Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI

NCT02864069 | Completed Results

• 1 other identifier: NPSASA-14-321959
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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).

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Walking Intervention

EXPERIMENTAL

Behavioral: Walking Intervention

Cognitive Training Intervention

EXPERIMENTAL

Behavioral: Cognitive Training Intervention

Combined Intervention

EXPERIMENTAL

Behavioral: Combined Intervention

Interventions

Walking Intervention BEHAVIORAL

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.

Walking Intervention

Cognitive Training Intervention BEHAVIORAL

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.

Cognitive Training Intervention

Combined Intervention BEHAVIORAL

The combined condition will concurrently follow both the walking and the CT programs as described above.

Combined Intervention

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MCI diagnosis (can be self referral, will determine eligibility at baseline)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Diego: lead
• Alzheimer's Association: collaborator

Study Sites (1)

UCSD

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Amy Jak
• Organization: UCSD

ajak@ucsd.edu

8586423742

Study Officials

• Amy Jak, Ph.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: August 11, 2016
• Study Start: September 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 18, 2020
• Results First Posted: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)