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OpenTrials
Completed

NCT Number: NCT05411042

Benefits of Digital Dance Game by Older Adults

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.

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Key information

Conditions

Aged

Age range

55 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Geriatrics and Gerontology, Taipei Veterans General Hospital

Taipei, 112, Taiwan

About this study

This randomized controlled trial followed the CONSORT guidelines to compare the clinical efficacy of the intervention group with the control group. 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.

The primary outcome of the trial was changes of gray matter volume of the brain done by 3T brain magnetic resonance imaging during the study period. The secondary outcomes included cognitive performance, quality of life, physical activities, resilience, and demoralization. For all outcome variables, the measurements at the baseline and 6-month follow-up were examined by a random intercept and a fixed slope, and the effect of the intervention was estimated by using the Generalized Estimating Equation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Dance somatosensory game

Device

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

Primary outcomes

  1. Change in MRI study

    Time frame: from baseline to 6 months

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

Secondary outcomes

  1. Montreal Cognitive Assessment (MoCA)

    Time frame: from baseline to 6 months

    Cognitive function measure by MoCA , which comprise a 30-question test.Score range: 0-30, and a score of 26 and higher is considered normal.

  2. EuroQol instrument (EQ-5D)

    Time frame: from baseline to 6 months

    Quality of life measure by EQ-5D, which include five questions on mobility, self care, pain, usual activities, and psychological status.There are three level of the answers for each question, the maximum score of 1 refers to the best condition without problem, and higher scores refers more severe of the issue. Moreover, the visual analogue scale (VAS) which from 0-100, higher score indicating better health status.

  3. International Physical Activity Questionnaire (IPAQ)

    Time frame: from baseline to 6 months

    Physical activity measured by IPAQ, indicates that spent being physically active within the prior 7 days.There are no established thresholds for presenting MET-minutes, the IPAQ Research Committee proposes that reported as comparisons of median values and interquartile ranges for different populations.

  4. Brief Resilience Scale (BRS)

    Time frame: from baseline to 6 months

    Resilience measured by BRS to assess ability to bounce back or recover from stress and adversity. Score range: 6-30, and higher scores refers to higher level of resilience.

  5. Demoralization Scale-Mandarin Version (DS-MV)

    Time frame: from baseline to 6 months

    Demoralization measure by DS-MV, comprised 24 items and each rated on a five-point Likert scale.Score range: 0-96, and cut-off point score ≥30 was considered to identified demoralization.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

Benefits of Digital Dance Game Participation by Older Adults on Brain Gray Matter Volume, Physical Function, Cognitive Performance, and Quality of Life: a Randomized Controlled Trial.

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 8, 2022
Registry last updated
Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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