Trial Outcomes & Findings for Exercise Training to Improve Cognitive Function (NCT NCT03824639)

NCT ID: NCT03824639

Last Updated: 2024-02-14

Results Overview

Wechsler Logical Memory Task is a recall test involving 2 short stories. Possible scores on the delayed recall task range from 0 (no details recalled for both stories) to 50 (all details recalled on both stories). Outcome is change in the delayed recall score from baseline to 6 months.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

baseline and 6 months

Results posted on

2024-02-14

Participant Flow

Participant milestones

Participant milestones
Measure
Exercise Group
Structured exercise Structured exercise: Exercise instruction and encouragement
Control Group
Health education Health Education: Provision of general information about a variety of health topics
Overall Study
STARTED
29
31
Overall Study
COMPLETED
29
31
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exercise Training to Improve Cognitive Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Exercise Group
n=29 Participants
Structured exercise Structured exercise: Exercise instruction and encouragement
Control Group
n=31 Participants
Health education Health Education: Provision of general information about a variety of health topics
Total
n=60 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
n=99 Participants
4 Participants
n=107 Participants
8 Participants
n=206 Participants
Age, Categorical
>=65 years
25 Participants
n=99 Participants
27 Participants
n=107 Participants
52 Participants
n=206 Participants
Sex: Female, Male
Female
2 Participants
n=99 Participants
2 Participants
n=107 Participants
4 Participants
n=206 Participants
Sex: Female, Male
Male
27 Participants
n=99 Participants
29 Participants
n=107 Participants
56 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
29 Participants
n=99 Participants
31 Participants
n=107 Participants
60 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=99 Participants
1 Participants
n=107 Participants
4 Participants
n=206 Participants
Race (NIH/OMB)
White
26 Participants
n=99 Participants
30 Participants
n=107 Participants
56 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Wechsler Logical Memory Task
10.3 units on a scale
STANDARD_DEVIATION 5.6 • n=99 Participants
9.5 units on a scale
STANDARD_DEVIATION 7.1 • n=107 Participants
9.9 units on a scale
STANDARD_DEVIATION 6.4 • n=206 Participants
Rey-Osterrieth Complex Figure Test
9.0 units on a scale
STANDARD_DEVIATION 4.6 • n=99 Participants
7.6 units on a scale
STANDARD_DEVIATION 5.2 • n=107 Participants
8.3 units on a scale
STANDARD_DEVIATION 5.0 • n=206 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Wechsler Logical Memory Task is a recall test involving 2 short stories. Possible scores on the delayed recall task range from 0 (no details recalled for both stories) to 50 (all details recalled on both stories). Outcome is change in the delayed recall score from baseline to 6 months.

Outcome measures

Outcome measures
Measure
Exercise Group
n=29 Participants
Structured exercise Structured exercise: Exercise instruction and encouragement
Control Group
n=31 Participants
Health education Health Education: Provision of general information about a variety of health topics
Change in Delayed Recall Score on Wechsler Logical Memory Task From Baseline to 6 Months
0.74 units on a scale
Standard Deviation 4.0
-0.87 units on a scale
Standard Deviation 4.7

SECONDARY outcome

Timeframe: baseline and 6 months

Rey-Osterrieth Complex Figure Test is a recall test involving a complex figure. Possible scores on the delayed recall task range from 0 (no accurate details recalled for the figure) to 36 (all details accurately recalled for the figure). Outcome is change in the delayed recall score from baseline to 6 months.

Outcome measures

Outcome measures
Measure
Exercise Group
n=29 Participants
Structured exercise Structured exercise: Exercise instruction and encouragement
Control Group
n=31 Participants
Health education Health Education: Provision of general information about a variety of health topics
Change in Delayed Recall Score on the Rey-Osterrieth Complex Figure Test From Baseline to 6 Months
1.18 units on a scale
Standard Deviation 4.5
0.46 units on a scale
Standard Deviation 3.3

Adverse Events

Exercise 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. David Sparrow

VA Boston Healthcare System

Phone: 857-364-6400

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place