SarcopeniaNCT03809104
VR-based Rehabilitation in the Treatment and Prevention of Sarcopenia of Older Residents
A study testing Virtual reality-based rehabilitation programs in people with Sarcopenia, run by Cishan Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
Trial summary
Background: Sarcopenia is the progressive loss of skeletal muscle mass and decline of muscle function associated with aging. The prevalence of sarcopenia among people older than 65 years old in Taiwan is over 20%. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Virtual reality-based rehabilitation programs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Jan 2019to 8 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All the rehabilitation subjects are selected from the nursing home and day care center of Chi-Shan Hospital and over 60 years of age.
- Participants meet the diagnostic criteria of sarcopenia based on the The Asian Working Group of Sarcopenia:
- Muscle mass lower than norm for two standard deviations and (2) Grip strength: men lower than 26 kg and women lower than 18 kg (measured by handgrip denominator used in physical examination) or an average gait speed lower than 0.8m/ sec.
- 3. Cognitive functions and physical strength are capable of completing the rehabilitation program which lasts for 30 minutes
Who cannot join
- The ones who have uncontrollable high blood pressure, are recently infected, have major cardiovascular diseases and are prohibited to participate in sports exercise by the American College of Sports Medicine are excluded from the selection.
- The ones who are bedridden are excluded from the selection.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Cishan Hospital, Ministry of health and welfare
Kaohsiung City, 84247
About this study
Official title: Virtual Reality-based Rehabilitation in the Treatment and Prevention of Sarcopenia of Older Residents in Caring Facilities - a Pilot Study in Rural Southern Taiwan
Background:
Sarcopenia is the progressive loss of skeletal muscle mass and decline of muscle function associated with aging. The prevalence of sarcopenia among people older than 65 years old in Taiwan is over 20%. Sarcopenia is one of the most important causes of functional decline and loss of independence, even mortality in older adults. Literatures have found that resistant or aerobic exercise could improve muscle strength and function in older adults. However, due to shortage in healthcare provider, long-term rehabilitation program is difficult to provide in senior caring facilities of countryside in Taiwan.
Read more
Method:
The investigators conducted a study to screen sarcopenia among residents in senior caring facilities in Ci-Shan and Mei-Nong district, Kaohsiung, Taiwan. Older adults diagnosed as sarcopenia after screening received a virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. Criteria of sarcopenia including (1) handgrip strength of dominant hand (HGS), (2) walking speed, and (3) skeletal muscle mass of 4 extremities (SKM), were measured as primary outcomes. (1) Range of motions in dominant UE (ROM), (2) maximal voluntary isometric contraction of biceps/triceps brachial muscles of dominant side (MVC of biceps/triceps), and (3) box and block test (BBT), were measured as secondary outcomes before and after the programs.
Anticipated benefits:
VR-based rehabilitation program could enhance the motivation toward rehabilitation of older adults and reduce the health provider demand of senior caring facilities in countryside. It could also increase muscle mass, strength, and functional ability of dominant UE and reach the clinical effectiveness in treatment of sarcopenia.
Read the detailed description
Sarcopenia is an involuntary loss of skeletal muscle mass and strength related with age. It is one of the most important causes of functional decline and loss of independence in older adults. In Taiwan, more than 20% of elders over the age of 65 are diagnosed with sarcopenia, and most of them are institutionalized. However, due to the lack of medical resources and medical professions, only a few elders with sarcopenia have received adequate rehabilitation. Recently, there are prevalence of research about integrating Virtual-Reality (VR) into various rehabilitations. Most of them have found that these VR-based rehabilitation can boost the motivation for participation, decrease the use of medical resources, and effectively contribute to the recovery of the patients. Inspired from these results, I think it might be interesting to integrate VR into the sarcopenia rehabilitation of elders.
This research has combined existed VR games with progressive resistance exercise of the upper limbs and exercises for the function movement system (F.M.S) of the upper limbs, establishing a VR-based rehabilitation program designed for sarcopenia elders. The rehabilitation programs spans for 8 weeks, and is conducted at least twice a week for each subject. The research question of this research is: "What is the impact of Virtual Reality-based rehabilitation on upper limb sarcopenia patient?".
The primary outcome of this research examines the change in muscle mass (measured by skeletal mass index, fat mass index and fat-free mass index), hand grip strength of the dominant hand and gait speed. The secondary outcome of this research examines the the change in range of motion of the upper limbs (shoulder flexion, shoulder external rotation, shoulder abduction, elbow flexion, elbow extension, elbow supination, elbow pronation, wrist flexion, wrist extension) and the functional ability of the upper limbs (measured by box and block test).
Hypothesis:
- After two months of participating in the rehabilitation program, the primary outcomes (muscle mass, hand grip strength, and gait speed), show statistically significant increase.
- After two months of participating in the rehabilitation program, the secondary outcomes (change of range of motion of the upper limbs and functional ability of upper limbs) show statistically significant increase.
Flow of the research:
- Sarcopenia patients are first selected from the daycare and nursing home of Chi-Shan Hospital.
- The first period of rehabilitation begins right after the selection and lasts for one month.
- The first evaluation begins after the first period of rehabilitation
- The second period of rehabilitation begins and lasts for one month.
- The second evaluation begins after the second period of rehabilitation.
Apparatus in this study:
- Leap Motion Controller
- Oculus Rift headset (CV1)
- Oculus Sensors (a pair)
- (oculus) Touch Controllers
- Omron KARADA Scan Body Composition \& Scale (HBF-701)
- JAMAR Hand Dynamometer
- MicroFET3 Dynamometer and ROM Evaluator
- Goniometer
- Box and Block Test Apparatus
- Conditions
- Sarcopenia
- Being tested
- Virtual reality-based rehabilitation programs
- Keywords
- virtual reality, sarcopenia, elderly
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality-based rehabilitation programsOther
A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.
| Study group | Role | What they receive |
|---|---|---|
| elderly with sarcopenia | Experimental | Virtual reality-based rehabilitation programs Receives: Other: Virtual reality-based rehabilitation programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Hand-grip Strength of the Dominant Hand Between the Third Month and the Baseline
The measurements of the HGS were determined by means of the JAMAR-Dynamometer. The forearm was held in neutral position and the wrist at a 0 to 30° extension. The instrument was held freely: neither the hand nor the forearm was allowed to rest on a surface. Three measurements were done and recorded as the average of the three measurements and the participants rested for 1 minute in between measurements.
The change was calculated by the data of the third month minus the baseline data.
Measured: 3 months after the intervention of the virtual reality-based rehabilitation programs
Change of Walking Speed Between the Third Month and the Baseline
Timing starts after the patient starts walking and stops at the point when a patient reaches a distance of 6 meters. The gait speed in measured twice and the final measurement is the average of the two scores. The patient is allowed to rest for 10 minutes in between measurement.
The change was calculated by the data of the third month minus the baseline data.
Measured: 3 months after the intervention of the virtual reality-based rehabilitation programs
Change of Appendicular Skeletal Muscle Mass Between the Third Month and the Baseline
Appendicular skeletal muscle mass (ASM) is defined by the sum of the lean soft tissue mass of four limbs. Appendicular skeletal muscle mass index (ASMI) is defined as ASM (kg) divided by squared height (m).The body composition was measured via bio-electrical impedance analysis by Omron KARADA Scan Body Composition \& Scale (HBF-701). A participant was considered to have low muscle mass if his or her ASMI was below -2 standard deviations of the reference defined in previous studies from Taiwan (6.76 kg/m2 for men and 5.28 kg/m2 for women). Participants with ASMI in the lowest 20% of the sex-specific distribution were considered to have low muscle mass, too. Increased of ASMI after virtual reality-based rehabilitation programs is considered to be better.
The change was calculated by the data of the third month minus the baseline data.
Measured: 3 months after the intervention of the virtual reality-based rehabilitation programs
Secondary outcomes (3)
Range of Motions in Dominant Upper Extremity
Use goniometry for range of motion measurement. The joints measured include shoulder, elbow, and wrist of the dominant side.
Measured: baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs
Strength of Biceps Brachii and Triceps Brachii of the Dominant Upper Extremity
This research uses MicroFET3 to measure the the maximal voluntary isometric contraction of the biceps and triceps. Measurements are taken 2 times and the results are averaged. MicroFET3 is a electronic hand-held dynamometer that can measure muscle strength. The range of muscle testing of the device ranges from 0-150 lbs force.(Digital Dynamometer and Inclinometer | MicroFET®3) .
Measured: baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs
Box and Block Test
The Box and Block Test (BBT) can measure the unilateral gross manual dexterity. The set up of the BBT test includes a wooden box with 150 wooden blocks inside. The wooden box is divided into two compartments. One filled with blocks, and the other is empty.During this test, the patient is seated upright in a chair and needs to transfer the wooden blocks, one by one, from one compartment to the other. The patient is scored based on the number of blocks he or she can transferred from one compartment to the other in 60 seconds.
