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CompletedNCT01709799VITALUpdated Jun 22, 2015Results posted

Village Interactive Training and Learning Study

An interventional study of Exercise and Exergames in Aged, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 60 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-22.

Sponsored by University of Florida · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
60 Years to 95 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Aged

Keywords

  • Cognitive Training
  • Aging
  • Seniors
03

In context

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

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

    Behavioral: Exercise · Behavioral: Cognitive Training

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

    Behavioral: Exergames · Behavioral: Cognitive Training

  • Active comparator
    Cognitive Training

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

    Behavioral: Cognitive Training

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.

06

What researchers measure

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Secondary outcomes

  1. 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)

07

Results

Posted Jun 22, 2015

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.

Participant flow — Overall Study
MilestoneCognitive Training Plus ExerciseCognitive Training Plus ExergamesCognitive Training
Started252118
Completed221815
Not completed333

Outcome measures

PrimaryBird 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)
Reported as:
Mean · T-score units
Bird Safari Subtest of PositScience Insight
T-score unitsCognitive Training Plus ExerciseCognitive Training Plus ExergamesCognitive Training
Bird Safari Time 150.043 ± 1.86450.292 ± 1.98749.570 ± 2.061
Bird Safari Time 243.218 ± 1.95343.474 ± 2.03343.143 ± 2.107
Bird Safari Time 342.671 ± 1.99743.610 ± 2.11442.638 ± 2.182
Statistical analysis
  • Cognitive Training Plus Exercise vs Cognitive Training Plus Exergames vs Cognitive Training · Mixed Models Analysis · p = < .001 (P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance)degrees of freedom are (2,90.577)
  • Cognitive Training Plus Exercise vs Cognitive Training Plus Exergames vs Cognitive Training · Mixed Models Analysis · p = 0.995 (The p-value is not adjusted for multiple comparisons, and the a priori threshold for statistical significance was 0.05)Degrees of freedom are (4,90.564)
PrimaryJewel 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)
Reported as:
Mean · T-score units
Jewel Diver Subtest of PositScience Insight
T-score unitsCognitive Training Plus ExerciseCognitive Training Plus ExergamesCognitive Training
Jewel Diver Time 148.940 ± 2.05751.052 ± 2.20250.570 ± 2.274
Jewel Diver Time 263.872 ± 2.13961.577 ± 2.23363.205 ± 2.332
Jewel Diver Time 362.033 ± 2.13961.121 ± 2.31864.460 ± 2.467
Statistical analysis
  • Cognitive Training Plus Exercise vs Cognitive Training Plus Exergames vs Cognitive Training · Mixed Models Analysis · p = <.001 (P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance)degrees of freedom are (2,97.137)
  • Cognitive Training Plus Exercise vs Cognitive Training Plus Exergames vs Cognitive Training · Mixed Models Analysis · p = 0.254 (P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance)degrees of freedom are (4,97.108)
PrimaryMaster 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)
Reported as:
Mean · T-score units
Master Gardener Subtest of PositScience Insight
T-score unitsCognitive Training Plus ExerciseCognitive Training Plus ExergamesCognitive Training
Master Gardener Time 149.938 ± 1.61850.082 ± 1.73149.833 ± 1.788
Master Gardener Time 244.600 ± 1.65044.851 ± 1.73944.542 ± 1.838
Master Gardener Time 344.700 ± 1.68546.896 ± 1.78144.759 ± 1.954
Statistical analysis
  • Cognitive Training Plus Exercise vs Cognitive Training Plus Exergames vs Cognitive Training · Mixed Models Analysis · p = <0.001 (P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance)degrees of freedom are (2,99.647)
  • Cognitive Training Plus Exercise vs Cognitive Training Plus Exergames vs Cognitive Training · Mixed Models Analysis · p = 0.781 (P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance)degrees of freedom are (4,99.601)
PrimaryRoad 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)
Reported as:
Mean · T-score units
Road Tour Subtest of PositScience Insight
T-score unitsCognitive Training Plus ExerciseCognitive Training Plus ExergamesCognitive Training
Road Tour Time 150.097 ± 1.54053.424 ± 1.66147.427 ± 1.703
Road Tour Time 240.279 ± 1.58237.197 ± 1.66936.622 ± 1.797
Road Tour Time 340.032 ± 1.60438.803 ± 1.75536.691 ± 1.916
Statistical analysis
  • Cognitive Training Plus Exercise vs Cognitive Training Plus Exergames vs Cognitive Training · Mixed Models Analysis · p = <0.001 (P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance)degrees of freedom are (2,102.315)
  • Cognitive Training Plus Exercise vs Cognitive Training Plus Exergames vs Cognitive Training · Mixed Models Analysis · p = 0.026 (P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance)degrees of freedom are (4,102.216)
PrimarySweep 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)
Reported as:
Mean · T-score units
Sweep Seeker Subtest of PositScience Insight
T-score unitsCognitive Training Plus ExerciseCognitive Training Plus ExergamesCognitive Training
Sweep Seeker Time 151.002 ± 1.64148.784 ± 1.77649.505 ± 1.814
Sweep Seeker Time 243.846 ± 1.74344.003 ± 1.92942.021 ± 1.884
Sweep Seeker Time 342.231 ± 1.80544.997 ± 1.92843.304 ± 2.051
Statistical analysis
  • Cognitive Training Plus Exercise vs Cognitive Training Plus Exergames vs Cognitive Training · Mixed Models Analysis · p = <0.001 (P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance)degrees of freedom are (2,93.240)
  • Cognitive Training Plus Exercise vs Cognitive Training Plus Exergames vs Cognitive Training · Mixed Models Analysis · p = 0.313 (P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance)degrees of freedom are (4,93.167)
SecondaryTimed 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)
Reported as:
Mean · T-score units
Timed Instrumental Activities of Daily Living Task
T-score unitsCognitive Training Plus ExerciseCognitive Training Plus ExergamesCognitive Training
Timed IADL Time 152.065 ± 2.71049.084 ± 2.95648.094 ± 3.286
Timed IADL Time 251.040 ± 2.86147.540 ± 3.01846.948 ± 3.465
Timed IADL Time 357.284 ± 3.03346.941 ± 3.14647.095 ± 3.465
Statistical analysis
  • Cognitive Training Plus Exercise vs Cognitive Training Plus Exergames vs Cognitive Training · Mixed Models Analysis · p = 0.630 (P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance)degrees of freedom are (2,115.573)
  • Cognitive Training Plus Exercise vs Cognitive Training Plus Exergames vs Cognitive Training · Mixed Models Analysis · p = 0.498 (P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance)degrees of freedom are (4,115.593)

Adverse events

Collected over 5 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cognitive Training Plus Exercise—0/25 (0%)0/25 (0%)
Cognitive Training Plus Exergames—1/21 (4.8%)0/21 (0%)
Cognitive Training—0/18 (0%)0/18 (0%)
Most frequent serious events
Most frequent serious events
EventCognitive Training Plus ExerciseCognitive Training Plus ExergamesCognitive Training
363801007 Observable feature of fallsGeneral disorders0/251/210/18

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Cognitive Training Plus ExerciseCognitive Training Plus ExergamesCognitive TrainingTotal
<=18 years0000
Between 18 and 65 years2103
>=65 years23201861
Age, Continuous
Age, Continuous(years)Cognitive Training Plus ExerciseCognitive Training Plus ExergamesCognitive TrainingTotal
Mean79.6400 (62 to 93)78.1905 (60 to 89)77.2778 (65 to 88)78.8133 (60 to 93)
Sex: Female, Male
Sex: Female, Male(Participants)Cognitive Training Plus ExerciseCognitive Training Plus ExergamesCognitive TrainingTotal
Female2213944
Male38920
Region of Enrollment
Region of Enrollment(participants)Cognitive Training Plus ExerciseCognitive Training Plus ExergamesCognitive TrainingTotal
United States25211864
08

Study locations

1 site
  • The Village Retirement Community
    Gainesville, Florida 32653, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01709799
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
Oct 18, 2012
Start date
Jan 2010
Primary completion
May 2015
Completion
May 2015
Results posted
Jun 22, 2015
Last update
Jun 22, 2015

Study contacts

Dawn Bowers, Ph.D.
principal investigator · University of Florida- PHHP, CHP
Michael M Marsiske, Ph.D.
principal investigator · University of Florida, PHHP, CHP

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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