120 Participants Needed

High-Intensity Exercise for Aphasia

(APEX Trial)

Recruiting at 3 trial locations
MI
Overseen ByMaria Ivanova, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Berkeley
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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 improve recovery for individuals with aphasia (loss of ability to understand or express speech) after a stroke. Participants will be divided into two groups: one will follow a high-intensity workout plan, while the other will engage in a low-intensity routine. Researchers aim to determine if this exercise can enhance physical health and recovery in areas such as language, movement, and mood. Individuals who experienced a stroke more than six months ago and have aphasia might be suitable candidates for this trial. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could enhance recovery strategies for stroke survivors.

Will I have to stop taking my current medications?

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.

What prior data suggests that this high-intensity exercise program is safe for individuals with post-stroke aphasia?

Research has shown that high-intensity exercise programs, like the one being tested for people with post-stroke aphasia, are generally safe. In a previous study, all participants completed the high-intensity interval training (HIIT) without any safety problems. This indicates that people recovering from a stroke can handle this type of exercise well. Participants did not report any issues related to the exercise itself. This finding is encouraging because it suggests that the exercise program can be safely included in recovery plans for those with post-stroke aphasia.12345

Why are researchers excited about this trial?

Researchers are excited about high-intensity physical exercise for aphasia because it introduces a novel approach by using rigorous physical activity to potentially enhance language recovery. Unlike traditional treatments like speech therapy, which focus on language exercises, this method taps into the body's natural response to intense exercise, potentially boosting brain plasticity and recovery. This innovative approach could offer a complementary benefit alongside existing therapies, providing a more holistic path to recovery for individuals with chronic post-stroke aphasia.

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

Research has shown that high-intensity exercise can benefit people with post-stroke aphasia, a condition affecting speech and language. In this trial, participants will join either a high-intensity or low-intensity exercise program. Studies have found that aerobic exercise, a component of high-intensity training, may enhance aphasia therapy outcomes by improving learning and memory. This exercise also boosts heart health and muscle strength, crucial for overall recovery. Moreover, high-intensity exercise does not overly tire stroke survivors, making it suitable for long-term improvement. These findings suggest that high-intensity exercise could enhance physical health, language skills, and cognitive abilities in those with post-stroke aphasia.14678

Who Is on the Research Team?

MI

Maria Ivanova, PhD

Principal Investigator

University of California, Berkeley

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced a stroke and are dealing with aphasia, which affects their speech and language abilities. Participants should be able to engage in physical exercise and commit to a 12-week program. Specific types of aphasia like Wernicke's are included.

Inclusion Criteria

Aphasia as determined by a standardized language test (Western Aphasia Battery Aphasia Quotient < 93.8 at study intake)
Proficient in English before the stroke
At least 8 years of education
See 5 more

Exclusion Criteria

Prior history of dementia, neurologic illness (other than stroke), or recent (last 3 years) substance abuse
Self-report uncontrolled cardiorespiratory and/or metabolic disorders incompatible with exercise
I do not have major sight or hearing issues affecting tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either a high-intensity or low-intensity exercise program delivered over 12 weeks in a group setting

12 weeks
Weekly group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with outcome measures collected to capture short- and long-term effects

12 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview

The study tests whether high-intensity physical exercise helps recovery in post-stroke aphasia patients compared to low-intensity exercise. It measures changes in health, language skills, cognition, motor function, psychological well-being over the course of the program and after.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: High-intensity physical exerciseExperimental Treatment1 Intervention
Group II: Low-intensity physical exerciseActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Berkeley

Lead Sponsor

Trials
193
Recruited
716,000+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

California State University, East Bay

Collaborator

Trials
2
Recruited
40+

University of San Francisco

Collaborator

Trials
10
Recruited
1,300+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

Citations

Aphasia Physical EXercise Study: Randomized Trial

The goal of this clinical trial is to evaluate the effects of a high-intensity exercise program on recovery in individuals with post-stroke ...

Aerobic Exercise as an Adjuvant to Aphasia Therapy

This study investigated whether participation in aerobic exercise enhances the effects of aphasia therapy.

Exercise effects on consolidation of speech and language ...

Post-stroke aphasia severely impacts communication and quality of life. Aerobic exercise enhances learning and memory in healthy adults, with ...

Effects of High-intensity Exercise Training on Physical ...

The goal of this clinical trial is to establish the feasibility and fidelity of a high-intensity exercise program for individuals with post-stroke aphasia.

High-Intensity Aphasia Intervention Is Minimally Fatiguing ...

This study provides evidence that intensive treatment was minimally fatiguing for stroke survivors with chronic aphasia, suggesting that fatigue is not a ...

Physical activity interventions for post-stroke cognitive recovery

Moderate intensity aerobic exercise is considered the most promising approach for enhancing overall cognitive function in patients with ischemic ...

Preliminary Findings | APEX | Current Study

All participants with aphasia safely completed the HIIT exercise program with no incidents concerning the safety of the APEX program itself.

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 ...