Measured: baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start3 Jan 2019
- Primary completion6 Sep 2019
- Study completion8 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- elder residents in caring facilities, including nursing home and daycare center 15 participants in nursing home and 15 participants in daycare center
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cishan Hospital, Ministry of Health and Welfare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Hui Tuan, Cishan Hospital, Ministry of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809104
- Sponsor's protocol ID
- 18-034
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2019
- Last updated
- 21 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ali S, Garcia JM. Sarcopenia, cachexia and aging: diagnosis, mechanisms and therapeutic options - a mini-review. Gerontology. 2014;60(4):294-305. doi: 10.1159/000356760. Epub 2014 Apr 8.
PubMed 24731978Frontera WR, Hughes VA, Fielding RA, Fiatarone MA, Evans WJ, Roubenoff R. Aging of skeletal muscle: a 12-yr longitudinal study. J Appl Physiol (1985). 2000 Apr;88(4):1321-6. doi: 10.1152/jappl.2000.88.4.1321.
PubMed 10749826Lexell J. Human aging, muscle mass, and fiber type composition. J Gerontol A Biol Sci Med Sci. 1995 Nov;50 Spec No:11-6. doi: 10.1093/gerona/50a.special_issue.11.
PubMed 7493202Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.
PubMed 12028177Janssen I, Shepard DS, Katzmarzyk PT, Roubenoff R. The healthcare costs of sarcopenia in the United States. J Am Geriatr Soc. 2004 Jan;52(1):80-5. doi: 10.1111/j.1532-5415.2004.52014.x.
PubMed 14687319Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.
PubMed 24461239Lo YC, Wahlqvist ML, Huang YC, Chuang SY, Wang CF, Lee MS. Medical costs of a low skeletal muscle mass are modulated by dietary diversity and physical activity in community-dwelling older Taiwanese: a longitudinal study. Int J Behav Nutr Phys Act. 2017 Mar 14;14(1):31. doi: 10.1186/s12966-017-0487-x.
PubMed 28288651Yarasheski KE, Pak-Loduca J, Hasten DL, Obert KA, Brown MB, Sinacore DR. Resistance exercise training increases mixed muscle protein synthesis rate in frail women and men >/=76 yr old. Am J Physiol. 1999 Jul;277(1):E118-25. doi: 10.1152/ajpendo.1999.277.1.E118.
PubMed 10409135Chen KM, Li CH, Chang YH, Huang HT, Cheng YY. An elastic band exercise program for older adults using wheelchairs in Taiwan nursing homes: a cluster randomized trial. Int J Nurs Stud. 2015 Jan;52(1):30-8. doi: 10.1016/j.ijnurstu.2014.06.005. Epub 2014 Jun 19.
PubMed 25037651Liu CJ, Latham NK. Progressive resistance strength training for improving physical function in older adults. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD002759. doi: 10.1002/14651858.CD002759.pub2.
PubMed 19588334Park DS, Lee DG, Lee K, Lee G. Effects of Virtual Reality Training using Xbox Kinect on Motor Function in Stroke Survivors: A Preliminary Study. J Stroke Cerebrovasc Dis. 2017 Oct;26(10):2313-2319. doi: 10.1016/j.jstrokecerebrovasdis.2017.05.019. Epub 2017 Jun 9.
PubMed 28606661Ilg W, Schatton C, Schicks J, Giese MA, Schols L, Synofzik M. Video game-based coordinative training improves ataxia in children with degenerative ataxia. Neurology. 2012 Nov 13;79(20):2056-60. doi: 10.1212/WNL.0b013e3182749e67. Epub 2012 Oct 31.
PubMed 23115212Garcia JA, Felix Navarro K, Schoene D, Smith ST, Pisan Y. Exergames for the elderly: towards an embedded Kinect-based clinical test of falls risk. Stud Health Technol Inform. 2012;178:51-7.
PubMed 22797019Bohannon RW. Test-retest reliability of the MicroFET 4 hand-grip dynamometer. Physiother Theory Pract. 2006 Sep;22(4):219-21. doi: 10.1080/09593980600822875.
PubMed 16920680Stark T, Walker B, Phillips JK, Fejer R, Beck R. Hand-held dynamometry correlation with the gold standard isokinetic dynamometry: a systematic review. PM R. 2011 May;3(5):472-9. doi: 10.1016/j.pmrj.2010.10.025.
