Village Interactive Training and Learning Study

NCT01709799 | Completed Results

• 1 other identifier: 179-2010
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Aged

Keywords

Cognitive Training; Aging; Seniors

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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)

Secondary Outcomes (1)

• Timed Instrumental Activities of Daily Living Task

  Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)

Study Arms (3)

Cognitive Training plus Exercise

EXPERIMENTAL

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.) Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training.

Behavioral: Exercise; Behavioral: Cognitive Training

Cognitive Training plus Exergames

ACTIVE COMPARATOR

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. Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training.

Behavioral: Exergames; Behavioral: Cognitive Training

Cognitive Training

ACTIVE COMPARATOR

Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.

Behavioral: Cognitive Training

Interventions

Exercise BEHAVIORAL

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.

Cognitive Training plus Exercise

Exergames BEHAVIORAL

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 plus Exergames

Cognitive Training BEHAVIORAL

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.

Cognitive Training; Cognitive Training plus Exercise; Cognitive Training plus Exergames

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

The Village Retirement Community

Gainesville, Florida, 32653, United States

Location

MeSH Terms

Interventions

Exercise; Exergaming; Cognitive Training

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Dawn Bowers
• Organization: University of Florida

dawnbowers@phhp.ufl.edu

(352) 392-3450

Study Officials

• Dawn Bowers, Ph.D.

  University of Florida- PHHP, CHP

  PRINCIPAL INVESTIGATOR

• Michael M Marsiske, Ph.D.

  University of Florida, PHHP, CHP

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: October 18, 2012
• Study Start: January 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 22, 2015
• Results First Posted: June 22, 2015

Record last verified: 2015-06

Locations

US (1)