Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Behavioral: Combined Intervention; Behavioral: Walking Intervention; Behavioral: Cognitive Training Intervention

• Registration Number: NCT02864069
• Lead Sponsor: University of California, San Diego

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-11
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Results First Submitted: 2019-09-30
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-07
• Last Update Submitted: 2020-01-07
• Results First Posted: 2020-01-18
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined Intervention	Combined Intervention	-
Walking Intervention	Walking Intervention	-
Cognitive Training Intervention	Cognitive Training Intervention	-

Primary Outcome Measures

Name	Time	Method
Rivermead Behavioral Memory Test	12 weeks	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	12 weeks	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	12 weeks	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.

Trial Locations

Locations (1)

UCSD; 🇺🇸 La Jolla, California, United States