What side effects are associated with this type of intervention?

Common treatments for aphasia primarily involve speech therapy, which generally has minimal side effects but can sometimes lead to frustration or emotional distress due to the challenges of communication recovery. When combined with aerobic exercise, as studied in the trial, potential side effects may include physical fatigue, muscle soreness, and the risk of injury if not properly supervised. However, aerobic exercise is also known to enhance cognitive and neuroplastic benefits, potentially improving the outcomes of speech therapy without significant adverse effects.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved drugs for the treatment of aphasia. However, treatments that enhance cognitive and neuroplastic benefits, such as certain medications used for other neurodegenerative conditions, might offer some indirect benefits. The study of combining aerobic exercise with speech therapy is innovative, as aerobic exercise is known to improve overall brain health and cognitive function, potentially enhancing the outcomes of traditional speech therapy for aphasia patients.

What other types of research exist?

Promising novel alternatives to aerobic exercise for enhancing speech therapy outcomes in aphasia patients include cognitive-behavioral therapy (CBT), resistance training, virtual reality (VR) therapy, and non-invasive brain stimulation (NIBS) techniques such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). These approaches have shown potential in improving cognitive function and neuroplasticity, which are essential for effective speech therapy.

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Aerobic Exercise + Speech Therapy for Aphasia

N/A

Waitlist Available

Led By Elizabeth Galleta, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Independent in walking (with or without assistive device)

No significant musculo-skeletal problems from conditions other than stroke

Must not have

Inability to perform required exercises due to medical, musculo-skeletal, or neurological problems

Progressive stroke (primary progressive aphasia diagnosis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Summary

This trial is testing if adding physical exercise to speech therapy can help people with aphasia improve their language skills. The study will see if exercising alongside speech therapy makes the therapy more effective. Exercise might help the brain work better, which could make it easier for patients to improve their speech.

Who is the study for?

This trial is for English-speaking adults who have mild to moderate aphasia from a past stroke (at least 9 months ago) and can walk independently. They must be medically stable with no history of heart attack, significant musculoskeletal issues unrelated to the stroke, or multiple strokes. People with other neurological conditions, current severe psychiatric illnesses, substance addiction, or involvement in another trial cannot participate.

What is being tested?

The study aims to see if combining aerobic exercise with speech therapy helps people with aphasia more than speech therapy alone. Participants will undergo language treatment sessions paired with physical activity and are monitored for improvements in their communication abilities.

What are the potential side effects?

Since this trial involves common activities like exercise and language therapy, side effects may include typical exercise-related discomforts such as muscle soreness or fatigue. However, participants are screened by doctors beforehand to minimize risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk on my own, with or without help from a device.

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I don't have major muscle or bone issues not caused by a stroke.

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I have never had a heart attack.

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I have had one stroke in the past.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot do certain exercises because of health issues.

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I have been diagnosed with primary progressive aphasia.

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I had a stroke caused by bleeding in my brain from a burst blood vessel.

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I have a neurological condition like MS, Parkinson's, or dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

The Boston Naming Test

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment 1Experimental Treatment3 Interventions

Group II: Treatment 2Active Control3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Language therapy

2016

N/A

~20

Aerobic Exercise

2013

Completed Early Phase 1

~1350

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Aphasia treatments commonly involve speech and language therapy, which focuses on improving communication abilities through repetitive and structured practice of language tasks. The mechanisms of action include enhancing neuroplasticity, which is the brain's ability to reorganize and form new neural connections. Combining speech therapy with aerobic exercise can further enhance these benefits by increasing blood flow to the brain, promoting the release of neurotrophic factors, and improving overall cognitive function. This combined approach is significant for aphasia patients as it can lead to more substantial and faster improvements in language skills, thereby enhancing their ability to communicate effectively and improving their quality of life.

An Exercise Mimetic Approach to Reduce Poststroke Deconditioning and Enhance Stroke Recovery.Effects of a multimodal exercise intervention on physical and cognitive functions in patients with chronic low back pain (MultiMove): study protocol for a randomized controlled trial.Alterations to dual stream connectivity predicts response to aphasia therapy following stroke.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,397 Previous Clinical Trials

861,834 Total Patients Enrolled

2 Trials studying Aphasia

25 Patients Enrolled for Aphasia

Elizabeth Galleta, MDPrincipal InvestigatorNYU Langone Medical Center

Elizabeth Galletta, MDPrincipal InvestigatorNYU Langone Medical Center

~1 spots leftby Sep 2025

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