NCT04051528

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trauma, Brain
• Cognitive Deficit

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-03
• Primary completion: 2021-07-01
• Completion: 2022-01-01
• First posted: 2019-08-09
• Last updated: 2021-06-21

Locations

1 site across 1 country: Taiwan