An interventional study of Aerobic exercise and Stretching in Aphasia, sponsored by VA Office of Research and Development. Completed at 2 sites in United States. Open to participants aged 20 Years to 95 Years. Per ClinicalTrials.gov, last updated 2019-07-22.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
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.
365 studies on the registry are indexed under Aphasia; 89 are open to participants now.
This study's enrollment of 9 is below the median of 30 across 316 interventional studies indexed under Aphasia.
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Exclusion Criteria:
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
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
An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.
Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
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
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
| Milestone | Aphasia Therapy Alone, Then With Exercise | Aphasia Therapy Alone, Then With Stretching |
|---|---|---|
| Started | 7 | 2 |
| Completed | 5 | 2 |
| Not completed | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Milestone | Aphasia Therapy Alone, Then With Exercise | Aphasia Therapy Alone, Then With Stretching |
|---|---|---|
| Started | 5 | 2 |
| Completed | 5 | 2 |
| Not completed | 0 | 0 |
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.
| Tau U effect size weighted mean | Aphasia Therapy With an Exercise Adjuvant | Aphasia Therapy With a Stretching Adjuvant |
|---|---|---|
| Weighted Tau U for Block 1 | 0.83 (0.67 to 1.00) | 0.75 (0.49 to 1.00) |
| Weighted Tau U for Block 2 | 0.88 (0.71 to 1.00) | 0.77 (0.50 to 1.00) |
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.
| participants | Aphasia Therapy With an Exercise Adjuvant | Aphasia Therapy With a Stretching Adjuvant |
|---|---|---|
| BDNF increased from baseline to six weeks adjuvant | 0 | 1 |
| BDNF increased from first 6 weeks to last 6 weeks | 4 | 0 |
| BDNF decreased from baseline to six week adjuvant | 4 | 0 |
| BDNF decreased from first 6 weeks to last 6 weeks | 0 | 1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aphasia Therapy With an Exercise Adjuvant | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Aphasia Therapy With a Stretching Adjuvant | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Aphasia Therapy With an Exercise Adjuvant | Aphasia Therapy With a Stretching Adjuvant | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 2 | 8 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(years) | Aphasia Therapy With an Exercise Adjuvant | Aphasia Therapy With a Stretching Adjuvant | Total |
|---|---|---|---|
| Mean | 63.2 ± 12.5 | 44.5 ± 10.6 | 57.9 ± 14.4 |
| Sex: Female, Male(Participants) | Aphasia Therapy With an Exercise Adjuvant | Aphasia Therapy With a Stretching Adjuvant | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 4 | 0 | 4 |
| Region of Enrollment(Participants) | Aphasia Therapy With an Exercise Adjuvant | Aphasia Therapy With a Stretching Adjuvant | Total |
|---|---|---|---|
| United States | 7 | 2 | 9 |
| Boston Naming Test(units on a scale) | Aphasia Therapy With an Exercise Adjuvant | Aphasia Therapy With a Stretching Adjuvant | Total |
|---|---|---|---|
| Mean | 20.6 (10 to 43) | 21.5 (4 to 39) | 20.9 (4 to 43) |
| Western Aphasia Battery(units on a scale) | Aphasia Therapy With an Exercise Adjuvant | Aphasia Therapy With a Stretching Adjuvant | Total |
|---|---|---|---|
| Mean | 58.6 (43.5 to 80.7) | 60.1 (35.8 to 84.4) | 59 (35.8 to 80.7) |
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