StrokeNCT07429526
Does Aerobic Exercise Affect Memory and Fatigue After Acquired Brain Injury?
A study testing exercise in people with Stroke and TBI, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
Acquired brain injury can affect cognition and cause fatigue. Aerobic exercise has been linked to improved cognition in the general population. This is thought to occur through boosting neuroplasticity, that is to say the brain's ability to change and adapt. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2013to 1 Jun 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - First stroke/TBI with CT/MRI verified injury, (moderate to severe brain injury)
- Age 18-65 years
- at least 3 months after injury
- Fluent in Swedish Selection criteria
- Cognition:
- one standard deviation (SD) below age adjusted normal in at least one of the following tests: verbal memory, visual memory, working memory or attention
- be able to follow instructions during neuropsychological (NP) testing.
- be able to reach 60-80% of estimated maximal heart rate (HRmax= 220-age) during aerobic testing and training
Who cannot join
- - Severe heart disease
- Cognitive defects, not due to the actual stroke or TBI
- Moderate depression/anxiety, defined as >10 respectively on HADS
- Severe aphasia
- Not fulfilling criterias for MRI (such as pregnancy, having metal parts implanted in the body, afraid of cramped spaces)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Danderyds Sjukhus, Rehabiliteringsmedicinska Universitets Kliniken Stockholm
Stockholm, 14186
About this study
Official title: Does Aerobic Exercise Affect Memory, Attention, Working Memory, and Fatigue After Acquired Brain Injury? A Single-Blinded, Randomized Controlled Pilot Study
Acquired brain injury can affect cognition and cause fatigue. Aerobic exercise has been linked to improved cognition in the general population. This is thought to occur through boosting neuroplasticity, that is to say the brain's ability to change and adapt. Investigators explored the effects of aerobic exercise after acquired brain injury and investigated if any changes on the brain could be detected. This was done through an 8-week period of 30 min of aerobic exercise, 3-4 times a week for a group of 6 participants compared with 6 participants that did their usual training. Magnetic resonance imaging was used to detect any changes on the brain.
Read the detailed description
The objective is to study the effects of aerobic exercise on cognitive function, fatigue and neuroplasticity after stroke or traumatic brain injury with a randomized controlled pilot study. Subjects were patients aged 16-65 years with moderate to severe stroke or traumatic brain injury at least 3 months post injury. The intervention group participated in 30 min of aerobic exercise 3-4 times/week for 8 weeks during their outpatient rehabilitation. The control group received routine physical therapy. In addition, both groups received rehabilitation according to their rehabilitation plan. Neuropsychological and endurance testing was performed before and after the intervention and at a 3 month follow up. Magnetic resonance imaging was performed before and after the intervention.
- Being tested
- exercise
- Keywords
- stroke, TBI, aerobic training, cognition, fatigue, MRI
- Medical subject headings
- Stroke, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
30 min of AE, 3-4 times/week for 8 weeks, included in a rehabilitation program based on current guidelines and patient's individual needs.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | 30 min of AE, 3-4 times/week for 8 weeks, Receives: Other: exercise |
| Control | No intervention | rehabilitation according to rehabilitation program, not including aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory
Memory, measured by the following test:
Rey Auditory Verbal Learning Test (RAVLT), a test of verbal learning and long-term memory (25). The RAVL Test consists of a 15 noun-word list (list A) that is read to the participants. After the presentation of list A, the participant is requested to recall as many words as possible. The procedure is repeated 5 times, and after each trial recall is recorded and all five recall trials are summed into one score (= immediate recall score). After 5 presentations of list A, an interference-list of 15 other nouns (list B) are read and the participants are asked to recall as many words as possible. Immediately after the recall of list B, the participants are again asked to recall list A. Delayed recall of list A is measured 30 min after the immediate recall (= delayed recall score). The higher the value the better result.
Measured: From enrolment to the end of participation at 8 weeks and at a 3 month follow up
Executive functions
Executive functions measured by the following test:
Kaplan executive function system (D-KEFS) Color Word Test, measures the ability to inhibit automized verbal responses and the ability to use cognitive shifting. The test has four conditions: 1) naming the colors of squares (red, blue or green, 2) reading color words printed in black, 3) naming the printed color of the color words red, blue, or green printed in a different color, which means inhibition of an over-learned function of reading the word; 4) repeatedly switching between a) naming the printed color of the color words red, blue, or green and b) reading the words as quickly as possible. In this condition the person needs to keep track of clues that indicate rule change. Sub tests 1 and 2 are contrast tests and used for comparison between the sub tests 3 and 4 i.e. the more complex tasks. The faster the time, the better which give that lower values represent better results.
Measured: From enrolment to the end of participation at 8 weeks and at a 3 month follow uo
Attention
Attention measured by the following tests:
Paced Auditory Serial Addition Test (PASAT) Measures auditive processing speed, attention, and working memory. The test consists of 60 digits from 1-9 presented at a standardized pace of 2.4 seconds between each digit. The task is to sum each digit with the previously presented one before the next digit is presented. The test was presented according to the manual. The maximum score is 60. This test was also used to measure cognitive fatigability as declining performance in terms of an increased number of incorrect responses on the PASAT. The responses were divided into five sections of 12 numbers each, where the number of correct answers in the first section was subtracted from the number of correct answers in the last section. Fatigability was defined as a lower score at the end of the test compared to the beginning, giving a negative value.
Measured: From enrolment to the end of participation at 8 weeks and at a 3 month follow up
fatigue
Fatigability was defined as a lower score at the end of the Paced Auditory Serial Addition Test (PASAT) test compared to the beginning, giving a negative value
Measured: From enrolment to the end of participation at 8 weeks and at a 3 month follow up
Attention
Attention measured by the following test:
Ruff 2 \& 7 Selective Attention Test (Ruff 2 \& 7)
Measures visual automatic detection speed and accuracy, and controlled search speed and accuracy. The test consists of twenty, 15-second trials, where the subject must identify and cancel the target digits 2 and 7 among distractors. The distractors consist of letters (automatic selective attention) and other digits (controlled selective attention) for ten trials each. Speed of attention is measured as the total number of correctly identified targets. The accuracy calculated as the total number of correct targets divided with the (total number of correct targets + total number of errors) multiplied with 100 according to the manual. A higher score equals better performance.
Measured: From enrolment to the end of participation at 8 weeks and at a 3 month follow up
Attention
Attention measured by the following test:
WAIS-IV Digit Span, measures verbal attention span and working memory. The participant is asked to repeat a series of digits in the same (attention span) or reverse order (working memory). The length starts with 2 digits and ends with 9 digits, two trials per length. After two consecutive errors at the same span length the test is aborted. The test was presented according to the manual. The higher the value the better results (27).
Measured: From enrolment to the end of participation at 8 weeks and at a 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Nov 2013
- Primary completion1 Sep 2022
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- A SINGLE BLINDED, RANDOMIZED CONTROLLED PILOT STUDY.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eyglo Ingolfsdottir, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429526
- Sponsor's protocol ID
- 2012/320/31
- Status last verified
- Feb 2026
- First submitted
- 19 Nov 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ingolfsdottir E, Bergfeldt U, Berthold Lindstedt M, Bergfeldt L, Li TQ, Jonsson T, Moller MC. Does aerobic exercise affect memory, attention, working memory, and fatigue after acquired brain injury? A single-blinded, randomized controlled pilot study. J Rehabil Med. 2026 Apr 16;58:jrm44745. doi: 10.2340/jrm.v58.44745.
PubMed 41988967
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Aerobic Exercise Affect Memory, Attention, Working Memory, and Fatigue After Acquired Brain Injury? A Single-Blinded, Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07429526
- Acronym / sponsor ID
- 2012/320/31
- Keywords
- stroke, TBI, aerobic training, cognition, fatigue, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 24 Feb 2026 (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.
Acquired brain injury can affect cognition and cause fatigue. Aerobic exercise has been linked to improved cognition in the general population. This is thought to occur through boosting neuroplasticity, that is to say the brain's ability to change and adapt. Investigators explored the effects of aerobic exercise after acquired brain injury and investigated if any changes on the brain could be detected. This was done through an 8-week period of 30 min of aerobic exercise, 3-4 times a week for a group of 6 participants compared with 6 participants that did their usual training. Magnetic resonance imaging was used to detect any changes on the brain.
Detailed description
The objective is to study the effects of aerobic exercise on cognitive function, fatigue and neuroplasticity after stroke or traumatic brain injury with a randomized controlled pilot study. Subjects were patients aged 16-65 years with moderate to severe stroke or traumatic brain injury at least 3 months post injury. The intervention group participated in 30 min of aerobic exercise 3-4 times/week for 8 weeks during their outpatient rehabilitation. The control group received routine physical therapy. In addition, both groups received rehabilitation according to their rehabilitation plan. Neuropsychological and endurance testing was performed before and after the intervention and at a 3 month follow up. Magnetic resonance imaging was performed before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A SINGLE BLINDED, RANDOMIZED CONTROLLED PILOT STUDY.
