Trial Outcomes & Findings for Effects of Strengthening Exercise on the Brain for Early Dementia and Normative Older Adults (NCT NCT01264614)
NCT ID: NCT01264614
Last Updated: 2015-03-11
Results Overview
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Lower scores on Stroop C (possible range 0-240 sec) represents better performance).
COMPLETED
NA
22 participants
Baseline and 3 months
2015-03-11
Participant Flow
Early stage dementia participants were drawn from the Adult Day Care Program (ADCP) at a Veterans Affairs Medical Center (VAMC) in the northeast United States. Normative older adult participants were either employees or volunteers at the same facility recruited by fliers.
Participant milestones
| Measure |
Early Stage Dementia
Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
|
Normative Older Adults
Normative older adults with no known history of neurological condition.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
9
|
|
Overall Study
COMPLETED
|
12
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Strengthening Exercise on the Brain for Early Dementia and Normative Older Adults
Baseline characteristics by cohort
| Measure |
Early Stage Dementia
n=13 Participants
Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
|
Normative Older Adults
n=9 Participants
Normative older adults with no known history of neurological condition.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
79.3 years
n=5 Participants
|
62.8 years
n=7 Participants
|
71.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
9 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Education
|
11.5 years
n=5 Participants
|
11.6 years
n=7 Participants
|
11.6 years
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Lower scores on Stroop C (possible range 0-240 sec) represents better performance).
Outcome measures
| Measure |
Early Stage Dementia
n=12 Participants
Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
|
Normative Older Adults
n=7 Participants
Normative older adults with no known history of neurological condition.
|
|---|---|---|
|
Stroop Test Performance From Pre- to Post-intervention
Stroop C pre
|
137.67 Time to complete (seconds)
Standard Deviation 102.30
|
56.17 Time to complete (seconds)
Standard Deviation 10.34
|
|
Stroop Test Performance From Pre- to Post-intervention
Stroop C post
|
116.51 Time to complete (seconds)
Standard Deviation 64.44
|
55.13 Time to complete (seconds)
Standard Deviation 11.08
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Digits backwards possible score range is 0-14 points).
Outcome measures
| Measure |
Early Stage Dementia
n=12 Participants
Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
|
Normative Older Adults
n=7 Participants
Normative older adults with no known history of neurological condition.
|
|---|---|---|
|
Digits Backwards Test Performance From Pre- to Post-intervention
Digits Backward pre
|
4.10 Points
Standard Deviation 1.73
|
5.50 Points
Standard Deviation 2.59
|
|
Digits Backwards Test Performance From Pre- to Post-intervention
Digits Backward post
|
3.90 Points
Standard Deviation 1.10
|
6.83 Points
Standard Deviation 2.71
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Color Trails possible score range is 0-300 seconds).
Outcome measures
| Measure |
Early Stage Dementia
n=12 Participants
Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
|
Normative Older Adults
n=7 Participants
Normative older adults with no known history of neurological condition.
|
|---|---|---|
|
Color Trails Test Performance From Pre- to Post-intervention
Color Trails 2 pre
|
250.00 Time to complete (seconds)
Standard Deviation 186.45
|
124.00 Time to complete (seconds)
Standard Deviation 67.97
|
|
Color Trails Test Performance From Pre- to Post-intervention
Color Trails 2 post
|
259.01 Time to complete (seconds)
Standard Deviation 197.63
|
96.11 Time to complete (seconds)
Standard Deviation 19.97
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Fuld Semantic Recall possible score range is 0-20 points; Fuld Immediate and Delayed Recall possible score range is 0-10).
Outcome measures
| Measure |
Early Stage Dementia
n=12 Participants
Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
|
Normative Older Adults
n=7 Participants
Normative older adults with no known history of neurological condition.
|
|---|---|---|
|
Fuld Test Performance From Pre- to Post-intervention
Fuld Semantic Recall pre
|
10.60 Points
Standard Deviation 3.66
|
18.80 Points
Standard Deviation 8.76
|
|
Fuld Test Performance From Pre- to Post-intervention
Fuld Semantic Recall post
|
10.60 Points
Standard Deviation 4.27
|
18.60 Points
Standard Deviation 5.86
|
|
Fuld Test Performance From Pre- to Post-intervention
Fuld Immediate Recall pre
|
2.90 Points
Standard Deviation 2.38
|
6.60 Points
Standard Deviation 1.34
|
|
Fuld Test Performance From Pre- to Post-intervention
Fuld Immediate Recall post
|
4.40 Points
Standard Deviation 1.65
|
7.60 Points
Standard Deviation 1.52
|
|
Fuld Test Performance From Pre- to Post-intervention
Fuld Delayed Recall pre
|
2.60 Points
Standard Deviation 2.41
|
8.40 Points
Standard Deviation 1.14
|
|
Fuld Test Performance From Pre- to Post-intervention
Fuld Delayed Recall post
|
4.50 Points
Standard Deviation 2.72
|
8.20 Points
Standard Deviation .45
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Figure Copy \& Delayed possible score range is 0-36 points).
Outcome measures
| Measure |
Early Stage Dementia
n=12 Participants
Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
|
Normative Older Adults
n=7 Participants
Normative older adults with no known history of neurological condition.
|
|---|---|---|
|
Figure Copy & Delayed Test Performance From Pre- to Post-intervention
Figure Copy pre
|
16.44 Points
Standard Deviation 6.96
|
28.67 Points
Standard Deviation 3.99
|
|
Figure Copy & Delayed Test Performance From Pre- to Post-intervention
Figure Copy post
|
22.06 Points
Standard Deviation 9.96
|
30.33 Points
Standard Deviation 3.62
|
|
Figure Copy & Delayed Test Performance From Pre- to Post-intervention
Figure Delayed Recall pre
|
3.28 Points
Standard Deviation 4.41
|
14.50 Points
Standard Deviation 7.86
|
|
Figure Copy & Delayed Test Performance From Pre- to Post-intervention
Figure Delayed Recall post
|
7.81 Points
Standard Deviation 4.52
|
18.25 Points
Standard Deviation 3.25
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsResting EEG and ERP recordings before (T1) and after (T2) strengthening exercise intervention
Outcome measures
Outcome data not reported
Adverse Events
Early Stage Dementia
Normative Older Adults
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place