Exercise as an Adjuvant to Aphasia Therapy

NCT01113879 | Completed Results

• 1 other identifier: C7175-M
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Aphasia

Keywords

rehabilitation; aphasia; exercise; BDNF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise

  six samples collected over a 16 week period

Study Arms (2)

Aphasia therapy with an exercise adjuvant

EXPERIMENTAL

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

Aphasia therapy with a stretching adjuvant

PLACEBO COMPARATOR

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

Interventions

Aerobic exercise BEHAVIORAL

An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.

Aphasia therapy with an exercise adjuvant

Stretching BEHAVIORAL

Stretching will occur for 50 minutes a day, three days/week for 12 weeks.

Aphasia therapy with a stretching adjuvant

Eligibility Criteria

• Age: 20 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-stroke aphasia
• at least 6 months post-stroke
• at least minimally intact auditory verbal comprehension
• pre-morbidly right handed
• native English speaker

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Brooks Rehabilitation: collaborator

Study Sites (2)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

Brooks Rehabilitation Clinical Research Center

Jacksonville, Florida, 32216, United States

Location

Related Publications (1)

• 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.

  PMID: 29277374 DERIVED

Related Links

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

MeSH Terms

Conditions

Aphasia; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Stacy Harnish
• Organization: The Ohio State University

harnish.18@osu.edu

614-688-1471

Study Officials

• Stacy M. Harnish, PhD CCC/SLP

  North Florida/South Georgia Veterans Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: April 30, 2010
• Study Start: July 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 22, 2019
• Results First Posted: July 22, 2019

Record last verified: 2019-05

Locations

US (2)