Exercise as an Adjuvant to Aphasia Therapy

Study Overview
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Brief Summary
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The purpose of the study is to reveal if individuals who participate in aerobic activity demonstrate greater improvement in language abilities than patients who do not participate in aerobic activity.

Detailed Description
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The objective of this research project is to reveal if individuals who participate in aerobic activity demonstrate greater improvement in language abilities with treatment than patients who do not participate in aerobic activity. As secondary objectives, we will determine if there is a direct relationship between either brain efficiency or increases in Brain Derived Neurotrophic Factor (BDNF) after exercise and higher learning rates in aphasia.

Official Title
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Exercise as an Adjuvant to Aphasia Therapy

Conditions
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Aphasia

Intervention / Treatment
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* Behavioral: Aerobic exercise
* Behavioral: Stretching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-stroke aphasia at least 6 months post-stroke at least minimally intact auditory verbal comprehension pre-morbidly right handed native English speaker Exclusion Criteria: contraindications for fMRI (metal implants, claustrophobia) inability to pass an exercise tolerance test significant depression uncorrected hearing or vision problems severe apraxia of speech regularly perform 20 minutes of cardiovascular exercise 3 times per week

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study used a single-subject, multiple-baseline design across behaviors. Following assessment and baseline procedures, participants completed 2 therapy periods: Block 1 was aphasia therapy alone, and Block 2 was aphasia therapy plus aerobic exercise or stretching.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aphasia therapy with an exercise adjuvant<br>Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects. Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate. | Behavioral: Aerobic exercise<br>* An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.<br>|
| Placebo Comparator: Aphasia therapy with a stretching adjuvant<br>Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects. Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks. | Behavioral: Stretching<br>* Stretching will occur for 50 minutes a day, three days/week for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means | Tau-U effect sizes of <0.20 were considered small; 0.20 to <0.60 moderate; 0.60 to <0.80 large, and >=0.80 very large. Weighted Tau-U averages in exercise participants and stretching participants were calculated in each block using an online web-based calculator (http://www.singleresearch.org/calculators/tau-u). In the present analysis, any baseline trends over 0.10 were adjusted. | administered before and after each of two, two week aphasia therapy blocks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise | The baseline BDNF levels in participants (ie, the 2 measures prior to the exercise or stretching interventions) showed a great deal of intraparticipant variation. Hence, in an attempt to minimize the intraparticipant variability, we calculated the mean values from samples 1 and 2 to obtain a baseline BDNF measure, samples 3 and 4 to obtain a BDNF measure in the first 6 weeks of aerobic exercise or stretching, and samples 5 and 6 to obtain a measure in the last 6 weeks of the exercise or stretching intervention. | six samples collected over a 16 week period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, aphasia, exercise, BDNF