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

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Unknown

Conditions

Cognitive Deficit
Trauma, Brain

Treatments

Procedure: computerized cognitive training
Procedure: aerobic exercise training
Procedure: guiding training

Study type

Interventional

Funder types

Other

Identifiers

NCT04051528
201802226B0A3

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

combinatorial training group
Experimental group
Description:
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.
Treatment:
Procedure: aerobic exercise training
Procedure: guiding training
Procedure: computerized cognitive training
sequential training group.
Experimental group
Description:
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.
Treatment:
Procedure: aerobic exercise training
Procedure: computerized cognitive training

Trial contacts and locations

1

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Central trial contact

Ching-yi Wu, ScD

Data sourced from clinicaltrials.gov

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