PubMed 21570036
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality-based Rehabilitation in the Treatment and Prevention of Sarcopenia of Older Residents in Caring Facilities - a Pilot Study in Rural Southern Taiwan
- ClinicalTrials.gov ID
- NCT03809104
- Acronym / sponsor ID
- 18-034
- Conditions
- Sarcopenia
- Keywords
- virtual reality, sarcopenia, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Cishan Hospital, Ministry of Health and WelfareUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 8 Oct 2019 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Posted 21 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Sarcopenia is the progressive loss of skeletal muscle mass and decline of muscle function associated with aging. The prevalence of sarcopenia among people older than 65 years old in Taiwan is over 20%. Sarcopenia is one of the most important causes of functional decline and loss of independence, even mortality in older adults. Literatures have found that resistant or aerobic exercise could improve muscle strength and function in older adults. However, due to shortage in healthcare provider, long-term rehabilitation program is difficult to provide in senior caring facilities of countryside in Taiwan.
Method:
The investigators conducted a study to screen sarcopenia among residents in senior caring facilities in Ci-Shan and Mei-Nong district, Kaohsiung, Taiwan. Older adults diagnosed as sarcopenia after screening received a virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. Criteria of sarcopenia including (1) handgrip strength of dominant hand (HGS), (2) walking speed, and (3) skeletal muscle mass of 4 extremities (SKM), were measured as primary outcomes. (1) Range of motions in dominant UE (ROM), (2) maximal voluntary isometric contraction of biceps/triceps brachial muscles of dominant side (MVC of biceps/triceps), and (3) box and block test (BBT), were measured as secondary outcomes before and after the programs.
Anticipated benefits:
VR-based rehabilitation program could enhance the motivation toward rehabilitation of older adults and reduce the health provider demand of senior caring facilities in countryside. It could also increase muscle mass, strength, and functional ability of dominant UE and reach the clinical effectiveness in treatment of sarcopenia.
Detailed description
Sarcopenia is an involuntary loss of skeletal muscle mass and strength related with age. It is one of the most important causes of functional decline and loss of independence in older adults. In Taiwan, more than 20% of elders over the age of 65 are diagnosed with sarcopenia, and most of them are institutionalized. However, due to the lack of medical resources and medical professions, only a few elders with sarcopenia have received adequate rehabilitation. Recently, there are prevalence of research about integrating Virtual-Reality (VR) into various rehabilitations. Most of them have found that these VR-based rehabilitation can boost the motivation for participation, decrease the use of medical resources, and effectively contribute to the recovery of the patients. Inspired from these results, I think it might be interesting to integrate VR into the sarcopenia rehabilitation of elders.
This research has combined existed VR games with progressive resistance exercise of the upper limbs and exercises for the function movement system (F.M.S) of the upper limbs, establishing a VR-based rehabilitation program designed for sarcopenia elders. The rehabilitation programs spans for 8 weeks, and is conducted at least twice a week for each subject. The research question of this research is: "What is the impact of Virtual Reality-based rehabilitation on upper limb sarcopenia patient?".
The primary outcome of this research examines the change in muscle mass (measured by skeletal mass index, fat mass index and fat-free mass index), hand grip strength of the dominant hand and gait speed. The secondary outcome of this research examines the the change in range of motion of the upper limbs (shoulder flexion, shoulder external rotation, shoulder abduction, elbow flexion, elbow extension, elbow supination, elbow pronation, wrist flexion, wrist extension) and the functional ability of the upper limbs (measured by box and block test).
Hypothesis:
- After two months of participating in the rehabilitation program, the primary outcomes (muscle mass, hand grip strength, and gait speed), show statistically significant increase.
- After two months of participating in the rehabilitation program, the secondary outcomes (change of range of motion of the upper limbs and functional ability of upper limbs) show statistically significant increase.
Flow of the research:
- Sarcopenia patients are first selected from the daycare and nursing home of Chi-Shan Hospital.
- The first period of rehabilitation begins right after the selection and lasts for one month.
- The first evaluation begins after the first period of rehabilitation
- The second period of rehabilitation begins and lasts for one month.
- The second evaluation begins after the second period of rehabilitation.
Apparatus in this study:
- Leap Motion Controller
- Oculus Rift headset (CV1)
- Oculus Sensors (a pair)
- (oculus) Touch Controllers
- Omron KARADA Scan Body Composition \& Scale (HBF-701)
- JAMAR Hand Dynamometer
- MicroFET3 Dynamometer and ROM Evaluator
- Goniometer
- Box and Block Test Apparatus
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- elder residents in caring facilities, including nursing home and daycare center 15 participants in nursing home and 15 participants in daycare center
| Arm | Type | Receives |
|---|---|---|
| elderly with sarcopenia | Experimental | Other: Virtual reality-based rehabilitation programsVirtual reality-based rehabilitation programs |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All the rehabilitation subjects are selected from the nursing home and day care center of Chi-Shan Hospital and over 60 years of age.
