Exercise as an Adjuvant to Aphasia Therapy
May 3, 2019 updated by: VA Office of Research and Development
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32608
- North Florida/South Georgia Veterans Health System
-
Jacksonville, Florida, United States, 32216
- Brooks Rehabilitation Clinical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.
|
|
Placebo Comparator: 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. |
Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
Time Frame: 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.
|
six samples collected over a 16 week period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Stacy M. Harnish, PhD CCC/SLP, North Florida/South Georgia Veterans Health System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2009
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
April 28, 2010
First Submitted That Met QC Criteria
April 28, 2010
First Posted (Estimate)
April 30, 2010
Study Record Updates
Last Update Posted (Actual)
July 22, 2019
Last Update Submitted That Met QC Criteria
May 3, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C7175-M
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.