Back to resultsPhysical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder (PEACEOFMND)
Primary Purpose
Mild Cognitive Impairment, Memory Disorders, Mild Dementia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized brain fitness training
Yoga
Wellness Education
Support Group (patient and partner)
Cognitive Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment
Eligibility Criteria
For the patients diagnosed with MCI:
Inclusion Criteria:
- 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.
- A score of at least 25 on the Telephone Interview for Cognitive Status for Memory.
Exclusion Criteria:
- 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:
Inclusion Criteria:
- 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.
Exclusion Criteria:
1. Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks or participation in the intervention.
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Computerized brain fitness training
Yoga
Wellness Education
Arm Description
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.
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.
Will receive a 10 day intervention program (over 2 weeks) consisting of Wellness Education, Calendar Training and Support Group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Diffusion Tensor Imaging (DTI)
DTI will be used to map white matter tractography in the brain.
Full Information
NCT ID
NCT03095170
First Posted
March 23, 2017
Last Updated
June 30, 2022
Sponsor
University of Florida
Collaborators
Mayo Clinic, Tallahassee Memorial HealthCare, Florida Department of Health
1. Study Identification
Unique Protocol Identification Number
NCT03095170
Brief Title
Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder
Acronym
PEACEOFMND
Official Title
Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
IRB Closure
Study Start Date
March 23, 2017 (Actual)
Primary Completion Date
March 21, 2022 (Actual)
Study Completion Date
March 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Mayo Clinic, Tallahassee Memorial HealthCare, Florida Department of Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Memory Disorders, Mild Dementia, Impaired Cognition, Mild Cognitive Disorder, Amnestic Disorder, Dementia and Amnestic Conditions, Poor Short-term Memory, Memory Impairment, Mild Neurocognitive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computerized brain fitness training
Arm Type
Experimental
Arm Description
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.
Arm Title
Yoga
Arm Type
Experimental
Arm Description
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.
Arm Title
Wellness Education
Arm Type
Active Comparator
Arm Description
Will receive a 10 day intervention program (over 2 weeks) consisting of Wellness Education, Calendar Training and Support Group.
Intervention Type
Behavioral
Intervention Name(s)
Computerized brain fitness training
Other Intervention Name(s)
Brain Fitness
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Wellness Education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Support Group (patient and partner)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Rehabilitation
Other Intervention Name(s)
Memory Compensation Training, Memory Support System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Resting State Magnetic Resonance Imaging (MRI)
Description
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.
Time Frame
baseline to 7.5 months
Secondary Outcome Measure Information:
Title
Diffusion Tensor Imaging (DTI)
Description
DTI will be used to map white matter tractography in the brain.
Time Frame
baseline to 7.5 Months
Other Pre-specified Outcome Measures:
Title
improvement in patient memory based everyday functioning
Description
measured by the Everyday Cognitive Functioning scale (ECOG)
Time Frame
baseline to 7.5 Months
Title
improvement in patient and care partner quality of life
Description
measured by the quality of life measured by the Quality of Life in Alzheimer's Disease scale (QOL-AD)
Time Frame
baseline to 7.5 Months
Title
improvement in patient and carepartner mood
Description
measured by the Center for Epidemiological Studies-Depression (CESD)
Time Frame
baseline to 7.5 Months
Title
improvement in patient cognitive functioning
Description
measured by the CogState
Time Frame
baseline to 7.5 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For the patients diagnosed with MCI:
Inclusion Criteria:
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.
A score of at least 25 on the Telephone Interview for Cognitive Status for Memory.
Exclusion Criteria:
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:
Inclusion Criteria:
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.
Exclusion Criteria:
1. Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks or participation in the intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn Smith, Ph. D
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30340619
Citation
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.
Results Reference
derived
Learn more about this trial
Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder
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