NCT05411042

Brief Summary

This study aims to examine the clinical efficacy of dancing somatosensory videogames in improving physical health, cognitive performance, happiness, laboratory biomarkers, and structural brain imaging (magnetic resonance imaging, MRI) by a randomized controlled trial design, and hopefully to expand the scope of healthy aging intervention activities with strong scientific evidence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

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

August 31, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2020

Enrollment Period

1.2 years

First QC Date

June 6, 2022

Last Update Submit

June 8, 2022

Conditions

Keywords

Digital dance gameolder adultsBrain gray matter volumecognitive performance

Outcome Measures

Primary Outcomes (1)

  • Change in MRI study

    Change in MRI study from baseline to 6 months in the intervention group.

    from baseline to 6 months

Secondary Outcomes (5)

  • Montreal Cognitive Assessment (MoCA)

    from baseline to 6 months

  • EuroQol instrument (EQ-5D)

    from baseline to 6 months

  • International Physical Activity Questionnaire (IPAQ)

    from baseline to 6 months

  • Brief Resilience Scale (BRS)

    from baseline to 6 months

  • Demoralization Scale-Mandarin Version (DS-MV)

    from baseline to 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The experimental group intervened a dance somatosensory game (DSG), DANZ BASE developed by International Games System Company, at the Xinzhuang health center, which is a local bureau with outpatient clinic. The participants in experimental group played twice a week, each time requiring at least lasting 30 minutes, for half of a year.

Device: Dance somatosensory game

Control group

NO INTERVENTION

The control group only performed routine data collection; the research assistant asked the subjects about their usual activities by telephone every month to understand their physical activity in this half of the year.

Interventions

dance somatosensory game (DSG), DANZ BASE developed by International Games System Company

Intervention group

Eligibility Criteria

Age55 Years - 76 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 55 years old.
  • More than 6 years of formal education.
  • Can communicate in Mandarin and Taiwanese.
  • Can accept MRI examination without claustrophobia.
  • Can understand the research process, meet the requirements of the research, and can sign the consent form and participate in the subject.

You may not qualify if:

  • Have engaged in any video dancing games in the past three months.
  • Engaged in video dancing games more than three times per year in the past three years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Geriatrics and Gerontology, Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Related Publications (1)

  • Tung HH, Kuo CY, Lee PL, Chang CW, Chou KH, Lin CP, Chen LK. Efficacy of Digital Dance on Brain Imagery, Cognition, and Health: Randomized Controlled Trial. J Med Internet Res. 2024 Jul 30;26:e57694. doi: 10.2196/57694.

Study Officials

  • Liang-Kung Chen, M.D., PhD

    Aging and Health Research Center, National Yang-Ming University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The intervention group and control group were randomly allocated (1:1) with no stratification. The intervention group received the dance somatosensory videogame (DSG) training program at the community health center, which consisted of two 30-minute sessions per week for 6 months. The control group were provided with health education for healthy aging and were followed by telephone survey for their daily activities every month during the study period.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2022

First Posted

June 8, 2022

Study Start

August 31, 2020

Primary Completion

October 25, 2021

Study Completion

March 20, 2022

Last Updated

June 10, 2022

Record last verified: 2020-06

Locations