Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI

NCT ID: NCT02864069

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2018-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Walking Intervention

Group Type: EXPERIMENTAL

Walking Intervention

Intervention Type: 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.

Cognitive Training Intervention

Group Type: EXPERIMENTAL

Cognitive Training Intervention

Intervention Type: 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.

Combined Intervention

Group Type: EXPERIMENTAL

Combined Intervention

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Combined Intervention

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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alzheimer's Association

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Amy Jak

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Jak, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

UCSD

La Jolla, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NPSASA-14-321959

Identifier Type: -

Identifier Source: org_study_id