Benefits of Digital Dance Game by Older Adults

Aged Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05411042
• Other study ID #: YM108123F_D
• Status: Completed
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: March 20, 2022

Study information

• Verified date: June 2020
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 20, 2022
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 76 Years

Eligibility

Inclusion Criteria:

1. Age = 55 years old.

2. More than 6 years of formal education.

3. Can communicate in Mandarin and Taiwanese.

4. Can accept MRI examination without claustrophobia.

5. Can understand the research process, meet the requirements of the research, and can sign the consent form and participate in the subject.

Exclusion Criteria:

1. Have engaged in any video dancing games in the past three months.

2. Engaged in video dancing games more than three times per year in the past three years.

Related Conditions & MeSH terms

• Aged

Intervention

Device:
• Dance somatosensory game
dance somatosensory game (DSG), DANZ BASE developed by International Games System Company

Locations

Country	Name	City	State
Taiwan	Center for Geriatrics and Gerontology, Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in MRI study	Change in MRI study from baseline to 6 months in the intervention group.	from baseline to 6 months
Secondary	Montreal Cognitive Assessment (MoCA)	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.	from baseline to 6 months
Secondary	EuroQol instrument (EQ-5D)	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.	from baseline to 6 months
Secondary	International Physical Activity Questionnaire (IPAQ)	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.	from baseline to 6 months
Secondary	Brief Resilience Scale (BRS)	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.	from baseline to 6 months
Secondary	Demoralization Scale-Mandarin Version (DS-MV)	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.	from baseline to 6 months