Clinical trial NCT05411042: Benefits of Digital Dance Game by Older Adults
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aged
Keywords: Digital dance game
older adults
Brain gray matter volume
cognitive performance
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in MRI study
timeFrame: from baseline to 6 months
Secondary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: from baseline to 6 months
measure: EuroQol instrument (EQ-5D)
timeFrame: from baseline to 6 months
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: from baseline to 6 months
measure: Brief Resilience Scale (BRS)
timeFrame: from baseline to 6 months
measure: Demoralization Scale-Mandarin Version (DS-MV)
timeFrame: from baseline to 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Center for Geriatrics and Gerontology, Taipei Veterans General Hospital
Study officials:
affiliation: Aging and Health Research Center, National Yang-Ming University
name: Liang-Kung Chen, M.D., PhD
role: STUDY_DIRECTOR
References: