SarcopeniaNCT04770558
Effectiveness of Interactive Exergame in Older Adults With Sarcopenia
A study testing Interactive Exergame in people with Sarcopenia, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Interactive Exergame
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Mar 2021to 11 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65-99 years old
- able to walk 6 meters without assistance devices
- older adults with possible sarcopenia, sarcopenia or severe sarcopenia
Who cannot join
- people with hemodialysis
- people with built-in electronic medical equipment
- people with central nervous system disease such as stroke or Parkinson's disease
- score in ascertain dementia 8 more than 2
- people with mental illness
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Community daycare center
Taipei
Shu-Chun Lee, PhD
About this study
Official title: Effectiveness of Interactive Exergame to Improve Physical and Cognitive Functions in Older Adults With Sarcopenia
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.
- Conditions
- Sarcopenia
- Being tested
- Interactive Exergame
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive ExergameOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exergame group | Experimental | The exergame group will receive exergame training for 12 weeks, 2 times a week and 60 min per session. Receives: Other: Interactive Exergame |
| Control group | No intervention | The control group will not receive any intervention and maintain their lifestyle for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline hand grip at Week 12
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.
Measured: Change from Baseline lower limbs strength at Week 12
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.
Measured: Change from Baseline appendicular muscle mass at Week 12
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.
Measured: Change from Baseline function ability at Week 12
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
Measured: Change from Baseline static balance at Week 12
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.
Measured: Change from Baseline walking ability at Week 12
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.
Measured: Change from Baseline fear of falling at Week 12
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.
Measured: Change from Baseline cognitive function at Week 12
Secondary outcomes (4)
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.
Measured: Change from Baseline physical activity at Week 12
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.
Measured: Change from Baseline diet record at Week 12
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.
Measured: Change from Baseline depression at Week 12
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.
Measured: Change from Baseline health-related quality of life at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start9 Mar 2021
- Primary completion11 Jan 2022 (estimated)
- Study completion11 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Chun Lee, Taipei Medical University
- Investigators
- Shu-Chun Lee, PhD, Principal investigator, School of Gerontology Health Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770558
- Sponsor's protocol ID
- N202012029
- Status last verified
- Mar 2021
- First submitted
- 21 Feb 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Interactive Exergame to Improve Physical and Cognitive Functions in Older Adults With Sarcopenia
- ClinicalTrials.gov ID
- NCT04770558
- Acronym / sponsor ID
- N202012029
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 11 Jan 2022 (estimated)
- Study completion
- 11 Jan 2022 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergame group | Experimental | Other: Interactive ExergameThe exergame group will receive exergame training for 12 weeks, 2 times a week and 60 min per session. |
| Control group | No intervention | –The control group will not receive any intervention and maintain their lifestyle for 12 weeks. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65-99 years old
- able to walk 6 meters without assistance devices
- older adults with possible sarcopenia, sarcopenia or severe sarcopenia
Key exclusion criteria (5 listed)
- people with hemodialysis
- people with built-in electronic medical equipment
- people with central nervous system disease such as stroke or Parkinson's disease
- score in ascertain dementia 8 more than 2
- people with mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive ExergameThe 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. | Other | Exergame group |
Primary outcome
Hand grip
Time frame: Change from Baseline hand grip at Week 12
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.
Lower limbs strength
Time frame: Change from Baseline lower limbs strength at Week 12
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.
Appendicular muscle mass
Time frame: Change from Baseline appendicular muscle mass at Week 12
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.
Function ability
Time frame: Change from Baseline function ability at Week 12
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.
Static balance
Time frame: Change from Baseline static balance at Week 12
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
Walking ability
Time frame: Change from Baseline walking ability at Week 12
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.
Fear of falling
Time frame: Change from Baseline fear of falling at Week 12
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.
Cognitive function
Time frame: Change from Baseline cognitive function at Week 12
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.
4 secondary outcomes
Physical Activity
Time frame: Change from Baseline physical activity at Week 12
Diet record
Time frame: Change from Baseline diet record at Week 12
Depression
Time frame: Change from Baseline depression at Week 12
Health-related quality of life
Time frame: Change from Baseline health-related quality of life at Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Chun Lee, PhD principal investigator
School of Gerontology Health Management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Exergame in people with Sarcopenia, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Chun Lee, PhD (0963210548, sclee@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand grip (time frame: Change from Baseline hand grip at Week 12). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.