Mild Cognitive ImpairmentPEACEOFMNDNCT03095170
Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder
A study testing Computerized brain fitness training, Yoga and Wellness Education in people with Mild Cognitive Impairment and Memory Disorders, run by University of Florida at 1 site in United States.
Trial summary
Behavioral interventions currently provide the most useful approach to addressing the behavioral and social needs of those with Mild Cognitive Impairment (MCI) due to Alzheimer's or other diseases. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Memory Disorders, Mild Dementia
- What is being tested?
- Computerized brain fitness training, Yoga and Wellness Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2017to 21 Mar 2022
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent for participation. Patient also needs to sign a legally authorized representative (LAR) addendum should MCI patient become incapacitated
- A diagnosis of amnestic MCI (single domain or multi-domain)
- A Clinical Dementia Rating scale score of 0 or 0.5
- At least 50.
- Either not taking or stable on nootropic(s) and/or pain medication for at least 3 months.
- Fluent in English.
Show all 11Show fewer
- A score of at least 25 on the Telephone Interview for Cognitive Status for Memory.
- Written informed consent for participation.
- At least 21 years of age.
- A score of at least 32 on the Telephone Interview for Cognitive Status for Memory.
- Partner has at least twice-weekly contact with the participant.
Who cannot join
- MRI contraindications (e.g., ferrous metal in the body, claustrophobia, pregnancy)
- Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks or participation in the intervention.
- For the care partners:
- 1. Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks or participation in the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Behavioral interventions currently provide the most useful approach to addressing the behavioral and social needs of those with Mild Cognitive Impairment (MCI) due to Alzheimer's or other diseases. This randomized, multisite, 3-arm study will investigate the impact of computerized brain fitness vs yoga vs an active control group (wellness education) on changes in cognitive function, daily functioning and quality of life in persons with Mild Cognitive Impairment (MCI) and their partner. In addition, in vivo neuroimaging measures of plasticity during the pre- and post-intervention periods will be measured and compared between the three different treatment groups. These neuroimaging measures of plasticity will be investigated in their relationship to the cognitive outcomes within each group.
- Conditions
- Mild Cognitive Impairment, Memory Disorders, Mild Dementia, Impaired Cognition, Mild Cognitive Disorder, Amnestic Disorder
- Being tested
- Computerized brain fitness training, Yoga, Wellness Education, Support Group (patient and partner), Cognitive Rehabilitation
- Medical subject headings
- Cognitive Dysfunction, Memory Disorders, Cognition Disorders, Neurocognitive Disorders, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized brain fitness trainingBehavioural
Also called Brain Fitness
Will use the commercially available Posit Science product BrainHQ™ (www.brainhq.com) on tablets (e.g. iPads). Participants will complete 45-60 minutes of training daily in the program.
YogaBehavioural
Will use adapted Hatha Yoga where participants sit on armless chairs placed on sticky mats for some asana (poses) and use the chair for support throughout. This adapted Hatha Yoga style is appropriate for older adults including those who have limited mobility, use walkers or are in wheelchairs. The appropriately sequenced yoga practice meets the American College of Sports Medicine recommendation for older adults for muscle strengthening and flexibility. Instructions are modeled for the participants
Wellness EducationBehavioural
The education component will involve daily 60-minute group sessions with topics such as Introduction to the Program, Living with MCI, Changes in Roles, Communication and Relationships, Sleep Hygiene, Steps to Healthy Brain Aging, Preventing Dementia, MCI and Depression, Nutrition, Safety and Assistive Technologies, and Participating in Research, Community Resources, Meaning and Purpose, and Joy.
Support Group (patient and partner)Behavioural
Journal© as a basis for reminiscence-focused group sessions. Partner: The care partner support group meets separately from the patient group for 45-60 minutes daily.
Cognitive RehabilitationBehavioural
Also called Memory Compensation Training, Memory Support System
Will provide each couple with memory compensation training 5 days per week for 2 weeks, with initial and ending adherence sessions. All sessions will involve 45- 60 minutes of training. The curriculum is described briefly here.
Learning phases. three training stages from learning theory: 1) an acquisition phase in which use of the memory compensation system is learned, 2) an application phase in which a participant is taught to apply to his/her daily life, and 3) an adaptation phase in which a participant practices incorporating into his/her daily life so as to make its use habitual.
| Study group | Role | What they receive |
|---|---|---|
| Computerized brain fitness training | Experimental | Will receive a 10 day intervention program (over 2 weeks) consisting of Computer Brain Fitness Training, Calendar Training and Support Group.
After the initial two week intervention, there will be an extended period during which participants will continue the computerized brain fitness for another 24 weeks.Participants are encouraged to do at least two hours per week. Receives: Behavioral: Computerized brain fitness training; Behavioral: Support Group (patient and partner); Behavioral: Cognitive Rehabilitation |
| Yoga | Experimental | Will receive a 10 day intervention program (over 2 weeks) consisting of Yoga, Calendar Training, and Support Group.
After the initial two week intervention, there will be an extended period during which participants will continue yoga for 24 weeks. Participants assigned to the yoga intervention will continue to meet with their group and their yoga instructor for one hour per week and will be expected to do at least an additional hour of yoga by themselves every week. Receives: Behavioral: Yoga; Behavioral: Support Group (patient and partner); Behavioral: Cognitive Rehabilitation |
| Wellness Education | Active comparator | Will receive a 10 day intervention program (over 2 weeks) consisting of Wellness Education, Calendar Training and Support Group. Receives: Behavioral: Wellness Education; Behavioral: Support Group (patient and partner); Behavioral: Cognitive Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting State Magnetic Resonance Imaging (MRI)
Resting State MRI will allow us to investigate the functional connectivity in the brain, by looking at resting state networks such as the Default Mode Network.
Measured: baseline to 7.5 months
Secondary outcomes (1)
Diffusion Tensor Imaging (DTI)
DTI will be used to map white matter tractography in the brain.
Measured: baseline to 7.5 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start23 Mar 2017
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
Why it stopped: IRB Closure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Tallahassee Memorial HealthCare, Florida Department of Health
- Responsible party
- Sponsor
- Investigators
- Glenn Smith, Ph. D, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095170
- Sponsor's protocol ID
- IRB201700004
- Other IDs
- 7AZA1, 9AZ15, IRB201900522, OCR21041
- Acronym
- PEACEOFMND
- Status last verified
- Jun 2022
- First submitted
- 23 Mar 2017
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De Wit L, O'Shea D, Chandler M, Bhaskar T, Tanner J, Vemuri P, Crook J, Morris M, Smith G. Physical exercise and cognitive engagement outcomes for mild neurocognitive disorder: a group-randomized pilot trial. Trials. 2018 Oct 19;19(1):573. doi: 10.1186/s13063-018-2865-3.
PubMed 30340619
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder
- ClinicalTrials.gov ID
- NCT03095170
- Acronym / sponsor ID
- PEACEOFMND / IRB201700004
- Conditions
- Mild Cognitive Impairment, Memory Disorders, Mild Dementia, Impaired Cognition, Mild Cognitive Disorder, Amnestic Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB Closure
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Mayo Clinic, Tallahassee Memorial HealthCare, Florida Department of Health
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 29 Mar 2017 (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.
Behavioral interventions currently provide the most useful approach to addressing the behavioral and social needs of those with Mild Cognitive Impairment (MCI) due to Alzheimer's or other diseases. This randomized, multisite, 3-arm study will investigate the impact of computerized brain fitness vs yoga vs an active control group (wellness education) on changes in cognitive function, daily functioning and quality of life in persons with Mild Cognitive Impairment (MCI) and their partner. In addition, in vivo neuroimaging measures of plasticity during the pre- and post-intervention periods will be measured and compared between the three different treatment groups. These neuroimaging measures of plasticity will be investigated in their relationship to the cognitive outcomes within each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Computerized brain fitness training | Experimental | Behavioral: Computerized brain fitness training, Behavioral: Support Group (patient and partner), Behavioral: Cognitive RehabilitationWill receive a 10 day intervention program (over 2 weeks) consisting of Computer Brain Fitness Training, Calendar Training and Support Group. After the initial two week intervention, there will be an extended period during which participants will continue the computerized brain fitness for another 24 weeks.Participants are encouraged to do at least two hours per week. |
| Yoga | Experimental | Behavioral: Yoga, Behavioral: Support Group (patient and partner), Behavioral: Cognitive RehabilitationWill receive a 10 day intervention program (over 2 weeks) consisting of Yoga, Calendar Training, and Support Group. After the initial two week intervention, there will be an extended period during which participants will continue yoga for 24 weeks. Participants assigned to the yoga intervention will continue to meet with their group and their yoga instructor for one hour per week and will be expected to do at least an additional hour of yoga by themselves every week. |
| Wellness Education | Active comparator | Behavioral: Wellness Education, Behavioral: Support Group (patient and partner), Behavioral: Cognitive RehabilitationWill receive a 10 day intervention program (over 2 weeks) consisting of Wellness Education, Calendar Training and Support Group. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent for participation. Patient also needs to sign a legally authorized representative (LAR) addendum should MCI patient become incapacitated
- A diagnosis of amnestic MCI (single domain or multi-domain)
- A Clinical Dementia Rating scale score of 0 or 0.5
- At least 50.
