AphasiaNCT02999360
Aerobic Exercise and Aphasia Treatment
A study testing Language therapy, Background Music and Aerobic Exercise in people with Aphasia, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aphasia
- What is being tested?
- Language therapy, Background Music and Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2016to 20 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
Show all 12Show fewer
- 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.
Who cannot join
- 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)
Show all 19Show fewer
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
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.
Read the 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
- Conditions
- Aphasia
- Being tested
- Language therapy, Background Music, Aerobic Exercise
- Keywords
- Aphasia, Speech Therapy, Aerobic Exercise (AE)
- Medical subject headings
- Aphasia, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Language therapyBehavioural
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.
Background MusicBehavioural
30 minutes background music only
Aerobic ExerciseBehavioural
Also called AE
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | Not described Receives: Behavioral: Language therapy; Behavioral: Background Music; Behavioral: Aerobic Exercise |
| Treatment 2 | Active comparator | Not described Receives: Behavioral: Language therapy; Behavioral: Background Music; Behavioral: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Aphasia Communication Outcome Measure (ACOM) (Hula et al., 2015)
Patient-reported outcome measure of communicative functioning for persons with aphasia
Measured: 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
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start19 Dec 2016
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Galletta, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999360
- Sponsor's protocol ID
- 16-00960
- Status last verified
- Nov 2024
- First submitted
- 19 Dec 2016
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercise and Aphasia Treatment
- ClinicalTrials.gov ID
- NCT02999360
- Acronym / sponsor ID
- 16-00960
- Conditions
- Aphasia
- Keywords
- Aphasia, Speech Therapy, Aerobic Exercise (AE)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Language therapyThere 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. | Behavioural | Treatment 1, Treatment 2 |
| Background Music30 minutes background music only | Behavioural | Treatment 1, Treatment 2 |
| Aerobic ExerciseAlso: AEThere 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). | Behavioural | Treatment 1, Treatment 2 |
Primary outcome
The Aphasia Communication Outcome Measure (ACOM) (Hula et al., 2015)
Time frame: 24 Weeks
Patient-reported outcome measure of communicative functioning for persons with aphasia
The Boston Naming Test
Time frame: 24 Weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Aphasia
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Enrolling by invitation
Effects of Semantic Context on Criterion-learning Naming Treatment in Aphasia
Aphasia
Not yet recruiting
Personalized Closed-Loop Brain Stimulation for Patients With Primary Progressive Aphasia
PPA
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
RecruitingObservational study
Speech and Language Interventions for Italian People With PPA
Primary Progressive Aphasia(PPA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Galletta, MD principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Language therapy, Background Music and Aerobic Exercise in people with Aphasia, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Aphasia Communication Outcome Measure (ACOM) (Hula et al., 2015) (time frame: 24 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.