Cognitive FunctionNCT04404621
Computer Presented and Physical Exercises to Maintain Cognitive Function and Emotional Health in Older Adults
A study testing Physical exercise (PE) training and computer-based brain (CBB) in people with Cognitive Function and Depression in Old Age, run by Yale University at 1 site in United States.
Trial summary
The aim of this study is to investigate and compare how 18-weeks of computer-based brain training and physical exercise together can improve physical performance, cognitive function and mood in older adults in a cross-over design with participants randomized to receive the intervention first and then be assessed… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Depression in Old Age
- What is being tested?
- Physical exercise (PE) training and computer-based brain (CBB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2019to 12 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Associated with Whitney center as residents or participants in non-resident programs.
- Able to understand and read English.
Who cannot join
- Not able to sit in a chair independently.
- Not able to move both arms in simple movement sequence.
- Hearing and vision insufficient to do the computer exercises or follow the PE instructions.
- Not able to remember 3 movements in succession.
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
The aim of this study is to investigate and compare how 18-weeks of computer-based brain training and physical exercise together can improve physical performance, cognitive function and mood in older adults in a cross-over design with participants randomized to receive the intervention first and then be assessed before and after an 18 week period without intervention, or the reverse sequence.
Read the detailed description
The aim of this study is to investigate and compare how 18-weeks of computer-based brain training and physical exercise together can improve physical performance, cognitive function and mood in older adults in a cross-over design with participants randomized to receive the intervention first and then be assessed before and after an 18 week period without intervention, or the reverse sequence. 80 adults between the ages of 65 and 105 years old will be invited to participate. After providing informed consent, in the case of subjects who are living on units for individuals with memory or other cognitive compromise, after assent from the individual and approval from facility staff, subjects will be randomly assigned to either receive the intervention for 18 weeks and then be followed for an additional 18 weeks, or to be followed for 18 weeks without intervention and then do the intervention for 18 weeks. The intervention will consist of 18 weeks of 60-minute PE sessions 3-4 times/week and 25-minute CBB training sessions 3-4 times a week.
There will be 3 assessments of participants: before and after the first 18-week period and then again after the second 18-week period. Assessments will be done in 2 sessions over a total of 90 minutes and will include demographic, health, physical activity and social activity questionnaires as well as the self-report measures of cognitive function, emotional state and weekly activities; quantitative assessments of physical balance, strength, flexibility blood pressure and heart rate; and tests of cognitive function. Subject medications will be recorded at each assessment. The wait-list control group will receive the same assessments at the same time points.
- Conditions
- Cognitive Function, Depression in Old Age
- Being tested
- Physical exercise (PE) training and computer-based brain (CBB)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise (PE) training and computer-based brain (CBB)Behavioural
18 weeks of PE and CBB.
| Study group | Role | What they receive |
|---|---|---|
| Cross-Over Sequence A | Experimental | Participants in this arm will be randomized to receive the 18 week program first and be in treatment as usual comparison condition in the following 18 weeks. Receives: Behavioral: Physical exercise (PE) training and computer-based brain (CBB) |
| Cross-Over Sequence B | Experimental | Participants in this arm will be randomized to remain in treatment as usual during the first 18 week period and then receive the 18 week program during the following 18 weeks. Receives: Behavioral: Physical exercise (PE) training and computer-based brain (CBB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite cognition score
Composite from: Flanker Test of Attention; Go/No-Go Test of Response Inhibition; List Sort Working Memory Test; Logical Memory Story Recall; Digit symbol coding; Digit Span Forwards and Backwards; Hopkin's Verbal Learning Test; Trail Making B; Stroop Color Word; Category Verbal Fluency; Reaction Time.
A composite score will be calculated for each participant at baseline and after training and waitlist periods by first determining Z-scores for each test for each participant at each time point based on means and standard deviations for the entire sample at baseline, and then averaging the individual's Z-scores at that time point.
Measured: 18 weeks
Sit to Stand in one-minute
Number of times able to go from sit to stand in in one minute
Measured: 18 weeks
Balance - stand on one foot at a time
Stand on one foot with the toe of the other foot touching the calf of the standing leg - number of seconds able to maintain. The sum of right and leg foot will be added.
Measured: 18 weeks
Mood and Quality of Life
Composite score from WHODAS, DEMQ QLI and Beck Depression Inventory.
A composite score will be calculated for each participant at baseline and after training and waitlist periods by first determining Z-scores for total score on each questionnaire for each participant at each time point based on means and standard deviations for the entire sample at baseline, and then averaging the individual's Z-scores at that time point.
Measured: 18 weeks
Secondary outcomes (6)
Attention and Speed of Processing
Flanker Test of Attention (average reaction time on correct incongruent trials)
Measured: 18 weeks
Response Inhibition
Percent correct on no-go trials on Go/No-Go Test
Measured: 18 weeks
Working Memory
Average z-scores on two tests of working memory: 1)List Sorting Working Memory (total score which is the sum of scores on parts one and two) and Digit Span (sum of longest span forward and longest span backwards)
Measured: 18 weeks
Verbal Memory
Logical Memory Story Recall (number of details correctly recalled on initial recall)
Measured: 18 weeks
Speed of Processing
Digit Symbol Coding (number of correct responses in 60 seconds)
Measured: 18 weeks
Cognitive Flexibility
Color/Word Stroop Test (Time to read words in conflicting colors minus time to read words without conflicting colors
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start13 Nov 2019
- Primary completion12 Sep 2020
- Study completion12 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce E Wexler, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404621
- Sponsor's protocol ID
- 2000026437
- Status last verified
- Jun 2021
- First submitted
- 22 May 2020
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Presented and Physical Exercises to Maintain Cognitive Function and Emotional Health in Older Adults
- ClinicalTrials.gov ID
- NCT04404621
- Acronym / sponsor ID
- 2000026437
- Conditions
- Cognitive Function, Depression in Old Age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 12 Sep 2020 (actual)
- Study completion
- 12 Sep 2020 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate and compare how 18-weeks of computer-based brain training and physical exercise together can improve physical performance, cognitive function and mood in older adults in a cross-over design with participants randomized to receive the intervention first and then be assessed before and after an 18 week period without intervention, or the reverse sequence.
Detailed description
The aim of this study is to investigate and compare how 18-weeks of computer-based brain training and physical exercise together can improve physical performance, cognitive function and mood in older adults in a cross-over design with participants randomized to receive the intervention first and then be assessed before and after an 18 week period without intervention, or the reverse sequence. 80 adults between the ages of 65 and 105 years old will be invited to participate. After providing informed consent, in the case of subjects who are living on units for individuals with memory or other cognitive compromise, after assent from the individual and approval from facility staff, subjects will be randomly assigned to either receive the intervention for 18 weeks and then be followed for an additional 18 weeks, or to be followed for 18 weeks without intervention and then do the intervention for 18 weeks. The intervention will consist of 18 weeks of 60-minute PE sessions 3-4 times/week and 25-minute CBB training sessions 3-4 times a week.
There will be 3 assessments of participants: before and after the first 18-week period and then again after the second 18-week period. Assessments will be done in 2 sessions over a total of 90 minutes and will include demographic, health, physical activity and social activity questionnaires as well as the self-report measures of cognitive function, emotional state and weekly activities; quantitative assessments of physical balance, strength, flexibility blood pressure and heart rate; and tests of cognitive function. Subject medications will be recorded at each assessment. The wait-list control group will receive the same assessments at the same time points.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross-Over Sequence A | Experimental | Behavioral: Physical exercise (PE) training and computer-based brain (CBB)Participants in this arm will be randomized to receive the 18 week program first and be in treatment as usual comparison condition in the following 18 weeks. |
| Cross-Over Sequence B | Experimental | Behavioral: Physical exercise (PE) training and computer-based brain (CBB)Participants in this arm will be randomized to remain in treatment as usual during the first 18 week period and then receive the 18 week program during the following 18 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Associated with Whitney center as residents or participants in non-resident programs.
- Able to understand and read English.
Key exclusion criteria (4 listed)
- Not able to sit in a chair independently.
- Not able to move both arms in simple movement sequence.
- Hearing and vision insufficient to do the computer exercises or follow the PE instructions.
- Not able to remember 3 movements in succession.
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 |
|---|---|---|
| Physical exercise (PE) training and computer-based brain (CBB)18 weeks of PE and CBB. | Behavioural | Cross-Over Sequence A, Cross-Over Sequence B |
Primary outcome
Composite cognition score
Time frame: 18 weeks
Composite from: Flanker Test of Attention; Go/No-Go Test of Response Inhibition; List Sort Working Memory Test; Logical Memory Story Recall; Digit symbol coding; Digit Span Forwards and Backwards; Hopkin's Verbal Learning Test; Trail Making B; Stroop Color Word; Category Verbal Fluency; Reaction Time. A composite score will be calculated for each participant at baseline and after training and waitlist periods by first determining Z-scores for each test for each participant at each time point based on means and standard deviations for the entire sample at baseline, and then averaging the individual's Z-scores at that time point.
Sit to Stand in one-minute
Time frame: 18 weeks
Number of times able to go from sit to stand in in one minute
Balance - stand on one foot at a time
Time frame: 18 weeks
Stand on one foot with the toe of the other foot touching the calf of the standing leg - number of seconds able to maintain. The sum of right and leg foot will be added.
Mood and Quality of Life
Time frame: 18 weeks
Composite score from WHODAS, DEMQ QLI and Beck Depression Inventory. A composite score will be calculated for each participant at baseline and after training and waitlist periods by first determining Z-scores for total score on each questionnaire for each participant at each time point based on means and standard deviations for the entire sample at baseline, and then averaging the individual's Z-scores at that time point.
6 secondary outcomes
Attention and Speed of Processing
Time frame: 18 weeks
Response Inhibition
Time frame: 18 weeks
Working Memory
Time frame: 18 weeks
Verbal Memory
Time frame: 18 weeks
Speed of Processing
Time frame: 18 weeks
Cognitive Flexibility
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Cognitive Function
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
RecruitingPhase 2/3
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Huntington Disease
RecruitingPhase 1
Acute Effects of Cannabis on Cognition and Affect
Cannabis Use
Active, not recruiting
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
Stroke, Cognitive Dysfunction
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
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.
Bruce E Wexler principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise (PE) training and computer-based brain (CBB) in people with Cognitive Function and Depression in Old Age, run by Yale University 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 2 inclusion and 4 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 14 Jun 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite cognition score (time frame: 18 weeks). The study lists 4 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 14 Jun 2021.