Trial Outcomes & Findings for Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI (NCT NCT02864069)

Last Updated: 2020-01-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

12 weeks

Results posted on

2020-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	Walking Intervention 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 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 Combined Intervention: The combined condition will concurrently follow both the walking and the CT programs as described above.
Overall Study STARTED	18	13	21
Overall Study COMPLETED	12	5	13
Overall Study NOT COMPLETED	6	8	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Walking Intervention n=18 Participants 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 n=13 Participants 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 n=21 Participants Combined Intervention: The combined condition will concurrently follow both the walking and the CT programs as described above.	Total n=52 Participants Total of all reporting groups
Age, Continuous	72.06 years STANDARD_DEVIATION 5.79 • n=5 Participants	64.0 years STANDARD_DEVIATION 4.06 • n=7 Participants	69.48 years STANDARD_DEVIATION 6.32 • n=5 Participants	69.0 years STANDARD_DEVIATION 6.37 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants	36 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	16 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants	50 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants	46 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Walking Intervention n=12 Participants 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 n=5 Participants 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 n=13 Participants Combined Intervention: The combined condition will concurrently follow both the walking and the CT programs as described above.
Rivermead Behavioral Memory Test	11.08 units on a scale Standard Deviation 3.8	11.2 units on a scale Standard Deviation 2.95	12.31 units on a scale Standard Deviation 1.93

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Walking Intervention n=9 Participants 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 n=4 Participants 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 n=13 Participants Combined Intervention: The combined condition will concurrently follow both the walking and the CT programs as described above.
Everyday Cognition Scale	1.50 units on a scale Standard Deviation .64	1.14 units on a scale Standard Deviation .17	1.24 units on a scale Standard Deviation .30

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Walking Intervention n=12 Participants 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 n=5 Participants 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 n=13 Participants Combined Intervention: The combined condition will concurrently follow both the walking and the CT programs as described above.
Older Peoples Quality of Life Questionnaire	76.08 units on a scale Standard Deviation 20.74	72.20 units on a scale Standard Deviation 7.46	68.15 units on a scale Standard Deviation 16.01

Adverse Events

Walking Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cognitive Training Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Combined Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amy Jak

UCSD

Phone: 8586423742

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place