CClinicalTrials.gg
Status unknownNCT04770558Updated Apr 1, 2021

Effectiveness of Interactive Exergame in Older Adults With Sarcopenia

An interventional study of Interactive Exergame in Sarcopenia, sponsored by Taipei Medical University. Status unknown at 1 site in Taiwan. Open to participants aged 65 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-01.

Sponsored by Taipei Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
65 Years to 99 Years
Sex
All
01

Study summary

Sarcopenia has been defined as an age related, involuntary loss of skeletal muscle mass and strength. The prevalence of sarcopenia is about 10% globally, and risk factors of sarcopenia includes age, lower physical activity, and malnutrition. Sarcopenia can lead to many adverse health outcomes, particularly in physical and cognitive functions. Most of previous studies have reported that interactive exergame can improve cognitive and physical functions in older population but none of studies use of interactive exergame on older adults with sarcopenia. Therefore, the aim of study will investigate the effects of interactive exergame on older adults with sarcopenia.

Read the detailed description

A total of 60 older participants will be randomly assigned to the experimental and control groups. Participants in the experimental group will receive 40 minutes per session, 2 times a week for 12 weeks interactive exergame while those in the control group will maintain their regular activity. All participants will be assessed their physical and cognitive function, sarcopenia index and other health related outcome measurements before and after intervention program.

02

Conditions studied

  • Sarcopenia

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03

In context

Sarcopenia

1,206 studies on the registry are indexed under Sarcopenia; 401 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 773 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Taipei Medical University is the lead sponsor of 245 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 65-99 years old
  2. able to walk 6 meters without assistance devices
  3. older adults with possible sarcopenia, sarcopenia or severe sarcopenia

Exclusion criteria

Exclusion Criteria:

  1. people with hemodialysis
  2. people with built-in electronic medical equipment
  3. people with central nervous system disease such as stroke or Parkinson's disease
  4. score in ascertain dementia 8 more than 2
  5. people with mental illness
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Exergame group

    The exergame group will receive exergame training for 12 weeks, 2 times a week and 60 min per session.

    Other: Interactive Exergame

  • No intervention
    Control group

    The control group will not receive any intervention and maintain their lifestyle for 12 weeks.

Interventions

  • OtherInteractive Exergame

    The one-to-one supervised training session consists of 10 min warm-up exercise, 40 min interactive exergame, and 10 min cool-down exercise. Both physical (muscle strength, coordination and balance in lower limbs) and cognitive functions (visuospatial, attention, short-term memory, calculation, reaction and executive function) will be trained through the interactive exergame.

06

What researchers measure

Primary outcomes

  1. Hand grip

    Dominant hand grip (kg) will measured by a dynamometer. Participants will stand with their arms down by their sides. They will squeeze the dynamometer with maximum isometric effort, which is maintained for 6 seconds. Female less than 18 kg and man less than 28 kg indicate weakness in grip strength.

    Time frame: Change from Baseline hand grip at Week 12

  2. Lower limbs strength

    Lower limbs strength will be assessed by the Five Times Sit to Stand. Participants will be asked to sit on the chair with arms folded across their chest, and stand up and sit down as quickly as possible for 5 times. The time (s) to complete the task will be recorded.The time more than 12 seconds indicates weakness in lower limbs strength.

    Time frame: Change from Baseline lower limbs strength at Week 12

  3. Appendicular muscle mass

    Appendicular muscle mass will be assessed by the Body Impedance Analysis (BIA).Participants will be asked to stand on the machine and hold the handle of the machine. Female less than 5.7kg/m2 and male less than 7 kg/m2 indicate lower muscle mass.

    Time frame: Change from Baseline appendicular muscle mass at Week 12

  4. Function ability

    Function ability test will be determined by the timed up and go test (TUG). Participants will be asked to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. The times(s) to complete the task will be recorded. Higher than 12s indicate weakness in function ability.

