- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07429526
Does Aerobic Exercise Affect Memory and Fatigue After Acquired Brain Injury?
Does Aerobic Exercise Affect Memory, Attention, Working Memory, and Fatigue After Acquired Brain Injury? A Single-Blinded, Randomized Controlled Pilot Study
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Stockholm, Sweden, 14186
- Danderyds Sjukhus, Rehabiliteringsmedicinska Universitets Kliniken Stockholm
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Aerobic exercise
30 min of AE, 3-4 times/week for 8 weeks,
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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.
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No Intervention: Control
rehabilitation according to rehabilitation program, not including aerobic training
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
From enrolment to the end of participation at 8 weeks and at a 3 month follow up
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|
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. |
From enrolment to the end of participation at 8 weeks and at a 3 month follow uo
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Attention
Time Frame: From enrolment to the end of participation at 8 weeks and at a 3 month follow up
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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
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fatigue
Time Frame: From enrolment to the end of participation at 8 weeks and at a 3 month follow up
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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
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From enrolment to the end of participation at 8 weeks and at a 3 month follow up
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Attention
Time Frame: From enrolment to the end of participation at 8 weeks and at a 3 month follow up
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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
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Attention
Time Frame: From enrolment to the end of participation at 8 weeks and at a 3 month follow up
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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
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Stroke
- Fatigue
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
Other Study ID Numbers
- 2012/320/31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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