An interventional study of Retrieval Practice + Moderate Intensity Exercise and Retrieval Practice + Gentle Stretching in Aging and Aphasia, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 35 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-05.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Other
The aging Veteran population will substantially increase over the next 10 years, as the 24.9% of Veterans who are currently between 55-64 years of age join the 38.5% who are already over age 65. The risk of stroke more than doubles each decade after age 55, which places Veterans at an ever-increasing risk of suffering stroke-related language impairment (i.e., aphasia). Difficulty retrieving words, which negatively impacts psychosocial well-being and quality of life, is the most common complaint in healthy aging and aphasia. Word retrieval interventions to maintain or restore communicative function are needed. Studies have shown that physical exercise can improve word learning in young adults. This study will investigate the effects of exercise on word learning in aging and aphasia. The results will help the us understand how exercise may be used to optimize word retrieval interventions for our aging Veterans.
Difficulty retrieving the right word to communicate a message is the most common complaint in healthy older adults and individuals with stroke-induced language impairment (i.e., aphasia). Novel word learning paradigms have been used to investigate a variety of behavioral and neuromodulatory approaches to improve word retrieval deficits. Previous novel word learning studies have shown that physical exercise can improve long term recall in healthy young adults and that increased levels of dopamine may be responsible for this effect; however, no studies have investigated the effects of exercise on novel word learning in older adults and individuals with aphasia, and very little is known about the mechanisms that support exercise-enhanced word learning in these populations.
The aims of this study are to:
This research will provide a platform for future investigations of immediate exercise effects on word learning, which are essential for achieving our long-term goal of developing exercise-based word retrieval interventions for healthy older Veterans and Veterans with aphasia.
A within subjects crossover design will be used to address Aims 1, 2a and 2b. Subjects will complete aerobic exercise or stretching (training) before engaging in Study Only or Retrieval Practice (learning). Subjects will be counterbalanced within and across conditions. Sixteen healthy older adults (65-89 years) and 16 individuals with aphasia (35-89 years), will be recruited. The study will comprise 18 sessions over 12 weeks. In Week 1, subjects will undergo baseline blood draws, a physical assessment, cognitive and language assessments, and a practice word learning task. In Weeks 2-12, subjects will complete the four conditions. Each condition will last two weeks, with a one-week break between conditions. In each condition, training and learning sessions will take place on Monday, Wednesday and Friday. Training: Subjects will engage in 30 minutes of moderate-intensity cycling or gentle upper and lower limb stretching (control) prior to engaging in a novel word learning task. Learning: Familiar objects (e.g., cup) will be paired with nonwords (e.g., flark). In the Study Only paradigm, object/nonword pairs will be presented three times across three days (Monday, Wednesday, Friday). In the Retrieval Practice paradigm, object/nonword pairs will be presented during the first session (Monday). In subsequent sessions (Wednesday, Friday), subjects will be asked to recall the nonword name of presented objects. Corrective feedback will be provided on each trial. Testing: Recognition and recall testing without corrective feedback will be administered immediately after learning (short-term memory), before training in the second and third learning session (overnight consolidation) and one week after learning (long-term memory). Blood Draws: Three blood samples will be taken at baseline (rest, 30 minutes, 60 minutes). In each of the four conditions, blood samples will be taking during the first and third learning session (at rest, after training, after learning, and 15 minutes after learning). Whole blood will be collected in plain tubes and in anticoagulant-treated tubes for subsequent serum BDNF and plasma dopamine analysis by ELISA. Samples will be analyzed in triplicate to increase reliability.
338 studies on the registry are indexed under Aphasia; 95 are open to participants now.
This study's enrollment of 28 is close to the median of 30 across 298 interventional studies indexed under Aphasia.
