Clinical trial NCT04051528: Do Combinatorial Training Lead to Better Cognition and Daily Participation in TBI Persons With Cognitive Impairments
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trauma, Brain
Cognitive Deficit
Keywords: combinatorial training
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change scores of Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Wechsler Memory Scale - Third Edition (WMS-III)
timeFrame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Stroop Color-Word test
timeFrame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Trail Making Test (TMT)
timeFrame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Six-minutes Walking Test (6MWT)
timeFrame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of 30-second Chair-Stand Test (30CST)
timeFrame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Berg Balance Scale (BBS)
timeFrame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Lower extremity muscle strength.
timeFrame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Mobility Level
timeFrame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Timed Up and Go test (TUG)
timeFrame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Functional Independence Measure (FIM)
timeFrame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Activity Outcome Measurement for Post-Acute Care (AM-PAC)
timeFrame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Participation Measure-3 Domains, 4 Dimensions (PM-3D4D)
timeFrame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Goal Attainment Scaling (GAS)
timeFrame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Beck depression inventory-version II (BDI-II)
timeFrame: Baseline, post test immediately after completing 16 intervention sessions (around 8 weeks after baseline), follow up test (6 months after completing intervention sessions)
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ching-yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References: