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Exercise Effects on Word Learning

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ClinicalTrials.gov Identifier: NCT03370471
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Aging Aphasia Behavioral: Moderate Intensity Exercise Behavioral: Gentle Stretching Not Applicable

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 and 16 individuals with aphasia, age 65-89 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, and 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Acute Exercise Effects on Word Learning in Aging and Stroke-induced Aphasia
Actual Study Start Date : December 9, 2016
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Study Only
Subject uses their own strategy for learning words; no active retrieval during learning.
Behavioral: Moderate Intensity Exercise
Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning.

Behavioral: Gentle Stretching
Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning.

Active Comparator: Retrieval Practice
Subject actively retrieves words as prompted during learning.
Behavioral: Moderate Intensity Exercise
Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning.

Behavioral: Gentle Stretching
Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning.




Primary Outcome Measures :
  1. Study-specific word recall task (informal assessment that comprises the words trained in each intervention and arm) [ Time Frame: Change between sessions 1, 2, 3, and 4 in each intervention/arm (up to 12 weeks) ]

    The ability to recall words will be measured at 6 time points in each intervention and arm, as follows:

    1. Immediately before exercise or stretching on Wednesday, and Friday.
    2. Immediately after exercise or stretching on Monday, Wednesday and Friday.
    3. One week after learning on a Friday.


Secondary Outcome Measures :
  1. Serum BDNF [ Time Frame: Change within sessions 1 and 3 in each intervention/arm (up to 12 weeks) ]

    The investigators will collect blood samples to detect changes in serum BDNF 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

  2. Plasma dopamine [ Time Frame: Change within sessions 1 and 3 in each intervention/arm (up to 12 weeks) ]

    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



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 89 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370471


Contacts
Contact: Amy D Rodriguez, PhD amy.rodriguez@va.gov

Locations
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA Recruiting
Decatur, Georgia, United States, 30033
Contact: Amy D Rodriguez, PhD       amy.rodriguez@va.gov   
Principal Investigator: Amy D. Rodriguez, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Amy D. Rodriguez, PhD Atlanta VA Medical and Rehab Center, Decatur, GA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03370471     History of Changes
Other Study ID Numbers: C2238-P
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
aerobic exercise
learning
language
cognition

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms