Aphasia, AcquiredAPEXNCT07281313
Aphasia Physical EXercise Study: Randomized Trial
A study testing High-intensity physical exercise and Low-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 evaluate the effects of a high-intensity exercise program on recovery in individuals with post-stroke aphasia. The high-intensity exercise program has been specifically designed for individuals with post-stroke aphasia and includes an interval training full-body workout, which can… 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?
- High-intensity physical exercise and Low-intensity physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Dec 2025to 1 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 ischemic or hemorrhagic stroke
- Aphasia as determined by a standardized language test (Western Aphasia Battery Aphasia Quotient < 93.8 at study intake)
- 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 patients' own primary care provider or other treating provider.
Who cannot join
- Prior history of dementia, neurologic illness (other than stroke), or recent (last 3 years) substance abuse
- Significant visual or hearing disabilities (e.g., neglect, uncorrected visual or hearing loss) that interfere with testing
- Self-report uncontrolled cardiorespiratory and/or metabolic disorders incompatible with exercise
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of California, Berkeley
Berkeley, California, 94720
Maria Ivanova, PhD, 650-390-7572, ivanova@berkeley.edu
- Recruiting
California State University, East Bay
Hayward, California, 94542
Michelle Gravier, PhD, michelle.gravier@csueastbay.edu
- Recruiting
University of San Francisco
San Francisco, California, 94118
Christian J Thompson, Ph.D., cjthompson@usfca.edu
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Cathra Halabi, MD, Cathra.Halabi@ucsf.edu
About this study
Official title: High-intensity Exercise in Stroke Recovery: 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 aphasia. The high-intensity exercise program has been specifically designed for individuals with post-stroke aphasia and includes an interval training full-body workout, which can increase cardiovascular fitness, improve muscle strength and motor performance, and maximize cognitive and language gains. The main question this study aims to answer is:
- Does participation in a high-intensity exercise program lead to changes in physical health, language, cognitive, motor recovery, psychological and/or psychosocial domains?
Read more
Participants will be randomly assigned to either a high-intensity exercise program (target intervention) or a low-intensity exercise program (control intervention) delivered over 12-weeks in a group setting.
Outcome measures will be collected once immediately after the intervention period and once during the following 12-week maintenance period to capture short- and long-term effects of the exercise program.
- Conditions
- Aphasia, Acquired, Aphasia, Aphasia, Fluent, Aphasia, Non-fluent, Aphasia Following Cerebral Infarction, Aphasia Following Nontraumatic Intracerebral Hemorrhage
- Being tested
- High-intensity physical exercise, Low-intensity physical exercise
- Keywords
- aphasia, physical exercise, high intensity interval training, cognition, physical fitness, balance, stroke, language
- Medical subject headings
- Aphasia, Aphasia, Wernicke, Aphasia, Broca, Motor Activity, Stroke, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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 interaction, but without the intensity element, i.e., it will not incorporate the cardiovascular and the strengthening components.
| Study group | Role | What they receive |
|---|---|---|
| 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 12 weeks. Receives: Behavioral: High-intensity physical exercise |
| Low-intensity physical exercise | Active comparator | The participants will participate in a low-intensity non-aerobic exercise program for 12 weeks. Receives: Behavioral: Low-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: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
Secondary outcomes (11)
Change on the WAB subtest scores
The subtests from the Western Aphasia Battery (a standardized language test) measure different language capacities. Specifically, we will look at Spontaneous Speech, Fluency, Auditory Verbal Comprehension, Repetition, Naming and Word Finding subtest scores.
Measured: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
Change on the Curtiss-Yamada Comprehensive Language Evaluation - Revised (CYCLE-R)
A sentence-to-picture matching tasks that evaluates comprehension of sentences of varying complexity. The scores range from 0 to 100%, with higher scores indicative of better comprehension abilities.
Measured: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
Changes on Category and Letter Verbal Fluency tasks
Test of word retrieval and executive control abilities such as updating, shifting, and inhibiting. Participants are asked to name as many items as possible in 1 minute for a given category (e.g., clothes) and for a given letter (e.g., "s").
Measured: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
Change on the Philadelphia Naming Test (PNT)
Aphasia naming test to assess word retrieval abilities. The score ranges from 0 to 100, with a higher score indicating greater naming ability.
Measured: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
Changes on the California Cognitive Assessment Battery (CCAB)
This is a computerized assessment battery of cognitive tasks that provides a comprehensive assessment of different cognitive domains. These tasks include computerized version of standard cognitive tasks such as Trail making test, Stroop test, Digit and Spatial Span tasks, Verbal learning tasks. These tasks will require participants to memorize lists of words, digits, describe pictures, and draw on the tablet. Participant's verbal and pointing responses will be recorded. The following tasks will be used: BAVLT Encoding, Digit Span Forward, Digit Span Reverse, Picture Matching, Spatial Span, Finger Tapping, BAVLT Delayed Recall, Continuous Picture Naming, Picture Description, Simple Reaction Time, Trails A, Trails B, Stroop, Design Fluency, Picture Description Delayed Recall, Verbal Fluency.
Measured: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
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 VO2 Max varies greatly depending on age, and for older participants is typically between 30-40ml/kg/min (higher values indicate greater fitness).
Measured: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention.
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: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the 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: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
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: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
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: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
Change in Gait Speed
The speed in meters per second for the middle 6 m of the 10 m walkway.
Measured: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Dec 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion1 Mar 2030 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to the low intensity intervention (control intervention) or the high-intensity physical exercise intervention (target intervention).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, California State University, East Bay, University of San Francisco, National Institute on Deafness and Other Communication Disorders (NIDCD)
- 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
- NCT07281313
- Sponsor's protocol ID
- 20243771
- Other IDs
- R01DC022663
- Acronym
- APEX
- Status last verified
- Mar 2026
- First submitted
- 25 Nov 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Exercise in Stroke Recovery: Randomized Trial
- ClinicalTrials.gov ID
- NCT07281313
- Acronym / sponsor ID
- APEX / 20243771
- Conditions
- Aphasia, Acquired, Aphasia, Aphasia, Fluent, Aphasia, Non-fluent, Aphasia Following Cerebral Infarction, Aphasia Following Nontraumatic Intracerebral Hemorrhage
- Keywords
- aphasia, physical exercise, high intensity interval training, cognition, physical fitness, balance, stroke, language
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- University of California, San Francisco, California State University, East Bay, University of San Francisco, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 15 Dec 2025 (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 evaluate the effects of a high-intensity exercise program on recovery in individuals with post-stroke aphasia. The high-intensity exercise program has been specifically designed for individuals with post-stroke aphasia and includes an interval training full-body workout, which can increase cardiovascular fitness, improve muscle strength and motor performance, and maximize cognitive and language gains. The main question this study aims to answer is:
- Does participation in a high-intensity exercise program lead to changes in physical health, language, cognitive, motor recovery, psychological and/or psychosocial domains?
Participants will be randomly assigned to either a high-intensity exercise program (target intervention) or a low-intensity exercise program (control intervention) delivered over 12-weeks in a group setting.
Outcome measures will be collected once immediately after the intervention period and once during the following 12-week maintenance period to capture short- and long-term effects of the exercise program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to the low intensity intervention (control intervention) or the high-intensity physical exercise intervention (target intervention).
| Arm | Type | Receives |
|---|---|---|
| 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 12 weeks. |
| Low-intensity physical exercise | Active comparator | Behavioral: Low-intensity physical exerciseThe participants will participate in a low-intensity non-aerobic exercise program for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aphasia following ischemic or hemorrhagic stroke
- Aphasia as determined by a standardized language test (Western Aphasia Battery Aphasia Quotient < 93.8 at study intake)
- At least 6 months from the last stroke
- Proficient in English before the stroke
- At least 8 years of education
Key exclusion criteria (3 listed)
- Prior history of dementia, neurologic illness (other than stroke), or recent (last 3 years) substance abuse
- Significant visual or hearing disabilities (e.g., neglect, uncorrected visual or hearing loss) that interfere with testing
- 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 |
|---|---|---|
| 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 |
| 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 interaction, but without the intensity element, i.e., it will not incorporate the cardiovascular and the strengthening components. | Behavioural | Low-intensity physical exercise |
Primary outcome
Change on the Western Aphasia Battery (WAB) - Aphasia Quotient
Time frame: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
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.
11 secondary outcomes
Change on the WAB subtest scores
Time frame: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
Change on the Curtiss-Yamada Comprehensive Language Evaluation - Revised (CYCLE-R)
Time frame: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
Changes on Category and Letter Verbal Fluency tasks
Time frame: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
Change on the Philadelphia Naming Test (PNT)
Time frame: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
Changes on the California Cognitive Assessment Battery (CCAB)
Time frame: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
Changes in Maximal Aerobic Capacity
Time frame: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention.
Change on the 2-minute Step Test
Time frame: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
Change on the 30-second chair stands
Time frame: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
Change on the Timed Up-and-Go Test
Time frame: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
Change on the Functional Reach Test
Time frame: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
Change in Gait Speed
Time frame: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
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 High-intensity physical exercise and Low-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 8 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: looking for participants now, as of the sponsor's last update on 19 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Ivanova, PhD (650-390-7572, ivanova@berkeley.edu), or a site near the patient. 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: (T1) Baseline: at the start of the study; (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention; (T4) Follow-up: 3 months after the conclusion of the intervention.). 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 19 Mar 2026.