Mild Cognitive ImpairmentCARBNCT02390453
Cognitive and Aerobic Resilience for the Brain
A study testing Combined Cognitive and Physical, Cognitive and Physical in people with Mild Cognitive Impairment, run by Indiana University at 1 site in United States.
Trial summary
This is a randomized controlled trial (RCT) of the effectiveness of cognitive and exercise training versus control condition on cognitive function in older adults with mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Combined Cognitive and Physical, Cognitive and Physical
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 25 Oct 2019
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- subjective memory complaint
- minimal impairment in daily function per Functional Activity Questionnaire (FAQ)
- sedentary
- English speaking
- access to telephone
Who cannot join
- dementia or Alzheimer disease
- stroke, past 12 months
- myocardial infarction, past 12 months
- angina
- Parkinson disease
- multiple sclerosis
Show all 29Show fewer
- epilepsy
- AIDS
- brain tumor, infection, or surgery
- brain injury with > 30 minute LOC
- schizophrenia
- bipolar disorder
- cancer with short life expectancy
- current chemotherapy or radiation therapy
- depression
- alcohol consumption ≥ 8 drinks per week for women, or ≥15 drinks per week for men
- prescription of Aricept or Namenda, past or present
- self-reported difficulty reading a newspaper (low visual acuity)
- low hearing or communicative ability (examiner-rated) that would interfere with interventions and outcome assessments
- prior involvement in similar cognitive training studies, programs, or online training
- prior use of online brain training or brain fitness programs
- unable to pass the Exercise Assessment and Screening for You (EASY)
- living in nursing home
- scheduling conflicts with intervention schedule
- unwilling to use a computer or be on video conferencing
- Baseline blood pressure of Systolic > 180
- Baseline blood pressure of Diastolic > 100
- Baseline pulse of < 40 or > 100
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized controlled trial (RCT) of the effectiveness of cognitive and exercise training versus control condition on cognitive function in older adults with mild cognitive impairment (MCI).
Read the detailed description
Exercise and cognitive training hold promise for delaying progression of MCI. Exercise improves cognitive ability, brain function, and brain structure in older adults. Cognitive training has been shown to durably improve mental abilities and functional status in older adults. In addition, persons with MCI respond to some forms of cognitive training just as robustly as healthy older adults.
This pilot study is a 4 group design with a home-based multi-modal physical exercise intervention, cognitive training, combined cognitive and physical training, and a social contact control enrolling older adults with MCI.
This pilot study is designed to be consistent with current recommended approaches to establishing trial feasibility. If the aims are achieved, it will provide a conceptual and practical rationale to support a large, multi-site, randomized clinical trial to test the efficacy of combined physical and cognitive training in delaying time to a clinical diagnosis of dementia.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Combined Cognitive and Physical, Cognitive, Physical, Active Control
- Keywords
- mild cognitive impairment, randomized controlled trial, cognitive training, exercise training, cognition, physical performance, disability, mood
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Cognitive and PhysicalBehavioural
Combined modules provide Cognitive training from Posit Science designed to improve information processing speed, learning, memory, and attention, and Physical training focused on seated aerobic and progressive resistance exercises designed to improve aerobic capacity, muscular strength, and endurance consistent with current exercise recommendations for older adults.
CognitiveBehavioural
Cognitive modules from Posit Science are designed to improve information processing speed, learning, memory, and attention.
PhysicalBehavioural
Physical modules are focused on seated aerobic and progressive resistance training designed to improve aerobic capacity, muscular strength, and endurance consistent with current exercise recommendations for older adults.
Active ControlBehavioural
Control modules provide social contact for group discussion of health and successful aging.
| Study group | Role | What they receive |
|---|---|---|
| Combined Cognitive and Physical | Experimental | This consists of 45 minutes of Cognitive arm + 45 minutes of Physical arm (90 minutes total), 3 days a week for 12 weeks (36 sessions). Receives: Behavioral: Combined Cognitive and Physical |
| Cognitive | Active comparator | This consists of 45 minutes of cognitive modules from Posit Science, 3 days a week for 12 weeks (36 sessions). Receives: Behavioral: Cognitive |
| Physical | Active comparator | This consists of 45 minutes of multi-modal physical exercise, 3 days a week for 12 weeks (36 sessions). Receives: Behavioral: Physical |
| Active Control | Active comparator | This consists of 45 minutes of group discussion of health and successful aging, 2 days a week for 12 weeks (24 sessions). Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function composite score as measured by individually-administered tests of psychomotor speed, complex sequencing, and list learning.
The cognitive composite is derived from: WAIS-IV Symbol Search, Trail Making Test Part B, and Rey Auditory Verbal Learning Test.
Measured: End of treatment at 12-weeks.
Average participant self-ratings of intervention acceptability.
Average of individual Likert self-ratings of the interventions (where 1 = very unenjoyable, 2 = not enjoyable, 3 = neutral, 4 = enjoyable, and 5 = very enjoyable) for each session of the 12-week intervention.
Measured: From date of randomization until the date of the final training session or the end of the 12-week intervention, whichever came first.
Participant adherence to treatment.
Number of training sessions attended divided by the the total number of sessions available.
Measured: From date of randomization until the date of the final training session or the end of the 12-week intervention, whichever came first.
Participant adherence to outcome assessment.
Number of participants completing the post-training outcome assessment divided by the total number randomized.
Measured: End of treatment at 12-weeks.
Number of participants with study-related adverse events (AE) by treatment arm.
Measured: From enrollment through end of treatment at 12-weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJan 2015
- Primary completion25 Oct 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Frederick Unverzagt, Indiana University
- Investigators
- Frederick W Unverzagt, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390453
- Sponsor's protocol ID
- R01AG045157
- Other IDs
- 1R01AG045157-01A1
- Acronym
- CARB
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2015
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Aerobic Resilience for the Brain
- ClinicalTrials.gov ID
- NCT02390453
- Acronym / sponsor ID
- CARB / R01AG045157
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment, randomized controlled trial, cognitive training, exercise training, cognition, physical performance, disability, mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jan 2015 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 17 Mar 2015 (estimated)
- 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.
This is a randomized controlled trial (RCT) of the effectiveness of cognitive and exercise training versus control condition on cognitive function in older adults with mild cognitive impairment (MCI).
Detailed description
Exercise and cognitive training hold promise for delaying progression of MCI. Exercise improves cognitive ability, brain function, and brain structure in older adults. Cognitive training has been shown to durably improve mental abilities and functional status in older adults. In addition, persons with MCI respond to some forms of cognitive training just as robustly as healthy older adults.
This pilot study is a 4 group design with a home-based multi-modal physical exercise intervention, cognitive training, combined cognitive and physical training, and a social contact control enrolling older adults with MCI.
This pilot study is designed to be consistent with current recommended approaches to establishing trial feasibility. If the aims are achieved, it will provide a conceptual and practical rationale to support a large, multi-site, randomized clinical trial to test the efficacy of combined physical and cognitive training in delaying time to a clinical diagnosis of dementia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Combined Cognitive and Physical | Experimental | Behavioral: Combined Cognitive and PhysicalThis consists of 45 minutes of Cognitive arm + 45 minutes of Physical arm (90 minutes total), 3 days a week for 12 weeks (36 sessions). |
| Cognitive | Active comparator | Behavioral: CognitiveThis consists of 45 minutes of cognitive modules from Posit Science, 3 days a week for 12 weeks (36 sessions). |
| Physical | Active comparator | Behavioral: PhysicalThis consists of 45 minutes of multi-modal physical exercise, 3 days a week for 12 weeks (36 sessions). |
| Active Control | Active comparator | Behavioral: Active ControlThis consists of 45 minutes of group discussion of health and successful aging, 2 days a week for 12 weeks (24 sessions). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- subjective memory complaint
- minimal impairment in daily function per Functional Activity Questionnaire (FAQ)
- sedentary
- English speaking
- access to telephone
Key exclusion criteria (29 listed)
- dementia or Alzheimer disease
- stroke, past 12 months
- myocardial infarction, past 12 months
- angina
- Parkinson disease
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 |
|---|---|---|
| Combined Cognitive and PhysicalCombined modules provide Cognitive training from Posit Science designed to improve information processing speed, learning, memory, and attention, and Physical training focused on seated aerobic and progressive resistance exercises designed to improve aerobic capacity, muscular strength, and endurance consistent with current exercise recommendations for older adults. | Behavioural | Combined Cognitive and Physical |
| CognitiveCognitive modules from Posit Science are designed to improve information processing speed, learning, memory, and attention. | Behavioural | Cognitive |
| PhysicalPhysical modules are focused on seated aerobic and progressive resistance training designed to improve aerobic capacity, muscular strength, and endurance consistent with current exercise recommendations for older adults. | Behavioural | Physical |
| Active ControlControl modules provide social contact for group discussion of health and successful aging. | Behavioural | Active Control |
Primary outcome
Cognitive function composite score as measured by individually-administered tests of psychomotor speed, complex sequencing, and list learning.
Time frame: End of treatment at 12-weeks.
The cognitive composite is derived from: WAIS-IV Symbol Search, Trail Making Test Part B, and Rey Auditory Verbal Learning Test.
Average participant self-ratings of intervention acceptability.
Time frame: From date of randomization until the date of the final training session or the end of the 12-week intervention, whichever came first.
Average of individual Likert self-ratings of the interventions (where 1 = very unenjoyable, 2 = not enjoyable, 3 = neutral, 4 = enjoyable, and 5 = very enjoyable) for each session of the 12-week intervention.
Participant adherence to treatment.
Time frame: From date of randomization until the date of the final training session or the end of the 12-week intervention, whichever came first.
Number of training sessions attended divided by the the total number of sessions available.
Participant adherence to outcome assessment.
Time frame: End of treatment at 12-weeks.
Number of participants completing the post-training outcome assessment divided by the total number randomized.
Number of participants with study-related adverse events (AE) by treatment arm.
Time frame: From enrollment through end of treatment at 12-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 7 Mar 2023.
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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.
Frederick W Unverzagt, PhD principal investigator
Indiana 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 Combined Cognitive and Physical, Cognitive and Physical in people with Mild Cognitive Impairment, run by Indiana 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 5 inclusion and 29 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 7 Mar 2023. 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?
Cognitive function composite score as measured by individually-administered tests of psychomotor speed, complex sequencing, and list learning. (time frame: End of treatment at 12-weeks.). 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 7 Mar 2023.