Browse Aphasia studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
use of hormone replacement therapy
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Behavioral: Retrieval Practice + Moderate Intensity Exercise · Behavioral: Retrieval Practice + Gentle Stretching · Behavioral: Study Only + Moderate Intensity Exercise · Behavioral: Study Only + Gentle Stretching
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)
Behavioral: Retrieval Practice + Moderate Intensity Exercise · Behavioral: Retrieval Practice + Gentle Stretching · Behavioral: Study Only + Moderate Intensity Exercise · Behavioral: Study Only + Gentle Stretching
Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)
Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)
Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
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
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)
Time frame: Assessment occurs over a two-week period for each of the 4 intervention/arms: Week 1: Monday, Wednesday, Friday, Week 2: Friday
Serum BDNF Concentration Levels (pg/mL)
Blood 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
Time frame: Assessment occurs on Monday, Wednesday and Friday of Week 1 for each of the 4 intervention/arms
Plasma Dopamine
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
Time frame: Assessment occurs on Monday, Wednesday and Friday of Week 1 for each of the 4 intervention/arms
| Milestone | Healthy Older Adults | Individuals With Aphasia |
|---|---|---|
| Started | 23 | 5 |
| Completed | 16 | 3 |
| Not completed | 7 | 2 |
| Withdrew: Withdrawal by subject | 6 | 1 |
| Withdrew: Unable to access veins for blood draw | 0 | 1 |
| Withdrew: Screen fail | 1 | 0 |
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)
| number of words gained | Healthy Older Adults | Individuals With Aphasia |
|---|---|---|
| Acquisition- Retrieval Practice + Moderate Intensity Exercise | 6.4 ± 3.6 | 1.7 ± 2.1 |
| Consolidation- Retrieval Practice + Moderate Intensity Exercise | 4.6 ± 4.1 | 1.5 ± 2.1 |
| Acquisition- Retrieval Practice + Gentle Stretching | 4.8 ± 3.8 | 1.7 ± 2.5 |
| Consolidation- Retrieval Practice + Gentle Stretching | 4.6 ± 4.5 | 0.7 ± 2.1 |
| Acquisition- Study Only + Moderate Intensity Exercise | 4.8 ± 3.6 | 1.7 ± 3.8 |
| Consolidation- Study Only + Moderate Intensity Exercise | 3.6 ± 3.2 | 1.3 ± 2.3 |
| Acquisition- Study Only + Gentle Stretching | 5.4 ± 2.7 | 2.7 ± 2.9 |
| Consolidation- Study Only + Gentle Stretching | 3.5 ± 3.6 | 1.3 ± 2.3 |
Blood 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
| serum BDNF concentration levels (pg/mL) | Healthy Older Adults | Individuals With Aphasia |
|---|---|---|
| Moderate Intensity Exercise- Before Exercise | 195.50 ± 36.00 | 137.83 ± 51.88 |
| Moderate Intensity Exercise- Immediately After Exercise | 218.98 ± 79.39 | 156.01 ± 70.25 |
| Moderate Intensity Exercise- Immediately After Learning | 209.95 ± 75.70 | 153.70 ± 28.94 |
| Moderate Intensity Exercise- 15 Minutes After Learning | 204.17 ± 57.36 | 129.34 ± 12.90 |
| Gentle Stretching- Before Stretching | 199.92 ± 48.72 | 180.25 ± 42.48 |
| Gentle Stretching- Immediately After Stretching | 217.14 ± 49.33 | 201.19 ± 93.51 |
| Gentle Stretching- Immediately After Learning | 222.03 ± 58.78 | 140.85 ± 23.66 |
| Gentle Stretching- 15 Minutes After Learning | 218.00 ± 60.00 | 117.76 ± 40.87 |
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
No measurements were reported for this outcome.
Participants 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)
| number of words gained | Healthy Older Adults | Individuals With Aphasia |
|---|---|---|
| Acquisition- Retrieval Practice + Moderate Intensity Exercise | 3.1 ± 2.3 | 4.0 ± 1.7 |
| Consolidation- Retrieval Practice + Moderate Intensity Exercise | 3.0 ± 3.0 | 3.5 ± .07 |
| Acquisition- Retrieval Practice + Gentle Stretching | 3.1 ± 2.0 | 3.0 ± 3.5 |
| Consolidation- Retrieval Practice + Gentle Stretching | 2.9 ± 2.6 | -1.7 ± 1.5 |
| Acquisition- Study Only + Moderate Intensity Exercise | 2.7 ± 2.2 | 2.3 ± 1.5 |
| Consolidation- Study Only + Moderate Intensity Exercise | 1.8 ± 2.4 | 0.3 ± 2.1 |
| Acquisition- Study Only + Gentle Stretching | 1.9 ± 2.2 | 2.7 ± 3.1 |
| Consolidation- Study Only + Gentle Stretching | 3.2 ± 2.8 | 1.7 ± 0.5 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Older Adults | 0/23 (0%) | 0/23 (0%) | 1/23 (4.3%) |
| Individuals With Aphasia | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) |
| Event | Healthy Older Adults | Individuals With Aphasia |
|---|---|---|
| Skin BurnInjury, poisoning and procedural complications | 0/23 | 1/5 |
| Dizziness and SyncopeGeneral disorders | 1/23 | 0/5 |
Number of participants who completed the study.
| Age, Continuous(years) | Healthy Older Adults | Individuals With Aphasia | Total |
|---|---|---|---|
| Mean | 74.1 ± 5.1 | 57.7 ± 21.1 | 71.5 ± 10.4 |
| Sex: Female, Male(Participants) | Healthy Older Adults | Individuals With Aphasia | Total |
|---|---|---|---|
| Female | 7 | 2 | 9 |
| Male | 9 | 1 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Healthy Older Adults | Individuals With Aphasia | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 16 | 3 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Healthy Older Adults | Individuals With Aphasia | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 1 | 5 |
| White | 11 | 2 | 13 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Healthy Older Adults | Individuals With Aphasia | Total |
|---|---|---|---|
| United States | 16 | 3 | 19 |
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