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Completed

NCT Number: NCT07429526

Does Aerobic Exercise Affect Memory and Fatigue After Acquired Brain Injury?

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danderyds Sjukhus, Rehabiliteringsmedicinska Universitets Kliniken Stockholm

Stockholm, 14186, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - 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

Exclusion criteria

  • - 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)

Treatment and study plan

Exercise

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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).

Sponsors and collaborators

Lead sponsor

Danderyd Hospital

Other

Registry information

Official study title

Does Aerobic Exercise Affect Memory, Attention, Working Memory, and Fatigue After Acquired Brain Injury? A Single-Blinded, Randomized Controlled Pilot Study

Important dates

Study start
2013
Primary completion
2022
Study completion
2024
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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