NCT04284709

Brief Summary

This study aimed to utilize an interactive exergame mat system to develop a novel cognitive-physical training program and explore the training effects on physical performance, cognitive function, dual-task walking (DTW), and fall risk compared to the control condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

6 months

First QC Date

February 20, 2020

Last Update Submit

February 23, 2020

Conditions

Outcome Measures

Primary Outcomes (13)

  • change in lower-limb muscle strength

    30-second chair stand test

    before and after 3-month exercise training interventions

  • change in upper-limb muscle strength

    30-second arm curl test

    before and after 3-month exercise training interventions

  • change in aerobic endurance

    2-minute step test

    before and after 3-month exercise training interventions

  • change in lower-body flexibility

    chair sit and reach test

    before and after 3-month exercise training interventions

  • change in upper-body flexibility

    back scratch test

    before and after 3-month exercise training interventions

  • change in dynamic balance

    8-foot up and go test

    before and after 3-month exercise training interventions

  • change in static balance

    single-leg stand test

    before and after 3-month exercise training interventions

  • change in grasp strength

    hand grip strength

    before and after 3-month exercise training interventions

  • change in lower limb motor function

    foot tapping test

    before and after 3-month exercise training interventions

  • change in cognitive function

    Montreal Cognitive Assessment

    before and after 3-month exercise training interventions

  • change in cognitive dual-task walking

    8-foot up and go walking while counting

    before and after 3-month exercise training interventions

  • change in motor dual-task walking

    8-foot up and go walking while carrying a tray

    before and after 3-month exercise training interventions

  • change in fall risk

    fall risk questionnaire

    before and after 3-month exercise training interventions

Study Arms (2)

exercise group

EXPERIMENTAL

exergames with simultaneous cognitive-physical training

Other: cognitive-physical training

control group

ACTIVE COMPARATOR

multicomponent exercise intervention focused on physical and cognitive training

Other: cognitive-physical training

Interventions

combined physical and cognitive training

control groupexercise group

Eligibility Criteria

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

You may qualify if:

  • aged 65 years or older, and being able to walk independently without any assistive devices

You may not qualify if:

  • had severe lower-extremity joint pain, cognitive impairment, or visual problems that impeded their participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, 11219, Taiwan

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Chen-Yi Song

    National Taipei University of Nursing and Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 26, 2020

Study Start

November 14, 2018

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

February 26, 2020

Record last verified: 2020-02

Locations