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Do Combinatorial Training Lead to Better Cognition and Daily Participation in TBI Persons With Cognitive Impairments

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ClinicalTrials.gov Identifier: NCT04051528
Recruitment Status : Not yet recruiting
First Posted : August 9, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
The objectives of this study are to: (1) determine the effects of combinatorial training (i.e. combinatory of aerobic exercise with cognitive training and guiding training) vs. the sequential training (i.e. a combination of aerobatic exercise with cognitive training) on cognitive function, physical function, and daily function/participation and psychological function in persons with cognitive impairments post Traumatic brain injury (TBI); (2) determine the long-term effects of these two types of interventions on these outcome measures.

Condition or disease Intervention/treatment Phase
Trauma, Brain Cognitive Deficit Procedure: aerobic exercise training Procedure: computerized cognitive training Procedure: guiding training Not Applicable

Detailed Description:

Cognitive deficits and dysfunction in daily participation are common in patients with traumatic brain injury. Previous studies have reported positive effects on cognitive function after computerized cognitive training, aerobic exercise, or a combination of the two, however, the effects are variable and hardly be transferred to enhance daily participation. It is thus still inconclusive that which types of interventions are better for cognitive remediation and daily participation in patients post traumatic brain injury. Several pioneering studies used guided training for patients with brain injury to acquire problem-solving skills, improve life function and promote participation. After the training, the effect lasted for six months. However, due to insufficient research samples, it was inferior in generalizability.

In the present project, the investigators design an innovative combinatorial training that composites of guided training, computerized cognitive training, and aerobic exercise. The investigators expected that this combinatorial training not only improve cognitive ability but also facilitate daily participation in patients with traumatic brain injury. The investigators plan to recruit 50 patients with traumatic brain injury who have cognitive deficits and will assign them randomly into two groups: sequential training group, and combinatorial training group.

There will compare the immediate effects and long-term effects of combinatorial training and combined training (computerized cognitive training plus aerobic exercise) on cognitive function and daily function/participation and psychological function of persons with traumatic brain injury.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Do Combinatorial Training Lead to Better Cognition and Daily Participation in TBI Persons With Cognitive Impairments: Efficacy and Neural Mechanism of Combining Computerized Cognitive Training, Aerobic Exercise and Guided Training
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: combinatorial training group
Combinatorial training group will have the same procedure with the sequential training group in the first 8 sessions. After that the procedure for sessions from 9th to 16th will be 60 minutes of guiding training.
Procedure: aerobic exercise training
The aerobic exercise will first perform 3 minutes of warm-up followed by 25 minutes of resistive aerobic exercise and then 2 minutes cool-down. During the aerobic exercise the target heart rate will be 40 to 70% of maximal heart rate calculated as (208 - 0.7 age). The exercise intensity will be progressed as the participants improve their performance throughout practice. Vital signs and the Borg Perceived Exertion Scale will be monitored and recorded during exercise for each session.

Procedure: computerized cognitive training
The core function of cognitive training will be including attention, recognition, color and shape identification, calculation, visual perception, visuospatial processing and executive function. Participants will perform tasks designed to enhance abovementioned types of cognitive functions. The difficult level of this training program will be adjusted automatically and continuously based on each participant's level of performance. Cognitive training group will use commercialized cognitive based training programs to facilitate several cognitive functions. The core function will be including attention, recognition, color and shape identification, calculation, visual perception, visuospatial processing and executive function. Participants will perform tasks designed to enhance abovementioned types of cognitive functions. The difficult level of this training program will be adjusted automatically and continuously based on each participant's level of performance.

Procedure: guiding training
At the first time in guiding training will focus on introducing the Goal-Plan-Do-Check strategy and identifying initial three goals by the Canadian Occupational Performance Measure. At the second time in guiding training will begin with a review of the Goal-Plan-Do-Check and will apply the Goal-Plan-Do-Check to the first initial goal. Participants will review this goal and plan, describe the execution of the plan (do), and evaluate the execution of the plan (check). After each execution of the plan, the participant will rate his performance using the COPM Performance Scale, producing iterative scores for each activity. The remaining session of guiding sessions will repeat this process, review performance of identified activities, and applying the Goal-Plan-Do-Check strategy to improve performance.

Experimental: sequential training group.
Sequential training group will first undergo aerobic exercise training for 30 minutes followed by 30 minutes of computerized cognitive training. The difficult level of this training program will be adjusted automatically and continuously based on each participant's level of performance.
Procedure: aerobic exercise training
The aerobic exercise will first perform 3 minutes of warm-up followed by 25 minutes of resistive aerobic exercise and then 2 minutes cool-down. During the aerobic exercise the target heart rate will be 40 to 70% of maximal heart rate calculated as (208 - 0.7 age). The exercise intensity will be progressed as the participants improve their performance throughout practice. Vital signs and the Borg Perceived Exertion Scale will be monitored and recorded during exercise for each session.

Procedure: computerized cognitive training
The core function of cognitive training will be including attention, recognition, color and shape identification, calculation, visual perception, visuospatial processing and executive function. Participants will perform tasks designed to enhance abovementioned types of cognitive functions. The difficult level of this training program will be adjusted automatically and continuously based on each participant's level of performance. Cognitive training group will use commercialized cognitive based training programs to facilitate several cognitive functions. The core function will be including attention, recognition, color and shape identification, calculation, visual perception, visuospatial processing and executive function. Participants will perform tasks designed to enhance abovementioned types of cognitive functions. The difficult level of this training program will be adjusted automatically and continuously based on each participant's level of performance.




Primary Outcome Measures :
  1. Change scores of Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) ]
    The Montreal Cognitive Assessment (MoCA) will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30 and higher values indicate better cognitive functions. The MoCA has been shown to be a valid and promising tool to evaluate the global cognitive function in patients with stroke. The psychometric properties of MoCA are good to excellent for patients with cerebrovascular diseases.

  2. Change scores of Wechsler Memory Scale - Third Edition (WMS-III) [ Time Frame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) ]
    Several subtests of Wechsler Memory Scale - Third Edition (WMS-III) including Faces Recognition (total scale=48), Verbal Paired Associates (total scale = 32), Word Lists (total scale = 48), and Spatial Span (total scale=32) will be used to assess the immediate, delayed, and working memory tests. For each subtest, a higher number indicates better performance in memory function. The raw score of subtests will also be transferred to standardized Z scores and summed to represent an index of general memory function.

  3. Change scores of Stroop Color-Word test [ Time Frame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) ]
    The Stroop Color-Word test assesses the abilities of selective attention, inhibition and executive function. The participants will be tested under congruent and incongruent conditions. In the congruent condition, the participant will name the color ink of a word which is consistent with the written color name; whereas in the incongruent condition the participant will name the color ink differs from the written color name. In both conditions, the number of colors correctly named within 45 seconds will be measured and the performance in the congruent condition will be compared with the incongruent condition (Quaney et al., 2009).

  4. Change scores of Trail Making Test (TMT) [ Time Frame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) ]
    The TMT is a neuropsychological test of visual attention and task switching. It consists of two parts (TMT-A and TMT- B) in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The Chinese version of the TMT has been suggested to be a reliable instrument for measuring executive function among older adults. The scores for both TMT A and B are reported as the number of seconds required to complete the task. According to the TMT directions for administration, an average score for the TMT Part A is 29 seconds and a deficient score is greater than 78 seconds. For the TMT Part B, an average score is 75 seconds and a deficient score is greater than 273 seconds. Therefore, higher scores reveal greater impairment.

  5. Change scores of Six-minutes Walking Test (6MWT) [ Time Frame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) ]
    The 6MWT measures the maximum distance walked over 6 minutes, which assess the endurance and mobility level of the participants. The participants could rest as needed during the course of the test. The test-retest reliability and responsiveness has been established to be high for patients with chronic stroke (Fulk, Echternach, Nof, & O'Sullivan, 2008).

  6. Change scores of 30-second Chair-Stand Test (30CST) [ Time Frame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) ]
    The 30 second chair stand test (CST) will be assessed to indicate the strength and endurance level of the lower extremities. The participants will be asked to stand up from a standardized chair and then sit down as many times as possible within 30 seconds. The feasibility and reliability of using CST in people with cognitive impairment have been established to be good (Blankevoort et al., 2013).

  7. Change scores of Berg Balance Scale (BBS) [ Time Frame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) ]
    The Berg balance scale is a test of a person's static and dynamic balance abilities. This scale comprises a set of 14 simple balance related tasks, ranging from standing up from a sitting position, to standing on one foot. The degree of success in completing each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all scores. The range of score is 0-56 and a below average score indicates a high risk for falls. Excellent test-retest reliability has been reported in acquired brain injury.

  8. Change scores of Lower extremity muscle strength. [ Time Frame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) ]
    We will evaluate isometric knee flexors and extensors muscle strength using handheld dynamometer. The participant will be seated upright in a chair with back support, the knee will be placed in 90-degree flexion and the evaluator will stabilize the thing to eliminate synergistic movements. Participants will be asked to perform a maximal isometric contraction of knee flexion and extension with affected and less affected side. We will record the mean value of 3 attempts.

