Aphasia
Conditions
Keywords
rehabilitation, aphasia, exercise, BDNF
Brief summary
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
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.
Interventions
BEHAVIORALAerobic exercise
An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.
BEHAVIORALStretching
Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
Sponsors
Brooks Rehabilitation
VA Office of Research and Development
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means | administered before and after each of two, two week aphasia therapy blocks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise | six samples collected over a 16 week period | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aphasia Therapy With an Exercise Adjuvant 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. | 7 |
| Aphasia Therapy With a Stretching Adjuvant 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. | 2 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1: Block 1 | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Aphasia Therapy With a Stretching Adjuvant | Total | Aphasia Therapy With an Exercise Adjuvant |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 8 Participants | 6 Participants |
| Age, Continuous | 44.5 years STANDARD_DEVIATION 10.6 | 57.9 years STANDARD_DEVIATION 14.4 | 63.2 years STANDARD_DEVIATION 12.5 |
| Boston Naming Test | 21.5 units on a scale | 20.9 units on a scale | 20.6 units on a scale |
| Region of Enrollment United States | 2 Participants | 9 Participants | 7 Participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 4 Participants | 4 Participants |
| Western Aphasia Battery | 60.1 units on a scale | 59 units on a scale | 58.6 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 2 |
| other Total, other adverse events | 0 / 5 | 0 / 2 |
| serious Total, serious adverse events | 0 / 5 | 0 / 2 |
Outcome results
Primary
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.
Time frame: administered before and after each of two, two week aphasia therapy blocks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Aphasia Therapy With an Exercise Adjuvant | Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means | Weighted Tau U for Block 2 | 0.88 Tau U effect size weighted mean |
| Aphasia Therapy With an Exercise Adjuvant | Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means | Weighted Tau U for Block 1 | 0.83 Tau U effect size weighted mean |
| Aphasia Therapy With a Stretching Adjuvant | Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means | Weighted Tau U for Block 1 | 0.75 Tau U effect size weighted mean |
| Aphasia Therapy With a Stretching Adjuvant | Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means | Weighted Tau U for Block 2 | 0.77 Tau U effect size weighted mean |
Comparison: Weighted Tau U effect size mean values in Block 1 of treatment (no aerobic exercise or stretching) were compared to weighted Tau U mean values in Block 2 of treatment (aerobic exercise or stretching adjuvant).p-value: <0.001Weighted Tau U
Secondary
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.
Time frame: six samples collected over a 16 week period
Population: Complete BDNF datasets from 5 of the 7 participants who completed the study were available. BDNF data from the remaining two participants were not collected due to the PI and study team moving locations and no longer having access to the facilities.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aphasia Therapy With an Exercise Adjuvant | Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise | BDNF increased from baseline to six weeks adjuvant | 0 participants |
| Aphasia Therapy With an Exercise Adjuvant | Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise | BDNF increased from first 6 weeks to last 6 weeks | 4 participants |
| Aphasia Therapy With an Exercise Adjuvant | Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise | BDNF decreased from baseline to six week adjuvant | 4 participants |
| Aphasia Therapy With an Exercise Adjuvant | Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise | BDNF decreased from first 6 weeks to last 6 weeks | 0 participants |
| Aphasia Therapy With a Stretching Adjuvant | Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise | BDNF decreased from first 6 weeks to last 6 weeks | 1 participants |
| Aphasia Therapy With a Stretching Adjuvant | Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise | BDNF increased from baseline to six weeks adjuvant | 1 participants |
| Aphasia Therapy With a Stretching Adjuvant | Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise | BDNF decreased from baseline to six week adjuvant | 0 participants |
| Aphasia Therapy With a Stretching Adjuvant | Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise | BDNF increased from first 6 weeks to last 6 weeks | 0 participants |