Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI

Mild Cognitive Impairment Clinical Trial

— CBI  

Official title:

Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864069
• Other study ID #: NPSASA-14-321959
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: October 2018

Study information

• Verified date: January 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

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

Locations

Country	Name	City	State
United States	UCSD	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Alzheimer's Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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