Do Combinatorial Training Lead to Better Cognition & Daily Participation

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04051528
Study type	Interventional
Source	Chang Gung Memorial Hospital
Contact	Ching-yi Wu, ScD
Phone	#886-3-2118800
Email	cywu@mail.cgu.edu.tw
Status	Recruiting
Phase	N/A
Start date	June 3, 2020
Completion date	January 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms