Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI (CBI)
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walking Intervention
Cognitive Training Intervention
Combined Intervention
Sponsored by
About this trial
This is an interventional health services research trial for Mild Cognitive Impairment
Eligibility Criteria
Inclusion Criteria:
- MCI diagnosis (can be self referral, will determine eligibility at baseline)
Exclusion Criteria:
- Dementia diagnosis
- Head trauma
- Neuro/psychiatric disorders
- Current substance dependence
- Sensory/mobility deficits
- No more than 1 hour of purposeful, aerobic activity/week
- Currently engaging in any other brain-stimulating computer program (No more than 1 hour a week)
Sites / Locations
- UCSD
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Walking Intervention
Cognitive Training Intervention
Combined Intervention
Arm Description
Outcomes
Primary Outcome Measures
Rivermead Behavioral Memory Test
The Rivermead Behavioral Memory Test (RBMT) is an ecologically valid assessment of cognitive functioning that tests some skills specifically trained in the CT condition (e.g., name learning, and story learning) but also additional untrained skills such as prospective memory. Belongings subtest scaled scores: Minimum score = 1, Maximum score = 19; higher values represent better performance.
Everyday Cognition Scale
The Everyday Cognition Scale (ECog) assesses (via informant report) everyday cognitive functioning in memory, language, visuospatial, and executive functioning domains. Average total score was used: Minimum = 1, Maximum = 4, higher scores indicate greater impairment
Older Peoples Quality of Life Questionnaire
Self report assessment of quality of life specific to older adults. Assessment covers life overall, health, social relationships and participation, independence, control over life and freedom, home and neighborhood, psychological and emotional well-being, financial circumstances, leisure/activities, and culture and religion. Total score minimum = 35, max = 175; lower scores indicate better quality of life.
Secondary Outcome Measures
Full Information
NCT ID
NCT02864069
First Posted
June 27, 2016
Last Updated
January 7, 2020
Sponsor
University of California, San Diego
Collaborators
Alzheimer's Association
1. Study Identification
Unique Protocol Identification Number
NCT02864069
Brief Title
Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI
Acronym
CBI
Official Title
Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Alzheimer's Association
4. Oversight
5. Study Description
Brief Summary
Vast evidence supports use of physical exercise and cognitive stimulation for lowering risk for cognitive decline and dementia, with combinations of non-pharmacological interventions providing greatest promise for impacting cognitive aging. This, paired with limited cognitive benefits from pharmacological interventions in dementia, has shifted focus to non-pharmacological interventions administered earlier in the disease course. This application, therefore, proposes a randomized controlled trial (RCT; 12-week active intervention, 3- and 6-month follow-up) comparing 3 conditions: walking program (guided progressive increases in weekly step counts), computer-based cognitive training program (Brain HQ, Posit Science), and combination of the exercise and cognitive program, on cognitive, functional, and diagnostic outcomes in 60 sedentary, community-dwelling adults with mild cognitive impairment (MCI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Walking Intervention
Arm Type
Experimental
Arm Title
Cognitive Training Intervention
Arm Type
Experimental
Arm Title
Combined Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Walking Intervention
Intervention Description
The walking intervention will begin following baseline assessments and will be continued for 12 weeks. Participants will be given a pedometer to use daily and log their daily steps, with an identified goal of increasing step counts by 3000 steps a day over the course of the intervention. After obtaining a week long baseline step count, individuals in the intervention group will progressively increase their step counts by 100 steps daily each week for the first three weeks, by 200 steps daily for weeks four through six, by 300 steps daily for weeks seven through nine, and by 400 steps daily for weeks ten through twelve. Mean baseline step counts for sedentary older adults in our pilot work were 4150 per day; therefore, most participants will almost double their daily activity by the end of the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training Intervention
Intervention Description
In the CT condition, participants will use Brain HQ, a computer cognitive training program (Posit Science Corporation, San Francisco, CA), shown to be well tolerated by older adults with positive short- and long-term cognitive outcomes. Participants will use the program 60 minutes/day, 5 days/week for 12 weeks. If participants do not have a home computer/internet access, they can complete the modules at another location such as a public library, senior center, or at the MARC, but training will still be self-directed.
Intervention Type
Behavioral
Intervention Name(s)
Combined Intervention
Intervention Description
The combined condition will concurrently follow both the walking and the CT programs as described above.
Primary Outcome Measure Information:
Title
Rivermead Behavioral Memory Test
Description
The Rivermead Behavioral Memory Test (RBMT) is an ecologically valid assessment of cognitive functioning that tests some skills specifically trained in the CT condition (e.g., name learning, and story learning) but also additional untrained skills such as prospective memory. Belongings subtest scaled scores: Minimum score = 1, Maximum score = 19; higher values represent better performance.
Time Frame
12 weeks
Title
Everyday Cognition Scale
Description
The Everyday Cognition Scale (ECog) assesses (via informant report) everyday cognitive functioning in memory, language, visuospatial, and executive functioning domains. Average total score was used: Minimum = 1, Maximum = 4, higher scores indicate greater impairment
Time Frame
12 weeks
Title
Older Peoples Quality of Life Questionnaire
Description
Self report assessment of quality of life specific to older adults. Assessment covers life overall, health, social relationships and participation, independence, control over life and freedom, home and neighborhood, psychological and emotional well-being, financial circumstances, leisure/activities, and culture and religion. Total score minimum = 35, max = 175; lower scores indicate better quality of life.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
MCI diagnosis (can be self referral, will determine eligibility at baseline)
Exclusion Criteria:
Dementia diagnosis
Head trauma
Neuro/psychiatric disorders
Current substance dependence
Sensory/mobility deficits
No more than 1 hour of purposeful, aerobic activity/week
Currently engaging in any other brain-stimulating computer program (No more than 1 hour a week)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Jak, Ph.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI
We'll reach out to this number within 24 hrs