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Clinical Trials/NCT01113879
NCT01113879
Completed
Not Applicable

Exercise as an Adjuvant to Aphasia Therapy

VA Office of Research and Development2 sites in 1 country9 target enrollmentJuly 2009
ConditionsAphasia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aphasia
Sponsor
VA Office of Research and Development
Enrollment
9
Locations
2
Primary Endpoint
Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
August 2012
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means

Time Frame: 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 Outcomes

  • Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise(six samples collected over a 16 week period)

Study Sites (2)

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