- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05802537
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
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
60
Phase
- 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
-
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Gangwon-do
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Wonju, Gangwon-do, Korea, Republic of, 26495
- Kyungdong University
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
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.
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Change from baseline after intervention at 8 weeks
|
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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
|
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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.
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Change from baseline after intervention at 8 weeks
|
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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
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.
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Change from baseline after intervention at 8 weeks
|
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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.
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Change from baseline after intervention at 8 weeks
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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.
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Change from baseline after intervention at 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
November 1, 2022
Primary Completion (Actual)
November 7, 2022
Study Completion (Actual)
January 13, 2023
Study Registration Dates
First Submitted
March 18, 2023
First Submitted That Met QC Criteria
March 25, 2023
First Posted (Actual)
April 6, 2023
Study Record Updates
Last Update Posted (Estimated)
November 5, 2024
Last Update Submitted That Met QC Criteria
November 1, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Other Study ID 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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