    Time frame: Change from Baseline function ability at Week 12

  5. Static balance

    Static balance test will be assessed by the modified Clinical Test for Sensory Interaction in Balance(mCTSIB), The mCTSIB was developed as a clinical version of the Sensory Organization Test and was developed to assesses sensory contributions to postural control. Participants will stand with their hands at their sides, feet together and perform the following 4 sensory conditions: (1) Stand on firm surface with eyes open (2) Stand on firm surface with eyes closed (3) Stand on foam surface with eyes open (4) Stand on foam surface with eyes closed. Each condition will be timed for maximum 30 seconds. The test is terminated when a participant's arms or feet moves. If participants are unable to maintain the position for 30 seconds, they are then provided with 2 additional attempts. The time (s) to complete each condition will be recorded.If they can't complete this test indicate weakness in static balance

    Time frame: Change from Baseline static balance at Week 12

  6. Walking ability

    Walking ability test will be measured by the 6 meter walk test. Participant will be asked to walk at their self-selected speed. The time for the middle 6 meters will be recorded and walking speed (m/s) will be calculated.

    Time frame: Change from Baseline walking ability at Week 12

  7. Fear of falling

    Fear of falling will be measured by the Falls Efficacy Scale- International (FES-I). The FES-I rates each daily task from "no confident at all" to "completely confident". The total score is between 16 and 64, and the score more than 28 indicates higher level of fear of falling.

    Time frame: Change from Baseline fear of falling at Week 12

  8. Cognitive function

    Cognitive function will be evaluated by the Montreal Cognitive Assessment (MoCA), which includes visuospatial abilities, short-term memory recall task, multiple aspects of executive functions, attention, concentration, and working memory. The total score is 30 and the score less than 26 indicates mild cognitive impairment.

    Time frame: Change from Baseline cognitive function at Week 12

Secondary outcomes

  1. Physical Activity

    Physical Activity will be examined by the International Physical Activity Questionnaire (IPAQ)-Short Form. Participants will be asked about their duration (in minutes) and frequency (days) when performing four specific types of activity: walking, moderate intensity, vigorous intensity and sitting. Female less than 270 kcal and male less than 383 kcal indicate low physical activity.

    Time frame: Change from Baseline physical activity at Week 12

  2. Diet record

    Diet record will be examined by the Three Day Diet Record. Participants will be asked to record their three random days' protein diet during a week, every week when they start the intervention, researchers will record their new data.

    Time frame: Change from Baseline diet record at Week 12

  3. Depression

    Depression will be evaluated by the Geriatric Depression Scale (GDS) consisting of 15 questions. Participants will be asked to recall their feelings about some things in the past week. The answer is "Yes" or "No". The score is calculated according to the nature of the question, and the total score is 15 points. The higher the score, the higher the degree of depression. When the score is greater than 5 points, it indicates the presence of depression.

    Time frame: Change from Baseline depression at Week 12

  4. Health-related quality of life

    Quality of life will be evaluated by the WHOQOL-BREF Taiwan version consisting of 28 questions, which is simplified from the WHOQOL long form. Two of these questions are self-evaluated quality of life and health status, other 26 questions fall into four categories (physiological, psychological, social, and environmental quality of life).The higher score and the better quality of life.

    Time frame: Change from Baseline health-related quality of life at Week 12

Other outcomes

  1. Sarcopenia screening

    Sarcopenia will be screened by the SARC-F questionnaire including strength, assistant in walking, rise from a chair, climb stair and fall. The answer is not difficult with 0 point, a little difficult with 1 point and very difficult with 2 points.The score is total score is between 0 and 10. The score more than 4 indicates high risk of sarcopenia.

    Time frame: Baseline

  2. Dementia screening

    Dementia will be screened by Ascertain dementia 8(AD-8) including 1.problems with judgment 2.decreased interest 3.repeats 4.learning 5.forgets month or year 6.handling financial 7.trouble remembering appointments 8.problems with memory.They consider the changes in the past and the present, instead of responding to their current performance.The score more than 2 indicates high risk of dementia.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Community daycare center
    Taipei, Taiwan
    • Shu-Chun Lee, PhD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04770558
Lead sponsor
Taipei Medical University
Responsible party
Shu-Chun Lee (Assistant Professor, Taipei Medical University) — Principal investigator
First posted
Feb 25, 2021
Start date
Mar 9, 2021
Primary completion
Jan 11, 2022 (estimated)
Completion
Jan 11, 2022 (estimated)
Last update
Apr 1, 2021

Study contacts

Shu-Chun Lee, PhD
Contact
sclee@tmu.edu.tw
0963210548
Shu-Chun Lee, PhD
principal investigator · School of Gerontology Health Management

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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