Home-Based Exergame Program for Community-Dwelling Older Adults

November 1, 2024 updated by: Kyeongjin Lee, Kyungdong University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangwon-do
      • Wonju, Gangwon-do, Korea, Republic of, 26495
        • Kyungdong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
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
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.
Active Comparator: Control group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
One-leg standing test
Time Frame: Change from baseline after intervention at 8 weeks
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
Time Frame: Change from baseline after intervention at 8 weeks
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
Time Frame: Change from baseline after intervention at 8 weeks
Functional reaching test was used to evaluate movement limits.
Change from baseline after intervention at 8 weeks
Timed up-and-go test
Time Frame: Change from baseline after intervention at 8 weeks
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
Time Frame: Change from baseline after intervention at 8 weeks
Five-times sit-to-stand test was used to evaluate lower-extremity muscle strength.
Change from baseline after intervention at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Falls Efficacy
Time Frame: Change from baseline after intervention at 8 weeks
Falls efficacy was evaluated using the Modified Falls Efficacy Scale (MFES), which was specifically developed for older adults. The MFES consists of 14 questions, each scored from 0 (not confident) to 10 (very confident). The total score ranges from 0 to 140, with higher scores indicating greater confidence in performing activities without falling, which is considered a better outcome.
Change from baseline after intervention at 8 weeks
Depression
Time Frame: Change from baseline after intervention at 8 weeks
Depression was measured using the Geriatric Depression Scale-15 (GDS-15), a validated screening tool for older adults. The GDS-15 consists of 15 yes/no questions, with scores ranging from 0 to 15. Higher scores represent more severe depressive symptoms, which is considered a worse outcome.
Change from baseline after intervention at 8 weeks
Health-Related Quality of Life
Time Frame: Change from baseline after intervention at 8 weeks
Health-related quality of life was measured using the 36-Item Short Form Health Survey (SF-36), which assesses multiple domains of health status, including physical functioning, pain, role limitations, emotional problems, mental health, social functioning, vitality, and general health. The SF-36 contains 36 items, each rated on a scale from 1 to 5, with the total score converted to a range from 0 to 100. Higher scores indicate better health outcomes, reflecting a better quality of life.
Change from baseline after intervention at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kyungdong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 7, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1041455-202302-HR-003-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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