High-Intensity Exercise for Aphasia

Not currently recruiting at 3 trial locations

Overseen By Maria Ivanova, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Berkeley

Disqualifiers: Dementia, Neurologic illness, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a high-intensity exercise program can benefit people with aphasia, a language disorder caused by strokes. Researchers aim to determine if stroke survivors can adhere to these exercise routines and whether they improve physical fitness, thinking skills, language abilities, or mood. Participants will engage in either high-intensity or low-intensity exercises to compare the effects. The trial seeks individuals who have experienced a stroke with aphasia, are at least six months past their last stroke, and can walk independently. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery options for stroke survivors.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that high-intensity exercise is generally safe for people with aphasia. Previous studies found that people with aphasia can successfully participate in these exercise programs, completing sessions without major issues. No significant harmful effects were reported, indicating that serious side effects are rare.

Although specific details on negative effects are lacking, the absence of major problems in earlier studies is encouraging. This suggests that high-intensity exercise is well-tolerated by those who have had a stroke and are living with aphasia.

Overall, the evidence supports that this type of exercise program is safe and manageable for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about high-intensity physical exercise for aphasia because it offers a novel approach to therapy. Unlike traditional treatments focusing on speech and language rehabilitation, this method leverages the body's physical activity to potentially enhance brain function and language recovery. The unique aspect of the remote delivery via live Zoom classes also makes this treatment accessible to more individuals, allowing them to participate from the comfort of their homes. By integrating physical exercise into aphasia treatment, this approach could bring an innovative and complementary angle to existing rehabilitation strategies.

What evidence suggests that this trial's exercise interventions could be effective for post-stroke aphasia?

Research has shown that intense exercise can benefit stroke survivors. In this trial, participants will join different exercise programs. One group will engage in high-intensity physical exercise, which studies have found can enhance thinking and language skills in individuals with post-stroke aphasia, a condition affecting speech. Another group will participate in low-intensity physical exercise. Specifically, one study noted that individuals who performed high-intensity exercise experienced greater mental improvements than those who received regular care. Additionally, intense physical activity is linked to better movement and overall health. These findings suggest that a targeted exercise program might help individuals with aphasia regain some lost abilities. ^{1 2 4 5 6}

Who Is on the Research Team?

Maria Ivanova, PhD

Principal Investigator

University of California, Berkeley

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-80 who have had a stroke resulting in aphasia, are at least 6 months post-stroke, spoke English proficiently before the stroke, and have completed at least 8 years of education. They must be able to walk on their own or with a cane and cleared by a doctor for physical exercise. Those with dementia, other neurological illnesses besides stroke, substance abuse issues, significant visual/hearing disabilities, or uncontrolled heart/lung/metabolic conditions cannot participate.

Inclusion Criteria

Proficient in English before the stroke

At least 8 years of education

I have difficulty speaking due to a stroke in the left side of my brain.

Exclusion Criteria

Per self-report uncontrolled cardiorespiratory and/or metabolic disorders incompatible with exercise

Significant visual or hearing disabilities (e.g., neglect, uncorrected visual or hearing loss) that interfere with testing

Prior history of dementia, neurologic illness (other than stroke), or substance abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Low-intensity Intervention

Participants engage in a low-intensity non-aerobic exercise program

2 weeks

In-person sessions

High-intensity Intervention (Remote)

Participants take part in a high-intensity Aphasia Physical EXercise (APEX) intervention remotely

4 weeks

1 in-person visit, followed by remote sessions via Zoom

High-intensity Intervention

Participants take part in a high-intensity Aphasia Physical EXercise (APEX) intervention

8 weeks

In-person sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High-intensity physical exercise
• Low-intensity physical exercise

Trial Overview The study is testing whether people with post-stroke aphasia can stick to an intense workout program and if it helps improve their fitness level as well as cognitive and language abilities. Participants will either do low-intensity exercises (as a control group) or high-intensity workouts (as the target intervention).

How Is the Trial Designed?

Group I: High-intensity physical exercise - remote Experimental Treatment 1 Intervention

The participants will take part in a high-intensity Aphasia Physical EXercise (APEX) intervention designed specifically for individuals with chronic post-stroke aphasia for 4 weeks. The first week will be delivered in-person, while weeks 2-4 will be delivered remotely via live Zoom classes.

Group II: High-intensity physical exercise Experimental Treatment 1 Intervention

The participants will take part in a high-intensity Aphasia Physical EXercise (APEX) intervention designed specifically for individuals with chronic post-stroke aphasia for 8 weeks.

Group III: Low-intensity physical exercise Active Control 1 Intervention

The participants will participate in a low-intensity non-aerobic exercise program for 2 weeks.

Who Is Running the Clinical Trial?

University of California, Berkeley

Lead Sponsor

Trials

193

Recruited

716,000+

California State University, East Bay

Collaborator

Trials

2

Recruited

40+

University of San Francisco

Collaborator

Trials

10

Recruited

1,300+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Citations

1. apex.berkeley.edu apex.berkeley.edu/

APEX | Current Study | The Aphasia Physical EXercise Project This is a novel high-intensity physical exercise program designed specifically for stroke survivors, made to enhance language, cognitive, motor and physical ...

2. reporter.nih.gov reporter.nih.gov/search/O7kjhbnAbEKg5yDUhAt_Jg/project-details/11106862

Exercising language - NIH RePORTER We will recruit 110 individuals with aphasia to evaluate the multi-faceted impact of high-intensity exercise on outcomes and compare its effects to an active ...

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06185023

UCSF Aphasia Trial → High-intensity Exercise Training on ... The goal of this clinical trial is to establish the feasibility and fidelity of a high-intensity exercise program for individuals with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12434964/

Physical activity interventions for post-stroke cognitive recovery The findings revealed that compared with routine medical care, multi-modal exercise significantly improved cognitive function (SMD = −5.58, 95% ...

5. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.045183

High-Intensity Aphasia Therapy Is Cost-Effective in People ... We observed that both treatments, but especially M-MAT, may result in better outcomes at an acceptable additional cost, or potentially with cost savings.

6. apex.berkeley.edu apex.berkeley.edu/preliminary-findings/

Preliminary Findings | APEX | Current Study Our pilot data clearly demonstrated that people with aphasia can successfully engage in the high-intensity exercise program. The program effectively ...