AgingNCT03370471
Exercise Effects on Word Learning
A study testing Retrieval Practice + Moderate Intensity Exercise, Retrieval Practice + Gentle Stretching and Study Only + Moderate Intensity Exercise in people with Aging and Aphasia, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 89 yearsHealthy volunteers can take part
- What is being tested?
- Retrieval Practice + Moderate Intensity Exercise, Retrieval Practice + Gentle Stretching and Study Only + Moderate Intensity Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2016to 16 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- monolingual English speakers
- "low physical activity" on the International Physical Activity Questionnaire
- physician's written approval for participation in moderate-intensity exercise
Who cannot join
- VO2 max >26 (men) and 22 (women)
- inability to cycle for 3 minutes at 50 revolutions/minute with no resistance
- any comorbid condition with exercise contraindications
- use of hormone replacement therapy
- dopaminergic
- anti-depressant
Show all 14Show fewer
- anti-psychotic
- or illicit drugs
- consumption of >14 alcoholic drinks/week or > 1pack of cigarettes/day
- uncorrected hearing or vision impairments that interfere with study procedures
- inability to read or repeat nonwords (e.g., flark)
- inability to learn one novel word during a practice learning task
- below cut-off on the Montreal Cognitive Assessment or the Comprehensive Aphasia Test Cognitive Screen
- and/or >10 on the Beck Depression Inventory
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
About this study
Official title: Acute Exercise Effects on Word Learning in Aging and Stroke-induced Aphasia
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.
Read the detailed description
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:
- to identify the novel word learning paradigm that facilitates immediate and long-term word recall 2a) to investigate how acute, moderate-intensity exercise alters levels of serum brain-derived neurotrophic factor (BDNF) and plasma dopamine 2b) to describe and quantify the association between novel word learning and any observed changes in serum BDNF and plasma dopamine.
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.
- Being tested
- Retrieval Practice + Moderate Intensity Exercise, Retrieval Practice + Gentle Stretching, Study Only + Moderate Intensity Exercise, Study Only + Gentle Stretching
- Keywords
- aerobic exercise, learning, language, cognition
- Medical subject headings
- Aphasia, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrieval Practice + Moderate Intensity ExerciseBehavioural
Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)
Retrieval Practice + Gentle StretchingBehavioural
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 ExerciseBehavioural
Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
Study Only + Gentle StretchingBehavioural
Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
| Study group | Role | What they receive |
|---|---|---|
| Healthy Older Adults | Experimental | 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) Receives: Behavioral: Retrieval Practice + Moderate Intensity Exercise; Behavioral: Retrieval Practice + Gentle Stretching; Behavioral: Study Only + Moderate Intensity Exercise; Behavioral: Study Only + Gentle Stretching |
| Individuals with Aphasia | Experimental | 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) Receives: Behavioral: Retrieval Practice + Moderate Intensity Exercise; Behavioral: Retrieval Practice + Gentle Stretching; Behavioral: Study Only + Moderate Intensity Exercise; Behavioral: Study Only + Gentle Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Assessment occurs over a two-week period for each of the 4 intervention/arms: Week 1: Monday, Wednesday, Friday, Week 2: Friday
Secondary outcomes (2)
Serum BDNF Concentration Levels (pg/mL)
Blood samples collected to measure serum BDNF concentration levels (pg/mL), as follows:
- Before moderate intensity exercise or gentle stretching
- Immediately after moderate intensity exercise or gentle stretching
- Immediately after word learning
- 15 minutes after word learning
Measured: 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:.
- Before exercise or stretching
- Immediately after exercise or stretching
- Immediately after word learning
- 15 minutes after word learning
Measured: Assessment occurs on Monday, Wednesday and Friday of Week 1 for each of the 4 intervention/arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start9 Dec 2016
- Primary completion16 Aug 2019
- Study completion16 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 2x2 crossover design comparing two learning paradigms (Study Only vs. Retrieval Practice) and two training conditions (Moderate Intensity Exercise vs. Gentle Stretching)
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Amy D. Rodriguez, PhD, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur, GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370471
- Sponsor's protocol ID
- C2238-P
- Status last verified
- Aug 2021
- First submitted
- 10 Oct 2017
- Last updated
- 5 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Exercise Effects on Word Learning in Aging and Stroke-induced Aphasia
- ClinicalTrials.gov ID
- NCT03370471
- Acronym / sponsor ID
- C2238-P
- Keywords
- aerobic exercise, learning, language, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 9 Dec 2016 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 16 Aug 2019 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Posted 5 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- to identify the novel word learning paradigm that facilitates immediate and long-term word recall 2a) to investigate how acute, moderate-intensity exercise alters levels of serum brain-derived neurotrophic factor (BDNF) and plasma dopamine 2b) to describe and quantify the association between novel word learning and any observed changes in serum BDNF and plasma dopamine.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2x2 crossover design comparing two learning paradigms (Study Only vs. Retrieval Practice) and two training conditions (Moderate Intensity Exercise vs. Gentle Stretching)
| Arm | Type | Receives |
|---|---|---|
| Healthy Older Adults | Experimental | Behavioral: Retrieval Practice + Moderate Intensity Exercise, Behavioral: Retrieval Practice + Gentle Stretching, Behavioral: Study Only + Moderate Intensity Exercise, Behavioral: Study Only + Gentle StretchingParticipants 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 | Experimental | Behavioral: Retrieval Practice + Moderate Intensity Exercise, Behavioral: Retrieval Practice + Gentle Stretching, Behavioral: Study Only + Moderate Intensity Exercise, Behavioral: Study Only + Gentle StretchingParticipants 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) |
Who may qualify
- Ages
- 35 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- monolingual English speakers
- "low physical activity" on the International Physical Activity Questionnaire
- physician's written approval for participation in moderate-intensity exercise
Key exclusion criteria (14 listed)
- VO2 max >26 (men) and 22 (women)
- inability to cycle for 3 minutes at 50 revolutions/minute with no resistance
- any comorbid condition with exercise contraindications
- use of hormone replacement therapy
- consumption of >14 alcoholic drinks/week or > 1pack of cigarettes/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrieval Practice + Moderate Intensity ExerciseSubjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning) | Behavioural | Healthy Older Adults, Individuals with Aphasia |
| Retrieval Practice + Gentle StretchingSubject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning) | Behavioural | Healthy Older Adults, Individuals with Aphasia |
| Study Only + Moderate Intensity ExerciseSubjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning) | Behavioural | Healthy Older Adults, Individuals with Aphasia |
| Study Only + Gentle StretchingSubjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning) | Behavioural | Healthy Older Adults, Individuals with Aphasia |
Primary outcome
Study-Specific Word Recall Task
Time frame: Assessment occurs over a two-week period for each of the 4 intervention/arms: Week 1: Monday, Wednesday, Friday, Week 2: Friday
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)
2 secondary outcomes
Serum BDNF Concentration Levels (pg/mL)
Time frame: Assessment occurs on Monday, Wednesday and Friday of Week 1 for each of the 4 intervention/arms
Plasma Dopamine
Time frame: Assessment occurs on Monday, Wednesday and Friday of Week 1 for each of the 4 intervention/arms
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy D. Rodriguez, PhD principal investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrieval Practice + Moderate Intensity Exercise, Retrieval Practice + Gentle Stretching and Study Only + Moderate Intensity Exercise in people with Aging and Aphasia, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study-Specific Word Recall Task (time frame: Assessment occurs over a two-week period for each of the 4 intervention/arms: Week 1: Monday, Wednesday, Friday, Week 2: Friday). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.