Trial Outcomes & Findings for Aerobic Exercise and Cognitive Training in Older Adults (NCT NCT02787655)

Last Updated: 2020-11-16

Results Overview

The Category Verbal Fluency Test is demonstrated to be reliable and valid among adults aged 50 to 89. For Category Verbal Fluency, participants are asked to generate words from a category (e.g., colors) within 60 seconds. A higher change score represents better performance on the outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

78 participants

Primary outcome timeframe

change from pre and post separated by 12 weeks

Results posted on

2020-11-16

Participant Flow

Participant milestones

Participant milestones
Measure	Aerobic Exercise + Cognitive Training Group Exercise 3 times a week on a stationary ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes per session; plus 20 minutes of cognitive training using Mindfit program Aerobic exercise + Cognitive Training Group: stationary bicycling	Cognitive Training Only Group Cognitive Training Only Group. For this arm of the intervention, randomized participants followed the same guidelines as the cognitive component of the AE+CT group but did not partake in aerobic exercise. To equalize contact/monitoring of the groups this group met for the same total duration time as the AE+CT group; however, instead of aerobic exercise, progressive whole body stretching and toning exercises Cognitive training Only: 20 minutes of cognitive training using Mindfit program
Overall Study STARTED	40	38
Overall Study COMPLETED	29	26
Overall Study NOT COMPLETED	11	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aerobic Exercise and Cognitive Training in Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aerobic Exercise + Cognitive Training Group n=40 Participants Randomized participants attended exercise training sessions and cognitive training sessions	Cognitive Training Only Group n=38 Participants Participants will follow the same guidelines as the cognitive component of the AE+CT group but did not partake in aerobic exercise.	Total n=78 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	40 Participants n=5 Participants	38 Participants n=7 Participants	78 Participants n=5 Participants
Age, Continuous	69.7 years STANDARD_DEVIATION 6.34 • n=5 Participants	72.09 years STANDARD_DEVIATION 6.43 • n=7 Participants	71.24 years STANDARD_DEVIATION 6.39 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	40 Participants n=5 Participants	38 Participants n=7 Participants	78 Participants n=5 Participants

PRIMARY outcome

Timeframe: change from pre and post separated by 12 weeks

Outcome measures

Outcome measures
Measure	Aerobic Exercise + Cognitive Training Group n=29 Participants Exercise 3 times a week on a stationary ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes per session; plus 20 minutes of cognitive training using Mindfit program Aerobic exercise + Cognitive Training Group: stationary bicycling	Cognitive Training Only Group n=26 Participants Cognitive Training Only Group. For this arm of the intervention, randomized participants followed the same guidelines as the cognitive component of the AE+CT group but did not partake in aerobic exercise. To equalize contact/monitoring of the groups this group met for the same total duration time as the AE+CT group; however, instead of aerobic exercise, progressive whole body stretching and toning exercises Cognitive training Only: 20 minutes of cognitive training using Mindfit program
Change Executive Language Functions (Category Verbal Fluency)	5 Number of Fluent Words within 60 seconds Standard Deviation 2.5	-1 Number of Fluent Words within 60 seconds Standard Deviation 4

Adverse Events

Aerobic Exercise + Cognitive Training Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cognitive Training Only Group

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

Joe Nocera

Atl VA

Phone: 404 321 6111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place