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Completed

NCT Number: NCT01113879

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.

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Key information

Conditions

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

Age range

20 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Florida/South Georgia Veterans Health System, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Behavioral

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

Stretching

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Brooks Rehabilitation

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 30, 2010
Registry last updated
Jul 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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