Exercise Effects on Word Learning

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT03370471
Collaborator
(none)
28
1
2
32.2
0.9

Study Details

Study Description

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
  • Behavioral: Retrieval Practice + Moderate Intensity Exercise
  • Behavioral: Retrieval Practice + Gentle Stretching
  • Behavioral: Study Only + Moderate Intensity Exercise
  • Behavioral: Study Only + Gentle Stretching
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
28 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)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 :
Dec 9, 2016
Actual Primary Completion Date :
Aug 16, 2019
Actual Study Completion Date :
Aug 16, 2019

Arms and Interventions

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)

Behavioral: 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)

Behavioral: 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)

Behavioral: 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)

Behavioral: 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)

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)

Behavioral: 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)

Behavioral: 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)

Behavioral: 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)

Behavioral: 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)

Outcome Measures

Primary Outcome Measures

  1. Study-Specific Word Recall Task [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)

Secondary Outcome Measures

  1. Serum BDNF Concentration Levels (pg/mL) [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: Before moderate intensity exercise or gentle stretching Immediately after moderate intensity exercise or gentle stretching Immediately after word learning 15 minutes after word learning

  2. Plasma Dopamine [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:. Before exercise or stretching Immediately after exercise or stretching Immediately after word learning 15 minutes after word learning

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Atlanta VA Medical and Rehab Center, Decatur, GA Decatur Georgia United States 30033

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: Amy D. Rodriguez, PhD, Atlanta VA Medical and Rehab Center, Decatur, GA

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT03370471
Other Study ID Numbers:
  • C2238-P
First Posted:
Dec 12, 2017
Last Update Posted:
Sep 5, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Healthy Older Adults Individuals With Aphasia
Arm/Group Description 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) 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)
Period Title: Overall Study
STARTED 23 5
COMPLETED 16 3
NOT COMPLETED 7 2

Baseline Characteristics

Arm/Group Title Healthy Older Adults Individuals With Aphasia Total
Arm/Group Description 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) 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 of all reporting groups
Overall Participants 16 3 19
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
74.1
(5.1)
57.7
(21.1)
71.5
(10.4)
Sex: Female, Male (Count of Participants)
Female
7
43.8%
2
66.7%
9
47.4%
Male
9
56.3%
1
33.3%
10
52.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
0
0%
0
0%
Not Hispanic or Latino
16
100%
3
100%
19
100%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
4
25%
1
33.3%
5
26.3%
White
11
68.8%
2
66.7%
13
68.4%
More than one race
1
6.3%
0
0%
1
5.3%
Unknown or Not Reported
0
0%
0
0%
0
0%
Region of Enrollment (Count of Participants)
United States
16
100%
3
100%
19
100%

Outcome Measures

1. Primary Outcome
Title Study-Specific Word Recall Task
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Older Adults Individuals With Aphasia
Arm/Group Description 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) 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)
Measure Participants 16 3
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)
2. Secondary Outcome
Title Serum BDNF Concentration Levels (pg/mL)
Description 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
Time Frame Assessment occurs on Monday, Wednesday and Friday of Week 1 for each of the 4 intervention/arms

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Older Adults Individuals With Aphasia
Arm/Group Description 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) 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)
Measure Participants 13 2
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)
3. Secondary Outcome
Title Plasma Dopamine
Description 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
Time Frame Assessment occurs on Monday, Wednesday and Friday of Week 1 for each of the 4 intervention/arms

Outcome Measure Data

Analysis Population Description
We were not able to obtain reliable measurements of dopamine for analysis.
Arm/Group Title Healthy Older Adults Individuals With Aphasia
Arm/Group Description 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) 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)
Measure Participants 0 0
4. Post-Hoc Outcome
Title Word Recognition
Description 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)
Time Frame Assessment occurs over a two-week period for each of the 4 intervention/arms: Week 1: Monday, Wednesday, Friday, Week 2: Friday

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Older Adults Individuals With Aphasia
Arm/Group Description 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) 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)
Measure Participants 16 3
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)

Adverse Events

Time Frame 3 months
Adverse Event Reporting Description
Arm/Group Title Healthy Older Adults Individuals With Aphasia
Arm/Group Description 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) 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)
All Cause Mortality
Healthy Older Adults Individuals With Aphasia
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/23 (0%) 0/5 (0%)
Serious Adverse Events
Healthy Older Adults Individuals With Aphasia
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/23 (0%) 0/5 (0%)
Other (Not Including Serious) Adverse Events
Healthy Older Adults Individuals With Aphasia
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/23 (4.3%) 1/5 (20%)
General disorders
Dizziness and Syncope 1/23 (4.3%) 1 0/5 (0%) 0
Injury, poisoning and procedural complications
Skin Burn 0/23 (0%) 0 1/5 (20%) 1

Limitations/Caveats

Participants: We were not able to recruit the target number of participants with aphasia. Our small numbers in this arm prevented us from conducting reliable statistical analyses of these data. Technical problems: We were not able to obtain reliable measurements of dopamine. This hindered completion of our secondary analysis related to the association between word learning and changes in dopamine with exercise and stretching.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Amy D Rodriguez, PhD
Organization Atlanta VA Health Care System
Phone 404-321-6111 ext 204201
Email amy.rodridguez@va.gov
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT03370471
Other Study ID Numbers:
  • C2238-P
First Posted:
Dec 12, 2017
Last Update Posted:
Sep 5, 2021
Last Verified:
Aug 1, 2021