Clinical trial NCT02999360: Aerobic Exercise and Aphasia Treatment
Official title: Aerobic Exercise and Aphasia Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Keywords: Aphasia
Speech Therapy
Aerobic Exercise (AE)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: The Aphasia Communication Outcome Measure (ACOM) (Hula et al., 2015)
timeFrame: 24 Weeks
measure: The Boston Naming Test
timeFrame: 24 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Elizabeth Galletta, MD
role: PRINCIPAL_INVESTIGATOR
References: