NCT03370471

Exercise Effects on Word Learning

Completed NA Results posted Last updated 5 September 2021

What this trial tests

NA trial testing Retrieval Practice + Moderate Intensity Exercise in Aging in 28 participants. Completed in 16 August 2019.

Timeline

9 December 2016

Primary endpoint
16 August 2019

16 August 2019

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	28
Start date	9 December 2016
Primary completion	16 August 2019
Estimated completion	16 August 2019
Sites	1 location across United States

Drugs / interventions tested

• Retrieval Practice + Moderate Intensity Exercise
• Retrieval Practice + Gentle Stretching
• Study Only + Moderate Intensity Exercise
• Study Only + Gentle Stretching

Conditions studied

• Aging — all drugs for Aging →
• Aphasia — all drugs for Aphasia →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 35 to 89, any sex, with Aging or Aphasia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Study-Specific Word Recall Task Primary · 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)

Acquisition- Retrieval Practice + Moderate Intensity Exercise

Group	Value	95% CI
Healthy Older Adults	6.4	± 3.6
Individuals With Aphasia	1.7	± 2.1

Consolidation- Retrieval Practice + Moderate Intensity Exercise

Group	Value	95% CI
Healthy Older Adults	4.6	± 4.1
Individuals With Aphasia	1.5	± 2.1

Acquisition- Retrieval Practice + Gentle Stretching

Group	Value	95% CI
Healthy Older Adults	4.8	± 3.8
Individuals With Aphasia	1.7	± 2.5

Consolidation- Retrieval Practice + Gentle Stretching

Group	Value	95% CI
Healthy Older Adults	4.6	± 4.5
Individuals With Aphasia	0.7	± 2.1

Acquisition- Study Only + Moderate Intensity Exercise

Group	Value	95% CI
Healthy Older Adults	4.8	± 3.6
Individuals With Aphasia	1.7	± 3.8

Consolidation- Study Only + Moderate Intensity Exercise

Group	Value	95% CI
Healthy Older Adults	3.6	± 3.2
Individuals With Aphasia	1.3	± 2.3

Acquisition- Study Only + Gentle Stretching

Group	Value	95% CI
Healthy Older Adults	5.4	± 2.7
Individuals With Aphasia	2.7	± 2.9

Consolidation- Study Only + Gentle Stretching

Group	Value	95% CI
Healthy Older Adults	3.5	± 3.6
Individuals With Aphasia	1.3	± 2.3

Serum BDNF Concentration Levels (pg/mL) Secondary · 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: 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

Moderate Intensity Exercise- Before Exercise

Group	Value	95% CI
Healthy Older Adults	195.50	± 36.00
Individuals With Aphasia	137.83	± 51.88

Moderate Intensity Exercise- Immediately After Exercise

Group	Value	95% CI
Healthy Older Adults	218.98	± 79.39
Individuals With Aphasia	156.01	± 70.25

Moderate Intensity Exercise- Immediately After Learning

Group	Value	95% CI
Healthy Older Adults	209.95	± 75.70
Individuals With Aphasia	153.70	± 28.94

Moderate Intensity Exercise- 15 Minutes After Learning

Group	Value	95% CI
Healthy Older Adults	204.17	± 57.36
Individuals With Aphasia	129.34	± 12.90

Gentle Stretching- Before Stretching

Group	Value	95% CI
Healthy Older Adults	199.92	± 48.72
Individuals With Aphasia	180.25	± 42.48

Gentle Stretching- Immediately After Stretching

Group	Value	95% CI
Healthy Older Adults	217.14	± 49.33
Individuals With Aphasia	201.19	± 93.51

Gentle Stretching- Immediately After Learning

Group	Value	95% CI
Healthy Older Adults	222.03	± 58.78
Individuals With Aphasia	140.85	± 23.66

Gentle Stretching- 15 Minutes After Learning

Group	Value	95% CI
Healthy Older Adults	218.00	± 60.00
Individuals With Aphasia	117.76	± 40.87

Word Recognition Secondary · Assessment occurs over a two-week period for each of the 4 intervention/arms: Week 1: Monday, Wednesday, Friday, Week 2: Friday

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)

Acquisition- Retrieval Practice + Moderate Intensity Exercise

Group	Value	95% CI
Healthy Older Adults	3.1	± 2.3
Individuals With Aphasia	4.0	± 1.7

Consolidation- Retrieval Practice + Moderate Intensity Exercise

Group	Value	95% CI
Healthy Older Adults	3.0	± 3.0
Individuals With Aphasia	3.5	± .07

Acquisition- Retrieval Practice + Gentle Stretching

Group	Value	95% CI
Healthy Older Adults	3.1	± 2.0
Individuals With Aphasia	3.0	± 3.5

Consolidation- Retrieval Practice + Gentle Stretching

Group	Value	95% CI
Healthy Older Adults	2.9	± 2.6
Individuals With Aphasia	-1.7	± 1.5

Acquisition- Study Only + Moderate Intensity Exercise

Group	Value	95% CI
Healthy Older Adults	2.7	± 2.2
Individuals With Aphasia	2.3	± 1.5

Consolidation- Study Only + Moderate Intensity Exercise

Group	Value	95% CI
Healthy Older Adults	1.8	± 2.4
Individuals With Aphasia	0.3	± 2.1

Acquisition- Study Only + Gentle Stretching

Group	Value	95% CI
Healthy Older Adults	1.9	± 2.2
Individuals With Aphasia	2.7	± 3.1

Consolidation- Study Only + Gentle Stretching

Group	Value	95% CI
Healthy Older Adults	3.2	± 2.8
Individuals With Aphasia	1.7	± 0.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Healthy Older Adults

Serious: 0/23 (0%)

Deaths: 0/23

Individuals With Aphasia

Serious: 0/5 (0%)

Deaths: 0/5

Other adverse events (2 terms — click to expand)

Reaction	System	Healthy Older Adults	Individuals With Aphasia
Dizziness and Syncope	General disorders	—	—
Skin Burn	Injury, poisoning and procedural complications	—	—

Data from ClinicalTrials.gov NCT03370471 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.