Effectiveness of Interactive Exergame in Older Adults With Sarcopenia
Primary Purpose
Sarcopenia
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Interactive Exergame
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia
Eligibility Criteria
Inclusion Criteria:
- 65-99 years old
- able to walk 6 meters without assistance devices
- older adults with possible sarcopenia, sarcopenia or severe sarcopenia
Exclusion Criteria:
- 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
Sites / Locations
- Community daycare centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exergame group
Control group
Arm Description
The exergame group will receive exergame training for 12 weeks, 2 times a week and 60 min per session.
The control group will not receive any intervention and maintain their lifestyle for 12 weeks.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT04770558
First Posted
February 21, 2021
Last Updated
March 30, 2021
Sponsor
Taipei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04770558
Brief Title
Effectiveness of Interactive Exergame in Older Adults With Sarcopenia
Official Title
Effectiveness of Interactive Exergame to Improve Physical and Cognitive Functions in Older Adults With Sarcopenia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 9, 2021 (Actual)
Primary Completion Date
January 11, 2022 (Anticipated)
Study Completion Date
January 11, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exergame group
Arm Type
Experimental
Arm Description
The exergame group will receive exergame training for 12 weeks, 2 times a week and 60 min per session.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will not receive any intervention and maintain their lifestyle for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Interactive Exergame
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hand grip
Description
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
Title
Lower limbs strength
Description
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
Title
Appendicular muscle mass
Description
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
Title
Function ability
Description
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
Title
Static balance
Description
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
Title
Walking ability
Description
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
Title
Fear of falling
Description
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
Title
Cognitive function
Description
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 Outcome Measure Information:
Title
Physical Activity
Description
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
Title
Diet record
Description
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
Title
Depression
Description
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
Title
Health-related quality of life
Description
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 Pre-specified Outcome Measures:
Title
Sarcopenia screening
Description
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
Title
Dementia screening
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
65-99 years old
able to walk 6 meters without assistance devices
older adults with possible sarcopenia, sarcopenia or severe sarcopenia
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-Chun Lee, PhD
Phone
0963210548
Email
sclee@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-Chun Lee, PhD
Organizational Affiliation
School of Gerontology Health Management
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community daycare center
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-Chun Lee, PhD
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Interactive Exergame in Older Adults With Sarcopenia
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