Back to resultsExercise as an Adjuvant to Aphasia Therapy
Primary Purpose
Aphasia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic exercise
Stretching
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia focused on measuring rehabilitation, aphasia, exercise, BDNF
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
Sites / Locations
- North Florida/South Georgia Veterans Health System
- Brooks Rehabilitation Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Aphasia therapy with an exercise adjuvant
Aphasia therapy with a stretching adjuvant
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01113879
First Posted
April 28, 2010
Last Updated
May 3, 2019
Sponsor
VA Office of Research and Development
Collaborators
Brooks Rehabilitation
1. Study Identification
Unique Protocol Identification Number
NCT01113879
Brief Title
Exercise as an Adjuvant to Aphasia Therapy
Official Title
Exercise as an Adjuvant to Aphasia Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 2009 (Actual)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Brooks Rehabilitation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
rehabilitation, aphasia, exercise, BDNF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aphasia therapy with an exercise adjuvant
Arm Type
Experimental
Arm Description
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.
Arm Title
Aphasia therapy with a stretching adjuvant
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Description
An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.
Intervention Type
Behavioral
Intervention Name(s)
Stretching
Intervention Description
Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
Primary Outcome Measure Information:
Title
Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means
Description
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
Secondary Outcome Measure Information:
Title
Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy M. Harnish, PhD CCC/SLP
Organizational Affiliation
North Florida/South Georgia Veterans Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Brooks Rehabilitation Clinical Research Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29277374
Citation
Harnish SM, Rodriguez AD, Blackett DS, Gregory C, Seeds L, Boatright JH, Crosson B. Aerobic Exercise as an Adjuvant to Aphasia Therapy: Theory, Preliminary Findings, and Future Directions. Clin Ther. 2018 Jan;40(1):35-48.e6. doi: 10.1016/j.clinthera.2017.12.002. Epub 2017 Dec 23.
Results Reference
derived
Links:
URL
http://www.brrc.research.va.gov
Description
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