Exercise as an Adjuvant to Aphasia Therapy

Aphasia Clinical Trial

Official title:

Exercise as an Adjuvant to Aphasia Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113879
• Other study ID #: C7175-M
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: August 2012

Study information

• Verified date: May 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia

Intervention

Behavioral:
• Aerobic exercise
An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.
• Stretching
Stretching will occur for 50 minutes a day, three days/week for 12 weeks.

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida
United States	Brooks Rehabilitation Clinical Research Center	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Brooks Rehabilitation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	administered before and after each of two, two week aphasia therapy blocks
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.	six samples collected over a 16 week period

External Links

•   Click here for more information about this study: Exercise as an Adjuvant to Aphasia Therapy