
50.097 T-score units
Standard Error 1.540
|
53.424 T-score units
Standard Error 1.661
|
47.427 T-score units
Standard Error 1.703
|
|
Road Tour Subtest of PositScience Insight
Road Tour Time 2
|
40.279 T-score units
Standard Error 1.582
|
37.197 T-score units
Standard Error 1.669
|
36.622 T-score units
Standard Error 1.797
|
|
Road Tour Subtest of PositScience Insight
Road Tour Time 3
|
40.032 T-score units
Standard Error 1.604
|
38.803 T-score units
Standard Error 1.755
|
36.691 T-score units
Standard Error 1.916
|
PRIMARY outcome
Timeframe: Baseline (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)
Outcome measures
| Measure |
Cognitive Training Plus Exercise
n=25 Participants
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.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)
|
Cognitive Training Plus Exergames
n=21 Participants
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.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)
|
Cognitive Training
n=18 Participants
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.
|
|---|---|---|---|
|
Sweep Seeker Subtest of PositScience Insight
Sweep Seeker Time 1
|
51.002 T-score units
Standard Error 1.641
|
48.784 T-score units
Standard Error 1.776
|
49.505 T-score units
Standard Error 1.814
|
|
Sweep Seeker Subtest of PositScience Insight
Sweep Seeker Time 2
|
43.846 T-score units
Standard Error 1.743
|
44.003 T-score units
Standard Error 1.929
|
42.021 T-score units
Standard Error 1.884
|
|
Sweep Seeker Subtest of PositScience Insight
Sweep Seeker Time 3
|
42.231 T-score units
Standard Error 1.805
|
44.997 T-score units
Standard Error 1.928
|
43.304 T-score units
Standard Error 2.051
|
SECONDARY outcome
Timeframe: Baseline (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)
Outcome measures
| Measure |
Cognitive Training Plus Exercise
n=25 Participants
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.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)
|
Cognitive Training Plus Exergames
n=21 Participants
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.
Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)
|
Cognitive Training
n=18 Participants
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.
|
|---|---|---|---|
|
Timed Instrumental Activities of Daily Living Task
Timed IADL Time 1
|
52.065 T-score units
Standard Error 2.710
|
49.084 T-score units
Standard Error 2.956
|
48.094 T-score units
Standard Error 3.286
|
|
Timed Instrumental Activities of Daily Living Task
Timed IADL Time 2
|
51.040 T-score units
Standard Error 2.861
|
47.540 T-score units
Standard Error 3.018
|
46.948 T-score units
Standard Error 3.465
|
|
Timed Instrumental Activities of Daily Living Task
Timed IADL Time 3
|
57.284 T-score units
Standard Error 3.033
|
46.941 T-score units
Standard Error 3.146
|
47.095 T-score units
Standard Error 3.465
|
Adverse Events
Cognitive Training Plus Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Training Plus Exergames
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cognitive Training Plus Exercise
n=25 participants at risk
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.
Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details.
|
Cognitive Training Plus Exergames
n=21 participants at risk
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.
Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details.
|
Cognitive Training
n=18 participants at risk
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.
|
|---|---|---|---|
|
General disorders
363801007 Observable feature of falls
|
0.00%
0/25 • 5 years
|
4.8%
1/21 • Number of events 1 • 5 years
|
0.00%
0/18 • 5 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place