Aerobic Exercise and Aphasia Treatment



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 90
Updated:7/15/2018
Start Date:December 19, 2016
End Date:December 2018
Contact:Olanta Chandler
Email:olanta.chandler@nyumc.org
Phone:646-501-7770

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The purpose of the study is to determine if speech therapy can be enhanced by Aerobic
Exercise (AE). Investigators will use a single subject design to determine if aphasia therapy
result in greater gains when combined with aerobic exercise.

Aim 1: To test the feasibility of a research study that combines speech therapy with aerobic
exercise (AE). Participants will be alternately assigned to receiving AE during during a 30
minute break from speech therapy.

Aim 2: To test the preliminary efficacy of combining speech therapy with AE to promote
language improvements in aphasia. These data will inform the design of a large, controlled
clinical trial

Inclusion Criteria:

- Aphasia severity based on Western Aphasia Battery-Revised (WAB-R) aphasia
quotient(AQ)>50. An AQ of 51-75 correlates to moderate aphasia severity and an AQ of
76 and above correlates to mild aphasia severity. Only participants with mild to
moderate aphasia (WAB AQ>50) will be included. The Aphasia Quotient (AQ) is an
essential summary value of the individual's aphasic deficit and is proportional to the
severity of aphasia regardless of the type of aphasia or etiology of aphasia. Type of
aphasia is not an inclusionary/exclusionary criterion because the focus is on language
recovery regardless of aphasia type.

- The inclusionary criterion regarding etiology is aphasia post ischemic stroke; no
specific location of stroke is required.

- Associated cognitive deficits are not a part of the inclusionary/exclusionary criteria
because aphasia is a language disorder and the treatment is a language treatment.

- English is primary language (patient report). Participant may have exposure to another
language however English is the native language and primary language used for
communication premorbidly.

- At least 9 months post CVA (patient report and confirmed by medical records review
when records available). The participant must be at least 9 months post stroke, which
is considered to be the chronic stage therefore there is no restriction on the maximum
number of months/years post stroke.

- Able to participate in AE based on MD screening that follows recommendations for
exercise in stroke patients .

- Have a history of only one stroke.

- Independent in walking (with or without assistive device).

- Medically stable.

- No previous myocardial infarction.

- No significant musculo-skeletal problems from conditions other than stroke.

- History taken by MD and is part of practices standard of care/best practice for
physicians interviewing patients.

Exclusion Criteria:

- MD considers participant unable to comply with study requirements.

- MD evaluates medication history and determines if current medications will have a
negative impact and if so MD will not recommend patient inclusion.

- Mood will first be screened by the Beck Depression Inventory screen and then assessed
with the Beck Depression Inventory (BDI) if the participant does not pass the
screening. This is a 21-item self-report assessment designed specifically to identify
depression. The items are scored 0 (no problem) to 3. Thus, the possible score is
between 0 - 63. A score of 9 or lower is the usual threshold to separate depressed
from non-depressed subjects. If a subject scores 10 or higher the subject will not be
included in the study and the MD will discuss with the subject the possibility of a
referral for a psychiatric evaluation.

- Stroke due to intracranial hemorrhage primarily due to bleeding from ruptured aneurysm
or arteriovenous malformation.

- Progressive stroke (primary progressive aphasia diagnosis)

- Comorbid neurological diagnosis (e.g. MS, PD, dementia)

- Unable to perform the required exercises due to a) medical, b) musculo-skeletal, or c)
neurological problems (for details see below, a-c)

1. medical problems: unstable cardiovascular condition, or other serious cardiac
conditions (for example, anyone meeting New York Heart Association Class IV
criteria, hospitalization for myocardial infarction or heart surgery within 120
days, severe cardiomyopathy or documented serious and unstable cardiac
arrhythmias)

2. musculo-skeletal problems: restricted passive range of motion in the major lower
limb joints (that is, an extension deficit of >20° for the affected hip or knee
joints, or a dorsiflexion deficit of >20° for the affected ankle)

3. neurological problems: severity of stroke-related deficits Required help of at
least 1 person to walk before stroke due to neurological (for example, advanced
Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis) or
non-neurological (for example, heart failure, orthopaedic problems)
co-morbidities with life expectancy of less than 1 year as determined by
physician.

- Drug or alcohol addiction within the last 6 months.

- Significant current psychiatric illness defined as affective disorder unresponsive to
medication or bipolar affective disorder, psychosis, schizophrenia or suicidality.

- Current participation in another interventional trial.

Vulnerable Subjects

- People in this study will have mild to moderate aphasia. Although they have language
problems aphasia is not an intellectual disorder and patient's aphasia will not be
severe. Subjects will have the capacity to consent to participate.

ed deficits Required help of at least 1 person to walk before stroke due to neurological
(for example, advanced Parkinson's disease, amyotrophic lateral sclerosis, multiple
sclerosis) or non-neurological (for example, heart failure, orthopaedic problems)
co-morbidities with life expectancy of less than 1 year as determined by physician.

- Drug or alcohol addiction within the last 6 months.

- Significant current psychiatric illness defined as affective disorder unresponsive to
medication or bipolar affective disorder, psychosis, schizophrenia or suicidality.

- Current participation in another interventional trial.
We found this trial at
1
site
New York, New York 10016
Principal Investigator: Elizabeth Galleta, MD
Phone: 646-501-7770
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New York, NY
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