Aphasia, AcquiredNCT06185023
Effects of High-intensity Exercise Training on Physical Fitness, Cognition, Language in Post-stroke Aphasia
A study testing Low-intensity physical exercise and High-intensity physical exercise in people with Aphasia, Acquired and Aphasia, run by University of California, Berkeley at 4 sites in United States.
Trial summary
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. The main questions it aims to answer are: Is it feasible for stroke survivors with aphasia to participate in a long in-person physical exercise program? Does… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aphasia, Acquired, Aphasia, Aphasia, Fluent
- What is being tested?
- Low-intensity physical exercise and High-intensity physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Dec 2023to 15 Jan 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aphasia following single or multiple ischemic or hemorrhagic stroke;
- at least 6 months from the last stroke;
- proficient in English before the stroke;
- at least 8 years of education;
- between the ages of 18 and 80;
- independent with ambulation without a device (single-point cane accepted);
- medically stable with no contraindications to participate in regular physical exercise as determined by the patient's own primary care provider or other treating provider.
Who cannot join
- prior history of dementia, neurologic illness (other than stroke), or substance abuse;
- significant visual or hearing disabilities (e.g., neglect, uncorrected visual or hearing loss) that interfere with testing;
- per self-report uncontrolled cardiorespiratory and/or metabolic disorders incompatible with exercise.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of California Berkeley
Berkeley, California, 94720
California State University East Bay
Hayward, California, 94542
University of San Francisco
San Francisco, California, 94118
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Exercising Language: Behavioral and Neurophysiological Changes After High-intensity Exercise Training in Post-stroke Aphasia
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. The main questions it aims to answer are:
- Is it feasible for stroke survivors with aphasia to participate in a long in-person physical exercise program?
- Does participation in a physical exercise program lead to physical fitness, cognitive, language and/or psychological changes?
Participants can take part in two different physical exercise interventions:
- Low intensity intervention (control intervention);
- High-intensity physical exercise intervention (target intervention).
- Conditions
- Aphasia, Acquired, Aphasia, Aphasia, Fluent, Aphasia Non Fluent
- Being tested
- Low-intensity physical exercise, High-intensity physical exercise
- Keywords
- aphasia, physical exercise, high intensity interval training, cognition, physical fitness, balance
- Medical subject headings
- Aphasia, Aphasia, Wernicke, Aphasia, Broca, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity physical exerciseBehavioural
As an active control intervention, a low-intensity non-aerobic exercise program was selected that mirrors more closely the standard-of-care physical therapy currently provided to stroke patients. This control intervention will offer the same level of participant involvement and type of exercises, but without the intensity element, i.e., it will not incorporate the cardiovascular and the strengthening components.
High-intensity physical exerciseBehavioural
We have developed a new exercise program specifically designed for individuals with post-stroke aphasia, Aphasia Physical EXercise (APEX), to provide a safe, stroke- and aphasia-friendly physical exercise intervention to achieve optimal physical fitness and cognitive/language gains. This intervention, based on published research and clinical practice recommendations, is a high-intensity interval training full-body workout optimized to accommodate the range of motor abilities and general deconditioning observed in stroke survivors.
| Study group | Role | What they receive |
|---|---|---|
| Low-intensity physical exercise | Active comparator | The participants will participate in a low-intensity non-aerobic exercise program for 2 weeks. Receives: Behavioral: Low-intensity physical exercise |
| High-intensity physical exercise | Experimental | 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. Receives: Behavioral: High-intensity physical exercise |
| High-intensity physical exercise - remote | Experimental | 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. Receives: Behavioral: High-intensity physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the Western Aphasia Battery (WAB) - Aphasia Quotient
The Aphasia Quotient from the Western Aphasia Battery (a standardized language test) measures overall severity of language impairment in aphasia and ranges from 0 to 100, with lower scores indicative of more severe aphasia.
Measured: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Secondary outcomes (7)
Changes in Maximal Aerobic Capacity
This is a measure of cardiorespiratory and metabolic fitness. Maximal Aerobic Capacity (VO2 Max) is the ability of the body to utilize oxygen to produce energy and is measured via a graded exercise test until volitional fatigue, while measuring consumption of oxygen with a computerized metabolic system. Typically measured on a treadmill, VO2 Max has also been found to be accurately and safely measured in stroke survivors on a recumbent stepper, which will be used in this study. A good VO2max varies greatly depending on age, and for older participants is typically between 30-40 ml/kg/min (higher values indicate greater fitness).
Measured: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Attendance
Total number of physical exercise classes attended during the intervention.
Measured: After the intervention (3rd week for the control intervention and 9th week for the experimental intervention)
Change on the 30-second chair stands
The number of full stands from a seated position that can be completed in 30 seconds with arms folded across the chest.
Measured: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Change on the 2-minute Step Test
The number of knee raises completed in 2 minutes, raising each knee to a point midway between the patella (kneecap) and iliac crest (top hip bone).
Measured: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Change on the Timed Up-and-Go Test
The number of seconds it takes to get up from a seated position, walk 3 m, turn, and return to a seated position.
Measured: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Change on the Functional Reach Test
The number of inches reached forward with each arm with feet flat on the floor at hip width.
Measured: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Change in Gait Speed
The speed in meters per second for the middle 6 m of the 10 m walkway.
Measured: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start11 Dec 2023
- Primary completion12 Sep 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphasia, AcquiredStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- As this is a feasibility study, participants can choose to participate in just one or both types of physical exercise interventions.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, University of San Francisco, California State University, East Bay
- Responsible party
- Principal investigator, Maria Ivanova, University of California, Berkeley
- Investigators
- Maria Ivanova, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185023
- Sponsor's protocol ID
- 056427-002
- Status last verified
- Feb 2026
- First submitted
- 14 Dec 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercising Language: Behavioral and Neurophysiological Changes After High-intensity Exercise Training in Post-stroke Aphasia
- ClinicalTrials.gov ID
- NCT06185023
- Acronym / sponsor ID
- 056427-002
- Conditions
- Aphasia, Acquired, Aphasia, Aphasia, Fluent, Aphasia Non Fluent
- Keywords
- aphasia, physical exercise, high intensity interval training, cognition, physical fitness, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- University of California, San Francisco, University of San Francisco, California State University, East Bay
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 29 Dec 2023 (actual)
- 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 goal of this clinical trial is to establish the feasibility and fidelity of a high-intensity exercise program for individuals with post-stroke aphasia. The main questions it aims to answer are:
- Is it feasible for stroke survivors with aphasia to participate in a long in-person physical exercise program?
- Does participation in a physical exercise program lead to physical fitness, cognitive, language and/or psychological changes?
Participants can take part in two different physical exercise interventions:
- Low intensity intervention (control intervention);
- High-intensity physical exercise intervention (target intervention).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- As this is a feasibility study, participants can choose to participate in just one or both types of physical exercise interventions.
| Arm | Type | Receives |
|---|---|---|
| Low-intensity physical exercise | Active comparator | Behavioral: Low-intensity physical exerciseThe participants will participate in a low-intensity non-aerobic exercise program for 2 weeks. |
| High-intensity physical exercise | Experimental | Behavioral: High-intensity physical exerciseThe 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. |
| High-intensity physical exercise - remote | Experimental | Behavioral: High-intensity physical exerciseThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- aphasia following single or multiple ischemic or hemorrhagic stroke;
- at least 6 months from the last stroke;
- proficient in English before the stroke;
- at least 8 years of education;
- between the ages of 18 and 80;
Key exclusion criteria (3 listed)
- prior history of dementia, neurologic illness (other than stroke), or substance abuse;
- significant visual or hearing disabilities (e.g., neglect, uncorrected visual or hearing loss) that interfere with testing;
- per self-report uncontrolled cardiorespiratory and/or metabolic disorders incompatible with exercise.
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 |
|---|---|---|
| Low-intensity physical exerciseAs an active control intervention, a low-intensity non-aerobic exercise program was selected that mirrors more closely the standard-of-care physical therapy currently provided to stroke patients. This control intervention will offer the same level of participant involvement and type of exercises, but without the intensity element, i.e., it will not incorporate the cardiovascular and the strengthening components. | Behavioural | Low-intensity physical exercise |
| High-intensity physical exerciseWe have developed a new exercise program specifically designed for individuals with post-stroke aphasia, Aphasia Physical EXercise (APEX), to provide a safe, stroke- and aphasia-friendly physical exercise intervention to achieve optimal physical fitness and cognitive/language gains. This intervention, based on published research and clinical practice recommendations, is a high-intensity interval training full-body workout optimized to accommodate the range of motor abilities and general deconditioning observed in stroke survivors. | Behavioural | High-intensity physical exercise, High-intensity physical exercise - remote |
Primary outcome
Change on the Western Aphasia Battery (WAB) - Aphasia Quotient
Time frame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
The Aphasia Quotient from the Western Aphasia Battery (a standardized language test) measures overall severity of language impairment in aphasia and ranges from 0 to 100, with lower scores indicative of more severe aphasia.
7 secondary outcomes
Changes in Maximal Aerobic Capacity
Time frame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Attendance
Time frame: After the intervention (3rd week for the control intervention and 9th week for the experimental intervention)
Change on the 30-second chair stands
Time frame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Change on the 2-minute Step Test
Time frame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Change on the Timed Up-and-Go Test
Time frame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Change on the Functional Reach Test
Time frame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Change in Gait Speed
Time frame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
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 17 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Maria Ivanova, PhD principal investigator
University of California, Berkeley
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity physical exercise and High-intensity physical exercise in people with Aphasia, Acquired and Aphasia, run by University of California, Berkeley at 4 sites 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 7 inclusion and 3 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 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Change on the Western Aphasia Battery (WAB) - Aphasia Quotient (time frame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)). 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 17 Feb 2026.