Exercise as an Adjuvant to Aphasia Therapy

This study has been completed.
Sponsor:
Collaborator:
Brooks Rehabilitation Clinical Research Center
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01113879
First received: April 28, 2010
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

The purpose of the study is to reveal if individuals who participate in aerobic activity demonstrate improvement in language abilities than patients who do not participate in aerobic activity.


Condition Intervention Phase
Aphasia
Behavioral: Aphasia therapy for anomia
Behavioral: Aerobic exercise
Behavioral: Stretching
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise as an Adjuvant to Aphasia Therapy

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • change in picture naming abilities [ Time Frame: administered before and after each of two, two week aphasia therapy blocks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in serum BDNF levels with exercise [ Time Frame: six samples collected over a 16 week period ] [ Designated as safety issue: No ]
  • efficiency of neural processing [ Time Frame: fMRI administered before and after each of two, two week aphasia therapy blocks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2009
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Aphasia therapy with no exercise adjuvant
Behavioral: Aphasia therapy for anomia
The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.
Experimental: Arm 2
Aphasia therapy with an exercise adjuvant
Behavioral: Aphasia therapy for anomia
The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.
Behavioral: Aerobic exercise
An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.
Sham Comparator: Arm 3
Aphasia therapy with a stretching adjuvant
Behavioral: Aphasia therapy for anomia
The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.
Behavioral: Stretching
Stretching will occur for 50 minutes a day, three days/week for 12 weeks.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113879

Locations
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
Brooks Rehabilitation Clinical Research Center
Jacksonville, Florida, United States, 32216
Sponsors and Collaborators
Brooks Rehabilitation Clinical Research Center
Investigators
Principal Investigator: Stacy M. Harnish, PhD CCC/SLP North Florida/South Georgia Veterans Health System
  More Information

Additional Information:
No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01113879     History of Changes
Other Study ID Numbers: C7175-M
Study First Received: April 28, 2010
Last Updated: August 3, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
rehabilitation
aphasia
exercise
fMRI
BDNF

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014