NCT05802537

Brief Summary

The purpose of this study was to investigate the effect of a home-based exergame program on physical function, fall efficacy, depression, and quality of life in older adults. For the purpose of the study, the investigators established the following hypotheses. Older adults who participate in a home-based exergame program will experience significant improvements in physical function, fall efficacy, depression, and quality of life compared to those who do not participate in the program.

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 Nov 2022

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 1, 2022

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

6 days

First QC Date

March 18, 2023

Last Update Submit

November 1, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • One-leg standing test

    The one-leg standing test was used to evaluate static postural balance. The one-leg standing test is a simple, reliable, and valid test for assessing balance and fall risk in older adults.

    Change from baseline after intervention at 8 weeks

  • Berg balance scale

    To evaluate dynamic postural balance, the Berg balance scale was used. It has a perfect score of 56 and consists of 14 items, with a perfect score of 4 for each item.

    Change from baseline after intervention at 8 weeks

  • Functional reaching test

    Functional reaching test was used to evaluate movement limits.

    Change from baseline after intervention at 8 weeks

  • Timed up-and-go test

    Timed up-and-go test was used to assess functional movement and mobility.

    Change from baseline after intervention at 8 weeks

  • Five-times sit-to-stand test

    Five-times sit-to-stand test was used to evaluate lower-extremity muscle strength.

    Change from baseline after intervention at 8 weeks

Secondary Outcomes (3)

  • Falls Efficacy

    Change from baseline after intervention at 8 weeks

  • Depression

    Change from baseline after intervention at 8 weeks

  • Health-Related Quality of Life

    Change from baseline after intervention at 8 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants in the experimental group engaged in a home-based exergame program for 50 minutes per session, three times per week, for eight weeks. The program focused on enhancing lower extremity strength and balance.

Behavioral: Home-based exergame program

Control group

ACTIVE COMPARATOR

The control group participated in weekly online education sessions for 50 minutes over an eight-week period. The topics covered included fall prevention, musculoskeletal health, aging, and fracture risks. No physical exercise intervention was given.

Behavioral: Online education on fall prevention and musculoskeletal health management

Interventions

The home-based exergame program was conducted using the Nintendo Switch and Ring Fit Adventure program at participants' homes. The program included a 10-minute warm-up, 30 minutes of main exercise, and a 10-minute cool-down, lasting a total of 50 minutes per session. Sessions were held three times per week for eight weeks. The exercises targeted lower extremity strength, balance, and flexibility and included yoga, leg exercises (e.g., squats, knee lifts), and other activities performed in a gamified virtual environment. Participants received guidance on using the console, and family members were involved to support proper execution of the exercises.

Experimental group

The online education intervention consisted of weekly sessions conducted for 50 minutes over an eight-week period, focusing on fall prevention and musculoskeletal health management. Participants joined the sessions via a video-conference platform. The content covered education on aging, musculoskeletal disorders, fall prevention strategies, and understanding falls and fractures. These sessions aimed to enhance participants' awareness and knowledge, thereby helping them adopt preventive behaviors.

Control group

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years or older
  • the ability to walk independently with or without a walking aid
  • a mini-mental state examination score ≥ 24.

You may not qualify if:

  • musculoskeletal disorders such as fractures or dislocations
  • neurological impairment
  • mental disorders
  • uncontrolled endocrine, cardiovascular, or urinary system diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungdong University

Wŏnju, Gangwon-do, 26495, South Korea

Location

Related Publications (1)

  • Lee K. Home-Based Exergame Program to Improve Physical Function, Fall Efficacy, Depression and Quality of Life in Community-Dwelling Older Adults: A Randomized Controlled Trial. Healthcare (Basel). 2023 Apr 12;11(8):1109. doi: 10.3390/healthcare11081109.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 18, 2023

First Posted

April 6, 2023

Study Start

November 1, 2022

Primary Completion

November 7, 2022

Study Completion

January 13, 2023

Last Updated

November 5, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations