Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI (CBI)

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).

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Walking Intervention; Behavioral: Cognitive Training Intervention; Behavioral: Combined Intervention

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • UCSD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Walking Intervention	Behavioral: Walking Intervention; 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.
Experimental: Cognitive Training Intervention	Behavioral: Cognitive Training Intervention; 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.
Experimental: Combined Intervention	Behavioral: Combined Intervention; The combined condition will concurrently follow both the walking and the CT programs as described above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks
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	12 weeks
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.	12 weeks

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Alzheimer's Association
• Investigators: Principal Investigator: Amy Jak, Ph.D., University of California, San Diego

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 11, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: NPSASA-14-321959

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES