Study Stopped
IRB Closure
Physical Exercise And Cognitive Engagement Outcomes for Mild Neurocognitive Disorder
PEACEOFMND
5 other identifiers
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2017
CompletedStudy Start
First participant enrolled
March 23, 2017
CompletedFirst Posted
Study publicly available on registry
March 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2022
CompletedJuly 6, 2022
June 1, 2022
5 years
March 23, 2017
June 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
baseline to 7.5 months
Secondary Outcomes (1)
Diffusion Tensor Imaging (DTI)
baseline to 7.5 Months
Other Outcomes (4)
improvement in patient memory based everyday functioning
baseline to 7.5 Months
improvement in patient and care partner quality of life
baseline to 7.5 Months
improvement in patient and carepartner mood
baseline to 7.5 Months
- +1 more other outcomes
Study Arms (3)
Computerized brain fitness training
EXPERIMENTALWill 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
EXPERIMENTALWill 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 COMPARATORWill receive a 10 day intervention program (over 2 weeks) consisting of Wellness Education, Calendar Training and Support Group.
Interventions
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.
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
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- 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.
- \. Physical impairments, language comprehension deficits, or significant hearing disturbances that would limit ability to perform tasks or participation in the intervention.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- Mayo Cliniccollaborator
- Tallahassee Memorial HealthCarecollaborator
- Florida Department of Healthcollaborator
Study Sites (1)
University of Florida
Gainesville, Florida, 32611, United States
Related Publications (1)
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.
PMID: 30340619DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Glenn Smith, Ph. D
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2017
First Posted
March 29, 2017
Study Start
March 23, 2017
Primary Completion
March 21, 2022
Study Completion
March 21, 2022
Last Updated
July 6, 2022
Record last verified: 2022-06