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

NCT04051528 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-06-21

No results posted yet for this study

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.

Conditions

  • Trauma, Brain
  • Cognitive Deficit

Interventions

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.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Ching-yi Wu, ScD · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-03
Primary Completion
2021-07-31
Completion
2022-01-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04051528 on ClinicalTrials.gov