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Other: exercise30 min of AE, 3-4 times/week for 8 weeks, |
| Control | No intervention | –rehabilitation according to rehabilitation program, not including aerobic training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- - First stroke/TBI with CT/MRI verified injury, (moderate to severe brain injury)
- Age 18-65 years
- at least 3 months after injury
- Fluent in Swedish Selection criteria
- Cognition:
Key exclusion criteria (5 listed)
- - Severe heart disease
- Cognitive defects, not due to the actual stroke or TBI
- Moderate depression/anxiety, defined as >10 respectively on HADS
- Severe aphasia
- Not fulfilling criterias for MRI (such as pregnancy, having metal parts implanted in the body, afraid of cramped spaces)
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 |
|---|---|---|
| exercise30 min of AE, 3-4 times/week for 8 weeks, included in a rehabilitation program based on current guidelines and patient's individual needs. | Other | Aerobic exercise |
Primary outcome
Memory
Time frame: From enrolment to the end of participation at 8 weeks and at a 3 month follow up
Memory, measured by the following test: Rey Auditory Verbal Learning Test (RAVLT), a test of verbal learning and long-term memory (25). The RAVL Test consists of a 15 noun-word list (list A) that is read to the participants. After the presentation of list A, the participant is requested to recall as many words as possible. The procedure is repeated 5 times, and after each trial recall is recorded and all five recall trials are summed into one score (= immediate recall score). After 5 presentations of list A, an interference-list of 15 other nouns (list B) are read and the participants are asked to recall as many words as possible. Immediately after the recall of list B, the participants are again asked to recall list A. Delayed recall of list A is measured 30 min after the immediate recall (= delayed recall score). The higher the value the better result.
Executive functions
Time frame: From enrolment to the end of participation at 8 weeks and at a 3 month follow uo
Executive functions measured by the following test: Kaplan executive function system (D-KEFS) Color Word Test, measures the ability to inhibit automized verbal responses and the ability to use cognitive shifting. The test has four conditions: 1) naming the colors of squares (red, blue or green, 2) reading color words printed in black, 3) naming the printed color of the color words red, blue, or green printed in a different color, which means inhibition of an over-learned function of reading the word; 4) repeatedly switching between a) naming the printed color of the color words red, blue, or green and b) reading the words as quickly as possible. In this condition the person needs to keep track of clues that indicate rule change. Sub tests 1 and 2 are contrast tests and used for comparison between the sub tests 3 and 4 i.e. the more complex tasks. The faster the time, the better which give that lower values represent better results.
Attention
Time frame: From enrolment to the end of participation at 8 weeks and at a 3 month follow up
Attention measured by the following tests: Paced Auditory Serial Addition Test (PASAT) Measures auditive processing speed, attention, and working memory. The test consists of 60 digits from 1-9 presented at a standardized pace of 2.4 seconds between each digit. The task is to sum each digit with the previously presented one before the next digit is presented. The test was presented according to the manual. The maximum score is 60. This test was also used to measure cognitive fatigability as declining performance in terms of an increased number of incorrect responses on the PASAT. The responses were divided into five sections of 12 numbers each, where the number of correct answers in the first section was subtracted from the number of correct answers in the last section. Fatigability was defined as a lower score at the end of the test compared to the beginning, giving a negative value.
fatigue
Time frame: From enrolment to the end of participation at 8 weeks and at a 3 month follow up
Fatigability was defined as a lower score at the end of the Paced Auditory Serial Addition Test (PASAT) test compared to the beginning, giving a negative value
Attention
Time frame: From enrolment to the end of participation at 8 weeks and at a 3 month follow up
Attention measured by the following test: Ruff 2 \& 7 Selective Attention Test (Ruff 2 \& 7) Measures visual automatic detection speed and accuracy, and controlled search speed and accuracy. The test consists of twenty, 15-second trials, where the subject must identify and cancel the target digits 2 and 7 among distractors. The distractors consist of letters (automatic selective attention) and other digits (controlled selective attention) for ten trials each. Speed of attention is measured as the total number of correctly identified targets. The accuracy calculated as the total number of correct targets divided with the (total number of correct targets + total number of errors) multiplied with 100 according to the manual. A higher score equals better performance.
Attention
Time frame: From enrolment to the end of participation at 8 weeks and at a 3 month follow up
Attention measured by the following test: WAIS-IV Digit Span, measures verbal attention span and working memory. The participant is asked to repeat a series of digits in the same (attention span) or reverse order (working memory). The length starts with 2 digits and ends with 9 digits, two trials per length. After two consecutive errors at the same span length the test is aborted. The test was presented according to the manual. The higher the value the better results (27).
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 24 Feb 2026.
- Derived from this study: PubMed 41988967Ingolfsdottir E, Bergfeldt U, Berthold Lindstedt M, Bergfeldt L, Li TQ, Jonsson T, Moller MC. Does aerobic exercise affect memory, attention, working memory, and fatigue after acquired brain injury? A single-blinded, randomized controlled pilot study. J Rehabil Med. 2026 Apr 16;58:jrm44745. doi: 10.2340/jrm.v58.44745.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Stroke and TBI, run by Danderyd Hospital at 1 site in Sweden.
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 5 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 24 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 1 site in Sweden. 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?
Memory (time frame: From enrolment to the end of participation at 8 weeks and at a 3 month follow up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07429526, which also lists 1 linked publication.
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 24 Feb 2026.