NCT03940079

Brief Summary

The declination on cognitive and motor functions in older adults increases the difficulty to achieve successful aging. Previous studies had reported that contrast to the traditional cognitive training methods, computer cognitive training (CCT) is comparable or has better effect on the cognitive function improvement with elders.On the other hand, some researchers claimed motor-cognitive dual-task training may possess greater effects than single cognitive training on cognitive functions. However, it is still on debate. Therefore, the research aims to investigate cognitive and motor benefits to healthy older adults over 65s trained by our computer-based cognitive game with high and low level of motor engagements.The research questions include: (1) Is CCT beneficial of cognitive functions? (2) Does CCT with high level of motor engagements (i.e. motor-cognitive dual-task training) have greater effects than single cognitive training on cognitive functions? (3) Can the training effect remain?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

May 5, 2019

Last Update Submit

August 9, 2020

Conditions

Outcome Measures

Primary Outcomes (7)

  • Change from Baseline Montreal Cognitive Assessment (MoCA) Taiwan Version at the 4th, 8th and 16th weeks

    overall cognitive function

    baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up

  • Change from Baseline Digit Span Task-forward (DS-forward) at the 4th, 8th and 16th weeks

    short-term memory

    baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up

  • Change from Baseline Color Trails Test-2 (CTT-2) at the 4th, 8th and 16th weeks

    divided attention

    baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up

  • Change from Baseline Stroop Color Word Test (SCWT) at the 4th, 8th and 16th weeks

    inhibitory function

    baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up

  • Change from Baseline Nine Hole Peg Test (NHPT) at the 4th, 8th and 16th weeks

    motor function of upper limbs

    baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up

  • Change from Baseline Get-Up and Go Test (GUG) at the 4th, 8th and 16th weeks

    motor function of lower limbs and balance

    baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up

  • Change from Baseline Five-Times-Sit-to-Stand Test (FTSST) at the 4th, 8th and 16th weeks

    motor function of lower limbs and balance

    baseline, 4th weeks pretest, 8th weeks posttest, 16th weeks follow-up

Secondary Outcomes (3)

  • Change from 4th weeks Game1 (first scenario) evaluated the performance of short-term memory at 8th weeks

    4th weeks pretest, 8th weeks posttest

  • Change from 4th weeks Game2 (second scenario) evaluated divided attention at 8th weeks

    4th weeks pretest, 8th weeks posttest

  • Change from 4th weeks Game3 (third scenario) evaluated inhibitory function at 8th weeks

    4th weeks pretest, 8th weeks posttest

Study Arms (2)

gross-motor group (GMG)

EXPERIMENTAL

The participants of GMG received motor-cognitive dual-task training. The sensors used by the participants were four different colored buttons. The participants wear a suit with two buttons on the shoulders and the other two fasten on the knees by velcros. To accomplish the tasks, the participants had to slap the correct colored buttons. The stretching of upper or lower limbs was demanding while slapping, so the participants of GMG received a training which required cognitive and motor functions at the same time. The participants attended 2 sessions per week and lasted for 4 weeks. Each session lasted 75 minutes, mainly including 30 minutes for game introduction and warm-up, 30 minutes for game training, and 15 minutes for rest during the training. Each task lasted 10 minutes, and each session contained 3 tasks. The game difficulty could be adjusted automatically according to the performance of participants.

Device: computer-based cognitive game (including 3 training tasks)

fine-motor group (FMG)

ACTIVE COMPARATOR

The participants of FMG received cognitive training only. Four colored sensors used by the participants were the keys on the keyboard of the laptop. The participants simply pressed correct colored keys by fingers to complete the tasks. The participants attended 2 sessions per week and lasted for 4 weeks. Each session lasted 75 minutes, mainly including 30 minutes for game introduction and warm-up, 30 minutes for game training, and 15 minutes for rest during the training. Each task lasted 10 minutes, and each session contained 3 tasks. The game difficulty could be adjusted automatically according to the performance of participants.

Device: computer-based cognitive game (including 3 training tasks)

Interventions

First task was short-term memory training. Participants were instructed to memorize different colored circles with ordinal numbers which would disappear later. They triggered correct colored sensor in sequence according to their memory. Second task was divided attention training. Different colored circles with ordinal numbers would not disappear this time.The participants should trigger correct colored sensor according to their sequence. Third task was inhibitory function training. There were red and green lights, just like the traffic light, hung up at the upper left of the scene. Red light represented prohibition of triggering the colored sensor, while green light urged to trigger it. Yellow, red, blue and green circles showed up randomly and moved toward the beige region. When the circle came extremely closer to the beige region, the traffic light was randomized to lighten up red or green.The participants should judge and trigger the correct colored sensor.

fine-motor group (FMG)gross-motor group (GMG)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • ≥ 65 years old
  • Montreal Cognitive Assessment (MoCA) score ≥ 18
  • clear eyesight and hearing
  • both upper and lower limbs are functional
  • normal communication

You may not qualify if:

  • injury, fracture, and breathing problem
  • surgery during the research
  • severe disease affecting cognitive functions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Study Officials

  • Central Contact Backup Mao

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2019

First Posted

May 7, 2019

Study Start

May 1, 2018

Primary Completion

June 27, 2018

Study Completion

June 27, 2018

Last Updated

August 11, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations