AgedVITALNCT01709799
Village Interactive Training and Learning Study
A study testing Exercise, Exergames and Cognitive Training in people with Aged, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to help scientists and health care providers learn more about preventing dementia and brain disease in older adults. There is an urgent need to develop strategies to prevent or slow down memory loss and brain function decline in the elderly. Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aged
- What is being tested?
- Exercise, Exergames and Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60+
- Generally Healthy
- On stable does of medications
- Absence of significant behavioral or cognitive dysfunction
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Village Retirement Community
Gainesville, Florida, 32653
About this study
Official title: The Village Interactive Training and Learning Study
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:
- 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.
- 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.
- Master Gardener: This module involves visual working memory and matching pairs of pictures.
- 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.
- 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.
- Conditions
- Aged
- Being tested
- Exercise, Exergames, Cognitive Training
- Keywords
- Cognitive Training, Aging, Seniors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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.
ExergamesBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startJan 2010
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgedStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dawn Bowers, Ph.D., Principal investigator, University of Florida- PHHP, CHPMichael M Marsiske, Ph.D., Principal investigator, University of Florida, PHHP, CHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709799
- Sponsor's protocol ID
- 179-2010
- Acronym
- VITAL
- Status last verified
- Jun 2015
- First submitted
- 18 Sep 2012
- Last updated
- 22 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Village Interactive Training and Learning Study
- ClinicalTrials.gov ID
- NCT01709799
- Acronym / sponsor ID
- VITAL / 179-2010
- Conditions
- Aged
- Keywords
- Cognitive Training, Aging, Seniors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Posted 22 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- Master Gardener: This module involves visual working memory and matching pairs of pictures.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training plus Exercise | Experimental | Behavioral: Exercise, Behavioral: Cognitive TrainingPhysical 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. |
| Cognitive Training plus Exergames | Active comparator | Behavioral: Exergames, Behavioral: Cognitive TrainingPhysical 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. |
| Cognitive Training | Active comparator | Behavioral: Cognitive TrainingParticipants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 60+
- Generally Healthy
- On stable does of medications
- Absence of significant behavioral or cognitive dysfunction
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseParticipants 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. | Behavioural | Cognitive Training plus Exercise |
| ExergamesParticipants 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. | Behavioural | Cognitive Training plus Exergames |
| Cognitive TrainingPosit 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. | Behavioural | Cognitive Training, Cognitive Training plus Exercise, Cognitive Training plus Exergames |
Primary outcome
Bird Safari Subtest of PositScience Insight
Time frame: 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)
Jewel Diver Subtest of PositScience Insight
Time frame: 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)
Master Gardener Subtest of PositScience Insight
Time frame: 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)
Road Tour Subtest of PositScience Insight
Time frame: 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)
Sweep Seeker Subtest of PositScience Insight
Time frame: 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)
1 secondary outcome
Timed Instrumental Activities of Daily Living Task
Time frame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Bowers, Ph.D. principal investigator
University of Florida- PHHP, CHP
Michael M Marsiske, Ph.D. principal investigator
University of Florida, PHHP, CHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Exergames and Cognitive Training in people with Aged, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bird Safari Subtest of PositScience Insight (time frame: Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2015.