- Either not taking or stable on nootropic(s) and/or pain medication for at least 3 months.
Key exclusion criteria (4 listed)
- MRI contraindications (e.g., ferrous metal in the body, claustrophobia, pregnancy)
- Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks or participation in the intervention.
- 1. Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks or participation in the intervention.
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 |
|---|---|---|
| Computerized brain fitness trainingAlso: Brain FitnessWill use the commercially available Posit Science product BrainHQ™ (www.brainhq.com) on tablets (e.g. iPads). Participants will complete 45-60 minutes of training daily in the program. | Behavioural | Computerized brain fitness training |
| YogaWill use adapted Hatha Yoga where participants sit on armless chairs placed on sticky mats for some asana (poses) and use the chair for support throughout. This adapted Hatha Yoga style is appropriate for older adults including those who have limited mobility, use walkers or are in wheelchairs. The appropriately sequenced yoga practice meets the American College of Sports Medicine recommendation for older adults for muscle strengthening and flexibility. Instructions are modeled for the participants | Behavioural | Yoga |
| Wellness EducationThe education component will involve daily 60-minute group sessions with topics such as Introduction to the Program, Living with MCI, Changes in Roles, Communication and Relationships, Sleep Hygiene, Steps to Healthy Brain Aging, Preventing Dementia, MCI and Depression, Nutrition, Safety and Assistive Technologies, and Participating in Research, Community Resources, Meaning and Purpose, and Joy. | Behavioural | Wellness Education |
| Support Group (patient and partner)Journal© as a basis for reminiscence-focused group sessions. Partner: The care partner support group meets separately from the patient group for 45-60 minutes daily. | Behavioural | Computerized brain fitness training, Wellness Education, Yoga |
| Cognitive RehabilitationAlso: Memory Compensation Training, Memory Support SystemWill provide each couple with memory compensation training 5 days per week for 2 weeks, with initial and ending adherence sessions. All sessions will involve 45- 60 minutes of training. The curriculum is described briefly here. Learning phases. three training stages from learning theory: 1) an acquisition phase in which use of the memory compensation system is learned, 2) an application phase in which a participant is taught to apply to his/her daily life, and 3) an adaptation phase in which a participant practices incorporating into his/her daily life so as to make its use habitual. | Behavioural | Computerized brain fitness training, Wellness Education, Yoga |
Primary outcome
Resting State Magnetic Resonance Imaging (MRI)
Time frame: baseline to 7.5 months
Resting State MRI will allow us to investigate the functional connectivity in the brain, by looking at resting state networks such as the Default Mode Network.
1 secondary outcome
Diffusion Tensor Imaging (DTI)
Time frame: baseline to 7.5 Months
Results and safety
The study was stopped early (reason given: IRB Closure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Derived from this study: PubMed 30340619De Wit L, O'Shea D, Chandler M, Bhaskar T, Tanner J, Vemuri P, Crook J, Morris M, Smith G. Physical exercise and cognitive engagement outcomes for mild neurocognitive disorder: a group-randomized pilot trial. Trials. 2018 Oct 19;19(1):573. doi: 10.1186/s13063-018-2865-3.
- Individual participant dataSharing planned: Undecided
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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.
Glenn Smith, Ph. D principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized brain fitness training, Yoga and Wellness Education in people with Mild Cognitive Impairment and Memory Disorders, 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 11 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: stopped early, as of the sponsor's last update on 6 Jul 2022. 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 was stopped early (reason given: IRB Closure). Results are not available in the source record.
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?
Resting State Magnetic Resonance Imaging (MRI) (time frame: baseline to 7.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03095170, which also lists 1 linked publication.
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 6 Jul 2022.