  9. Change scores of Mobility Level [ Time Frame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) ]
    An objective measure of the amount of arm movements in real-life situations will be provided by the accelerometers. Actigraphy activity monitors (ActiGraph, Shalimar, FL, USA) will be worn on participants' wrists for 3 consecutive days before and after training to measure the number of moves each minute, and the average counts of move per minute. The participants will be asked to wear the device during the day and data recorded by the actigraphy will be analyzed with the MAHUFFE software (http://www.mrc-epid.cam.ac.uk/). The use of actigraphy has been validated for patients with TBI.

  10. Change scores of Timed Up and Go test (TUG) [ Time Frame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) ]
    The TUG assesses the dynamic balance ability and mobility. The participants will be required to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The test-retest reliability of TUG on individuals with stroke was excellent (Ng & Hui-Chan, 2005).

  11. Change scores of Functional Independence Measure (FIM) [ Time Frame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) ]
    The FIM assesses the dependence level of individuals with stroke to perform 18 activities (13 motor and five cognitive tasks) in daily living. The score ranges from 18 to 126 and higher scores demonstrate greater independent participation in daily activities (Ottenbacher, Hsu, Granger, & Fiedler, 1996). The FIM has good interrater reliability and validity (Hsueh, Lin, Jeng, & Hsieh, 2002).

  12. Change scores of Activity Outcome Measurement for Post-Acute Care (AM-PAC) [ Time Frame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) ]
    The AM-PAC assess difficulties in daily participation with 58 items containing the following aspects: physical functioning, self-care, daily routine, communication, and interpersonal interaction. The items and scoring system are adopted from the ICF framework. The AM-PAC has adequate reliability and validity. There are three specific functional domains: basic mobility(score range=18-72), daily activity(score range=15-60) and applied cognitive(score range=19-76). For each subtest, a higher score indicates better performance.

  13. Change scores of Participation Measure-3 Domains, 4 Dimensions (PM-3D4D) [ Time Frame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) ]
    The PM-3D4D includes 24 items measuring participation in productivity(6 items), social(12 items), and community(6 items) domains across 4 dimensions: diversity of participation(Y/N), frequency of participation(0-6), desire for change(Y/N), and difficulty in participation(1-4). The score of diversity of participation is percent of the number of items in which a person answered yes divided by the total number of items within each domain. The score of frequency of participation is sum of the ratings divided by the total number of items within each domain. The score of desire for change is percent of the number of items in which a person answered yes divided by the total number of items within each domain. The score of difficulty in participation is total score within each domain. The PM-3D4D has been shown adequate reliability and validity in rehabilitation patients.

  14. Change scores of Goal Attainment Scaling (GAS) [ Time Frame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) ]
    The GAS assesses the extent to which patient's individual goals are achieved in the course of intervention. The GAS has been shown responsive to the change in cognitive rehabilitation. It used to quantify the extent to which treatment goals were achieved. Individual goals were evaluated in a standardized way, using predefined levels of achievement based on current and expected performance. A 5-point Goal Attainment Scale was used: the baseline level (-2), partial achievement (-1), the expected level of achievement (0), small better than expected levels (1), remarkably better than expected levels(2).

  15. Change scores of Beck depression inventory-version II (BDI-II) [ Time Frame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions) ]
    The Beck depression inventory is a self-report measure of depression severity. Excellent reliability and validity have been established in patients with TBI. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. The range of score is 0-63 and higher total scores indicate more severe depression.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) first episode non-progressive traumatic brain injury at least six months;
  • (2) Age range from 18 to 65 years;
  • (3) Rancho Los Amigo Level of Cognitive Functioning Scale (LOCF) = 7;
  • (4) Montreal cognitive assessment (MOCA) < 26;
  • (5) Self- or informant-reported memory or cognitive complaints;
  • (6) Able to follow the study instruction;
  • (7) Adequate cardiopulmonary function to perform aerobic exercise;
  • (8) Able to walk with or without assistive devices.

Exclusion Criteria:

  • (1) Unstable medical history (e.g., recent myocardial infarction) that might limit involving the training process;
  • (2) Concomitant with other neurological disorders (e.g., Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis);
  • (3) Current participation in another interventional trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051528


Contacts
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Contact: Ching-yi Wu, ScD #886-3-2118800 ext 5761 cywu@mail.cgu.edu.tw

Locations
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Taiwan
Chang Gung Memorial Hospital Enrolling by invitation
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Ching-yi Wu, ScD Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04051528     History of Changes
Other Study ID Numbers: 201802226B0A3
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
combinatorial training
Additional relevant MeSH terms:
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Brain Injuries, Traumatic
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries