Exercise as an Adjuvant to Aphasia Therapy

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: Aphasia
• Intervention / Treatment: Behavioral: Aerobic exercise; Behavioral: Stretching

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

Study Locations

• United States
  • 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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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.	Behavioral: Aerobic exercise; 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.	Behavioral: Stretching; 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	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	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

• Sponsor: VA Office of Research and Development
• Collaborators: Brooks Rehabilitation
• Investigators: Principal Investigator: Stacy M. Harnish, PhD CCC/SLP, North Florida/South Georgia Veterans Health System

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

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: exercise; rehabilitation; BDNF; aphasia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• 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