Aerobic Exercise and Aphasia Treatment

NCT02999360 | Completed

• 1 other identifier: 16-00960
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia

Keywords

Aphasia; Speech Therapy; Aerobic Exercise (AE)

Outcome Measures

Primary Outcomes (2)

• The Aphasia Communication Outcome Measure (ACOM) (Hula et al., 2015)

  Patient-reported outcome measure of communicative functioning for persons with aphasia

  24 Weeks

• The Boston Naming Test

  The examiner begins with Item 1 and continues through Item 60, unless the patient is in distress or refuses to continue. The patient is told to tell the examiner the name of each picture and is given about 20 seconds to respond for each trial. The examiner writes down the patient's responses in detail, using codes. If the patient fails to give the correct response, the examiner at her or his discretion may give the patient a phonemic cue, which is the initial sound of the target word. After the patient completes the test, the examiner scores each item + or - according to the response coding and scoring procedures

  24 Weeks

Study Arms (2)

Treatment 1

EXPERIMENTAL

Behavioral: Language therapy; Behavioral: Background Music; Behavioral: Aerobic Exercise

Treatment 2

ACTIVE COMPARATOR

Behavioral: Language therapy; Behavioral: Background Music; Behavioral: Aerobic Exercise

Interventions

Language therapy BEHAVIORAL

There will be three blocks of treatment, ideally three times a week 100 minutes per day. Treatment will target impairment-directed speech language therapy (SLT) approaches or compensatory-directed SLT in each of the three treatment blocks. Half of the participants will receive the impairment-directed SLT. Half of the participants, will receive treatment that will target compensatory-directed speech language therapy approaches that are focused on functional communication skills in the conversational context. Methods of treatment will include PACE (Promoting Aphasics Communicative Effectiveness (Davis, 2005), conversational coaching (Hopper et al., 2002), and supported conversation (Kagan et al., 2001). The clinician will model and encourage all (verbal and non verbal) modalities of communication.

Treatment 1; Treatment 2

Background Music BEHAVIORAL

30 minutes background music only

Treatment 1; Treatment 2

Aerobic Exercise BEHAVIORAL

There will be three blocks of treatment and the AE will take place for all participants during one or two treatment blocks (randomly assigned), threetimes a week (sessions are three times a week prior to speech therapy but may be one or two times a week if a session is missed or may be up to four or five times a week if one or two sessions are missed and rescheduled due to weather or other circumstances).

Also known as: AE

Treatment 1; Treatment 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• MD considers participant unable to comply with study requirements.
• 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)
• 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)
• 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)
• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Aphasia; Communication Disorders

Interventions

Language Therapy; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Elizabeth Galletta, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 21, 2016
• Study Start: December 19, 2016
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

US (1)