Trial Outcomes & Findings for Exercise Effects on Word Learning (NCT NCT03370471)
NCT ID: NCT03370471
Last Updated: 2021-09-05
Results Overview
Study-specific word recall task comprising trained items. Participant is shown each trained item and types the name. Acquisition: immediately after exercise or stretching on Monday, Wednesday and Friday. Consolidation: immediately before exercise or stretching on Wednesday and Friday, one week after training (Friday)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Assessment occurs over a two-week period for each of the 4 intervention/arms: Week 1: Monday, Wednesday, Friday, Week 2: Friday
Results posted on
2021-09-05
Participant Flow
Participant milestones
| Measure |
Healthy Older Adults
Participants complete all four interventions
Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)
Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)
Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
|
Individuals With Aphasia
Participants complete all four interventions
Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)
Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)
Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
5
|
|
Overall Study
COMPLETED
|
16
|
3
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
Healthy Older Adults
Participants complete all four interventions
Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)
Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)
Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
|
Individuals With Aphasia
Participants complete all four interventions
Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)
Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)
Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
1
|
|
Overall Study
Unable to access veins for blood draw
|
0
|
1
|
|
Overall Study
Screen fail
|
1
|
0
|
Baseline Characteristics
Exercise Effects on Word Learning
Baseline characteristics by cohort
| Measure |
Healthy Older Adults
n=16 Participants
Participants complete all four study interventions
Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)
Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)
Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
|
Individuals With Aphasia
n=3 Participants
Participants complete all four study interventions
Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)
Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)
Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Age, Continuous
|
74.1 years
STANDARD_DEVIATION 5.1 • n=93 Participants
|
57.7 years
STANDARD_DEVIATION 21.1 • n=4 Participants
|
71.5 years
STANDARD_DEVIATION 10.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Assessment occurs over a two-week period for each of the 4 intervention/arms: Week 1: Monday, Wednesday, Friday, Week 2: FridayStudy-specific word recall task comprising trained items. Participant is shown each trained item and types the name. Acquisition: immediately after exercise or stretching on Monday, Wednesday and Friday. Consolidation: immediately before exercise or stretching on Wednesday and Friday, one week after training (Friday)
Outcome measures
| Measure |
Healthy Older Adults
n=16 Participants
Participants complete all four interventions
Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)
Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)
Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
|
Individuals With Aphasia
n=3 Participants
Participants complete all four interventions
Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)
Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)
Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
|
|---|---|---|
|
Study-Specific Word Recall Task
Acquisition- Retrieval Practice + Moderate Intensity Exercise
|
6.4 number of words gained
Standard Deviation 3.6
|
1.7 number of words gained
Standard Deviation 2.1
|
|
Study-Specific Word Recall Task
Consolidation- Retrieval Practice + Moderate Intensity Exercise
|
4.6 number of words gained
Standard Deviation 4.1
|
1.5 number of words gained
Standard Deviation 2.1
|
|
Study-Specific Word Recall Task
Acquisition- Retrieval Practice + Gentle Stretching
|
4.8 number of words gained
Standard Deviation 3.8
|
1.7 number of words gained
Standard Deviation 2.5
|
|
Study-Specific Word Recall Task
Consolidation- Retrieval Practice + Gentle Stretching
|
4.6 number of words gained
Standard Deviation 4.5
|
0.7 number of words gained
Standard Deviation 2.1
|
|
Study-Specific Word Recall Task
Acquisition- Study Only + Moderate Intensity Exercise
|
4.8 number of words gained
Standard Deviation 3.6
|
1.7 number of words gained
Standard Deviation 3.8
|
|
Study-Specific Word Recall Task
Consolidation- Study Only + Moderate Intensity Exercise
|
3.6 number of words gained
Standard Deviation 3.2
|
1.3 number of words gained
Standard Deviation 2.3
|
|
Study-Specific Word Recall Task
Acquisition- Study Only + Gentle Stretching
|
5.4 number of words gained
Standard Deviation 2.7
|
2.7 number of words gained
Standard Deviation 2.9
|
|
Study-Specific Word Recall Task
Consolidation- Study Only + Gentle Stretching
|
3.5 number of words gained
Standard Deviation 3.6
|
1.3 number of words gained
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Assessment occurs on Monday, Wednesday and Friday of Week 1 for each of the 4 intervention/armsBlood samples collected to measure serum BDNF concentration levels (pg/mL), as follows: 1. Before moderate intensity exercise or gentle stretching 2. Immediately after moderate intensity exercise or gentle stretching 3. Immediately after word learning 4. 15 minutes after word learning
Outcome measures
| Measure |
Healthy Older Adults
n=13 Participants
Participants complete all four interventions
Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)
Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)
Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
|
Individuals With Aphasia
n=2 Participants
Participants complete all four interventions
Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)
Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)
Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
|
|---|---|---|
|
Serum BDNF Concentration Levels (pg/mL)
Moderate Intensity Exercise- Before Exercise
|
195.50 serum BDNF concentration levels (pg/mL)
Standard Deviation 36.00
|
137.83 serum BDNF concentration levels (pg/mL)
Standard Deviation 51.88
|
|
Serum BDNF Concentration Levels (pg/mL)
Moderate Intensity Exercise- Immediately After Exercise
|
218.98 serum BDNF concentration levels (pg/mL)
Standard Deviation 79.39
|
156.01 serum BDNF concentration levels (pg/mL)
Standard Deviation 70.25
|
|
Serum BDNF Concentration Levels (pg/mL)
Moderate Intensity Exercise- Immediately After Learning
|
209.95 serum BDNF concentration levels (pg/mL)
Standard Deviation 75.70
|
153.70 serum BDNF concentration levels (pg/mL)
Standard Deviation 28.94
|
|
Serum BDNF Concentration Levels (pg/mL)
Moderate Intensity Exercise- 15 Minutes After Learning
|
204.17 serum BDNF concentration levels (pg/mL)
Standard Deviation 57.36
|
129.34 serum BDNF concentration levels (pg/mL)
Standard Deviation 12.90
|
|
Serum BDNF Concentration Levels (pg/mL)
Gentle Stretching- Before Stretching
|
199.92 serum BDNF concentration levels (pg/mL)
Standard Deviation 48.72
|
180.25 serum BDNF concentration levels (pg/mL)
Standard Deviation 42.48
|
|
Serum BDNF Concentration Levels (pg/mL)
Gentle Stretching- Immediately After Stretching
|
217.14 serum BDNF concentration levels (pg/mL)
Standard Deviation 49.33
|
201.19 serum BDNF concentration levels (pg/mL)
Standard Deviation 93.51
|
|
Serum BDNF Concentration Levels (pg/mL)
Gentle Stretching- Immediately After Learning
|
222.03 serum BDNF concentration levels (pg/mL)
Standard Deviation 58.78
|
140.85 serum BDNF concentration levels (pg/mL)
Standard Deviation 23.66
|
|
Serum BDNF Concentration Levels (pg/mL)
Gentle Stretching- 15 Minutes After Learning
|
218.00 serum BDNF concentration levels (pg/mL)
Standard Deviation 60.00
|
117.76 serum BDNF concentration levels (pg/mL)
Standard Deviation 40.87
|
SECONDARY outcome
Timeframe: Assessment occurs on Monday, Wednesday and Friday of Week 1 for each of the 4 intervention/armsPopulation: We were not able to obtain reliable measurements of dopamine for analysis.
The investigators will collect blood samples to detect changes in plasma dopamine in the training conditions on Monday and Friday sessions, as follows:. 1. Before exercise or stretching 2. Immediately after exercise or stretching 3. Immediately after word learning 4. 15 minutes after word learning
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: Assessment occurs over a two-week period for each of the 4 intervention/arms: Week 1: Monday, Wednesday, Friday, Week 2: FridayParticipants complete word recognition task on trained items. Acquisition: immediately after exercise or stretching on Monday, Wednesday, and Friday Consolidation: immediately before exercise or stretching on Monday and Wednesday, and one week after learning (Friday)
Outcome measures
| Measure |
Healthy Older Adults
n=16 Participants
Participants complete all four interventions
Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)
Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)
Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
|
Individuals With Aphasia
n=3 Participants
Participants complete all four interventions
Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)
Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)
Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
|
|---|---|---|
|
Word Recognition
Acquisition- Retrieval Practice + Moderate Intensity Exercise
|
3.1 number of words gained
Standard Deviation 2.3
|
4.0 number of words gained
Standard Deviation 1.7
|
|
Word Recognition
Consolidation- Retrieval Practice + Moderate Intensity Exercise
|
3.0 number of words gained
Standard Deviation 3.0
|
3.5 number of words gained
Standard Deviation .07
|
|
Word Recognition
Acquisition- Retrieval Practice + Gentle Stretching
|
3.1 number of words gained
Standard Deviation 2.0
|
3.0 number of words gained
Standard Deviation 3.5
|
|
Word Recognition
Consolidation- Retrieval Practice + Gentle Stretching
|
2.9 number of words gained
Standard Deviation 2.6
|
-1.7 number of words gained
Standard Deviation 1.5
|
|
Word Recognition
Acquisition- Study Only + Moderate Intensity Exercise
|
2.7 number of words gained
Standard Deviation 2.2
|
2.3 number of words gained
Standard Deviation 1.5
|
|
Word Recognition
Consolidation- Study Only + Moderate Intensity Exercise
|
1.8 number of words gained
Standard Deviation 2.4
|
0.3 number of words gained
Standard Deviation 2.1
|
|
Word Recognition
Acquisition- Study Only + Gentle Stretching
|
1.9 number of words gained
Standard Deviation 2.2
|
2.7 number of words gained
Standard Deviation 3.1
|
|
Word Recognition
Consolidation- Study Only + Gentle Stretching
|
3.2 number of words gained
Standard Deviation 2.8
|
1.7 number of words gained
Standard Deviation 0.5
|
Adverse Events
Healthy Older Adults
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Individuals With Aphasia
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Older Adults
n=23 participants at risk
Participants complete all four interventions
Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)
Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)
Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
|
Individuals With Aphasia
n=5 participants at risk
Participants complete all four interventions
Retrieval Practice + Moderate Intensity Exercise: Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)
Retrieval Practice + Gentle Stretching: Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)
Study Only + Moderate Intensity Exercise: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
Study Only + Gentle Stretching: Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
|
|---|---|---|
|
General disorders
Dizziness and Syncope
|
4.3%
1/23 • Number of events 1 • 3 months
|
0.00%
0/5 • 3 months
|
|
Injury, poisoning and procedural complications
Skin Burn
|
0.00%
0/23 • 3 months
|
20.0%
1/5 • Number of events 1 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place