NCT07429526

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

8.8 years

First QC Date

November 19, 2025

Last Update Submit

February 17, 2026

Conditions

Keywords

strokeTBIaerobic trainingcognitionfatigueMRI

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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

    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.

    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).

    From enrolment to the end of participation at 8 weeks and at a 3 month follow up

Study Arms (2)

Aerobic exercise

EXPERIMENTAL

30 min of AE, 3-4 times/week for 8 weeks,

Other: exercise

Control

NO INTERVENTION

rehabilitation according to rehabilitation program, not including aerobic training

Interventions

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.

Aerobic exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danderyds Sjukhus, Rehabiliteringsmedicinska Universitets Kliniken Stockholm

Stockholm, 14186, Sweden

Location

MeSH Terms

Conditions

StrokeFatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A SINGLE BLINDED, RANDOMIZED CONTROLLED PILOT STUDY.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

November 19, 2025

First Posted

February 24, 2026

Study Start

November 1, 2013

Primary Completion

September 1, 2022

Study Completion

June 1, 2024

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations