Trial Outcomes & Findings for Aerobic Exercise to Improve Executive Language Function In Older Adults (NCT NCT00979069)

Last Updated: 2014-11-26

Results Overview

The Verbal Fluency Test is demonstrated to be reliable and valid among adults aged 50 to 89 (Delis, et al., 2001; Delis, Kramer, Kaplan, \& Hodnack, 2004). The Verbal Fluency Test has three conditions, Letter Verbal Fluency, Category Verbal Fluency, and Switching Verbal Fluency. Each was randomized at pre- and post-12 week timeline and equated for difficulty. Letter Verbal Fluency assesses the number of words beginning with certain letters that participants can generate within 60 seconds,the Category Verbal Fluency assesses the number of words within particular categories participants can generate within 60 seconds, and the Switching Verbal Fluency assesses the number of words while alternating between different categories participants can generate within 60 seconds. For each condition (letter, category, and switching) a total score representing the total number of correct

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

number of correct words at pre and post separated by 12 weeks

Results posted on

2014-11-26

Participant Flow

Participant milestones

Participant milestones
Measure	Aerobic Group 12 weeks of aerobic exercise 3 times a week Aerobic group: 12 weeks of aerobic exercise 3 times a week	Control Group No contact control
Overall Study STARTED	10	10
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aerobic Exercise to Improve Executive Language Function In Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aerobic Group n=10 Participants 12 weeks of aerobic exercise 3 times a week Aerobic group: 12 weeks of aerobic exercise 3 times a week	Control Group n=8 Participants No contact control	Total n=18 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	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 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	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	8 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: number of correct words at pre and post separated by 12 weeks

Outcome measures

Outcome measures
Measure	Aerobic Group n=10 Participants 12 weeks of aerobic exercise 3 times a week Aerobic group: 12 weeks of aerobic exercise 3 times a week	Control Group n=8 Participants No contact control
Executive Language Functions Letter Verbal Fluency- Pre	31.6 Mean outpoint by group at pre and post Standard Deviation 6.0	30.8 Mean outpoint by group at pre and post Standard Deviation 3.6
Executive Language Functions Letter Verbal Fluency- Post	33.7 Mean outpoint by group at pre and post Standard Deviation 6.0	31.8 Mean outpoint by group at pre and post Standard Deviation 2.6
Executive Language Functions Category Verbal Fluency- Pre	39 Mean outpoint by group at pre and post Standard Deviation 5.4	40.2 Mean outpoint by group at pre and post Standard Deviation 3.9
Executive Language Functions Category Verbal Fluency- Post	45.1 Mean outpoint by group at pre and post Standard Deviation 8.1	41 Mean outpoint by group at pre and post Standard Deviation 4.4
Executive Language Functions Switching Verbal Fluency- Pre	10.6 Mean outpoint by group at pre and post Standard Deviation 2.5	11.4 Mean outpoint by group at pre and post Standard Deviation 1.7
Executive Language Functions Switching Verbal Fluency- Post	13.1 Mean outpoint by group at pre and post Standard Deviation 1.7	12.8 Mean outpoint by group at pre and post Standard Deviation 2.5

Adverse Events

Aerobic Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control 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

Dr. Joe Nocera

Atlanta VAMC

Phone: 404 321 6111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place