Aphasia Physical EXercise Study: Randomized Trial
NCT07281313, Not applicable, Recruiting, University of California, Berkeley
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Aphasia Physical EXercise Study: Randomized Trial | ClinicalTrials.gov |
| NCT number | NCT07281313 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 120 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of California, Berkeley | ClinicalTrials.gov |
| Conditions | Aphasia, Acquired, Aphasia, Aphasia, Fluent, Aphasia, Non-fluent, Aphasia Following Cerebral Infarction, Aphasia Following Nontraumatic Intracerebral Hemorrhage | ClinicalTrials.gov |
| Interventions | High-intensity physical exercise, Low-intensity physical exercise | ClinicalTrials.gov |
| First posted | 2025-12-15 | ClinicalTrials.gov |
| Last updated | 2026-03-19 | ClinicalTrials.gov |
Registered outcomes 24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change on the Western Aphasia Battery (WAB) - Aphasia Quotient | (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. | ClinicalTrials.gov |
| Secondary | Change on the WAB subtest scores | (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 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. | ClinicalTrials.gov |
| Secondary | Change on the Curtiss-Yamada Comprehensive Language Evaluation - Revised (CYCLE-R) | (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. | 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. | ClinicalTrials.gov |
| Secondary | Changes on Category and Letter Verbal Fluency tasks | (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. | 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"). | ClinicalTrials.gov |
| Secondary | Change on the Philadelphia Naming Test (PNT) | (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. | Aphasia naming test to assess word retrieval abilities. The score ranges from 0 to 100, with a higher score indicating greater naming ability. | ClinicalTrials.gov |
| Secondary | Changes on the California Cognitive Assessment Battery (CCAB) | (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. | 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. | ClinicalTrials.gov |
| Secondary | Changes in Maximal Aerobic Capacity | (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. | 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). | ClinicalTrials.gov |
| Secondary | Change on the 2-minute Step Test | (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 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) | ClinicalTrials.gov |
| Secondary | Change on the 30-second chair stands | (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 number of full stands from a seated position that can be completed in 30 seconds with arms folded across the chest. | ClinicalTrials.gov |
| Secondary | Change on the Timed Up-and-Go Test | (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 number of seconds it takes to get up from a seated position, walk 3 m, turn, and return to a seated position. | ClinicalTrials.gov |
| Secondary | Change on the Functional Reach Test | (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 number of inches reached forward with each arm with feet flat on the floor at hip width. | ClinicalTrials.gov |
| Secondary | Change in Gait Speed | (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 speed in meters per second for the middle 6 m of the 10 m walkway. | ClinicalTrials.gov |
| Other | Changes on the Narrative Discourse Sample | (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. | Analysis of discourse samples elicited using the WAB-R picture description, the Cat rescue story and the Cinderella story retell, narrative tasks commonly used in aphasia research. | ClinicalTrials.gov |
| Other | Changes on the Functional Gait Assessment (FGA) | (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. | A multi-component assessment of postural stability during walking and ability to perform additional motor tasks while walking. | ClinicalTrials.gov |
| Other | Change in Center for Epidemiological Studies Depression Scale (CES-D) | (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 20-item self-rating questionnaire evaluates perceived mood and level of functioning within the past seven days. The scores range from 0-60. A score equal to or above 16 indicates a person at risk for clinical depression. | ClinicalTrials.gov |
| Other | Changes on the General Anxiety Disorder scale (GAD-7) | (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 7-item self-report scale is used to identify anxiety based on problems experienced in the last two weeks. The scores range from 0-21, with higher scores indicative of more pronounced anxiety symptoms. | ClinicalTrials.gov |
| Other | Changes on the Pittsburgh Sleep Quality Index (PSQI) | (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 self-rating scale used to measure the quality and patterns of sleep. It differentiates "poor" from "good" sleep by measuring seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over the last month. The overall score ranges from 0-21, with higher scores indicative of more acute sleep disturbances. | ClinicalTrials.gov |
| Other | Changes on the Stroke and Aphasia Quality of Life Scale - 39 (SAQOL-39) | (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. | This questionnaire is specifically designed to assess quality of life in individuals with stroke and aphasia. The overall quality of life score can range from 1 to 5, with higher values indicating better quality of life and overall well-being. | ClinicalTrials.gov |
| Other | Changes on the Fugl-Meyer Assessment, Upper Extremity portion (FMA-UE) | (T1) Baseline: at the start of the study or (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention. | This is a commonly used outcome measure for assessment of sensorimotor recovery after stroke. We will only use the upper extremity portion of the assessment to supplement other study measures focusing on gait and balance. The FMA-UE assesses movement, coordination, and reflexes associated with the shoulder, elbow, forearm, wrist, and hand and is meant to capture stages of motor recovery after stroke. The FMA-UE consists of 33 items with each item scored on a 3-point ordinal scale (0, 1, or 2), with 0 generally corresponding to no function, 1 to partial function, and 2 to perfect function. The items are summed to provide a final score, ranging from 0-66 points, with lower scores indicative of more pronounced motor impairments of the upper extremity. | ClinicalTrials.gov |
| Other | Change on the Modified Rankin Scale (MRS) | (T1) Baseline: at the start of the study or (T2) Pre-treatment: 1 week prior to the start of the intervention; (T3) Post-treatment: the week immediately following the intervention. | This is a commonly used 7-point rating scale for measuring the degree of overall disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. MRS is a single item, global outcomes rating scale for patients post-stroke. The measure is scored based on a structured interview. It is used to categorize level of functional independence with reference to pre-stroke activities rather than on observed performance of a specific task. The scale ranges from 0 to 6, with higher scores indicative of more severe disability, with 6 indicating that the patient is dead. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01DC022663 | Exercising language: Behavioral and neurophysiological changes after high-intensity exercise training in post-stroke aphasia | IVANOVA, MARIA V. | UNIVERSITY OF CALIFORNIA BERKELEY | NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS | 2025 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 8
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Design Fluency Test | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Simple Reaction Time | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)