- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03370471
Exercise Effects on Word Learning
Acute Exercise Effects on Word Learning in Aging and Stroke-induced Aphasia
Study Overview
Status
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:
1) 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Georgia
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Decatur, Georgia, United States, 30033
- Atlanta VA Medical and Rehab Center, Decatur, GA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- monolingual English speakers
- "low physical activity" on the International Physical Activity Questionnaire
- physician's written approval for participation in moderate-intensity exercise
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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) |
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)
|
|
Experimental: 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) |
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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) |
Assessment occurs over a two-week period for each of the 4 intervention/arms: Week 1: Monday, Wednesday, Friday, Week 2: Friday
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Blood samples collected to measure serum BDNF concentration levels (pg/mL), as follows:
|
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
|
The investigators will collect blood samples to detect changes in plasma dopamine in the training conditions on Monday and Friday sessions, as follows:.
|
Assessment occurs on Monday, Wednesday and Friday of Week 1 for each of the 4 intervention/arms
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C2238-P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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