- Participants meet the diagnostic criteria of sarcopenia based on the The Asian Working Group of Sarcopenia:
- Muscle mass lower than norm for two standard deviations and (2) Grip strength: men lower than 26 kg and women lower than 18 kg (measured by handgrip denominator used in physical examination) or an average gait speed lower than 0.8m/ sec.
- 3. Cognitive functions and physical strength are capable of completing the rehabilitation program which lasts for 30 minutes
Key exclusion criteria (2 listed)
- The ones who have uncontrollable high blood pressure, are recently infected, have major cardiovascular diseases and are prohibited to participate in sports exercise by the American College of Sports Medicine are excluded from the selection.
- The ones who are bedridden are excluded from the selection.
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 |
|---|---|---|
| Virtual reality-based rehabilitation programsA virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer. | Other | elderly with sarcopenia |
Primary outcome
Change of Hand-grip Strength of the Dominant Hand Between the Third Month and the Baseline
Time frame: 3 months after the intervention of the virtual reality-based rehabilitation programs
The measurements of the HGS were determined by means of the JAMAR-Dynamometer. The forearm was held in neutral position and the wrist at a 0 to 30° extension. The instrument was held freely: neither the hand nor the forearm was allowed to rest on a surface. Three measurements were done and recorded as the average of the three measurements and the participants rested for 1 minute in between measurements. The change was calculated by the data of the third month minus the baseline data.
Change of Walking Speed Between the Third Month and the Baseline
Time frame: 3 months after the intervention of the virtual reality-based rehabilitation programs
Timing starts after the patient starts walking and stops at the point when a patient reaches a distance of 6 meters. The gait speed in measured twice and the final measurement is the average of the two scores. The patient is allowed to rest for 10 minutes in between measurement. The change was calculated by the data of the third month minus the baseline data.
Change of Appendicular Skeletal Muscle Mass Between the Third Month and the Baseline
Time frame: 3 months after the intervention of the virtual reality-based rehabilitation programs
Appendicular skeletal muscle mass (ASM) is defined by the sum of the lean soft tissue mass of four limbs. Appendicular skeletal muscle mass index (ASMI) is defined as ASM (kg) divided by squared height (m).The body composition was measured via bio-electrical impedance analysis by Omron KARADA Scan Body Composition \& Scale (HBF-701). A participant was considered to have low muscle mass if his or her ASMI was below -2 standard deviations of the reference defined in previous studies from Taiwan (6.76 kg/m2 for men and 5.28 kg/m2 for women). Participants with ASMI in the lowest 20% of the sex-specific distribution were considered to have low muscle mass, too. Increased of ASMI after virtual reality-based rehabilitation programs is considered to be better. The change was calculated by the data of the third month minus the baseline data.
3 secondary outcomes
Range of Motions in Dominant Upper Extremity
Time frame: baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs
Strength of Biceps Brachii and Triceps Brachii of the Dominant Upper Extremity
Time frame: baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs
Box and Block Test
Time frame: baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24731978Ali S, Garcia JM. Sarcopenia, cachexia and aging: diagnosis, mechanisms and therapeutic options - a mini-review. Gerontology. 2014;60(4):294-305. doi: 10.1159/000356760. Epub 2014 Apr 8.
- Background: PubMed 10749826Frontera WR, Hughes VA, Fielding RA, Fiatarone MA, Evans WJ, Roubenoff R. Aging of skeletal muscle: a 12-yr longitudinal study. J Appl Physiol (1985). 2000 Apr;88(4):1321-6. doi: 10.1152/jappl.2000.88.4.1321.
- Background: PubMed 7493202Lexell J. Human aging, muscle mass, and fiber type composition. J Gerontol A Biol Sci Med Sci. 1995 Nov;50 Spec No:11-6. doi: 10.1093/gerona/50a.special_issue.11.
- Background: PubMed 12028177Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.
- Background: PubMed 14687319Janssen I, Shepard DS, Katzmarzyk PT, Roubenoff R. The healthcare costs of sarcopenia in the United States. J Am Geriatr Soc. 2004 Jan;52(1):80-5. doi: 10.1111/j.1532-5415.2004.52014.x.
- Background: PubMed 24461239Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.
- Background: PubMed 28288651Lo YC, Wahlqvist ML, Huang YC, Chuang SY, Wang CF, Lee MS. Medical costs of a low skeletal muscle mass are modulated by dietary diversity and physical activity in community-dwelling older Taiwanese: a longitudinal study. Int J Behav Nutr Phys Act. 2017 Mar 14;14(1):31. doi: 10.1186/s12966-017-0487-x.
- Background: PubMed 10409135Yarasheski KE, Pak-Loduca J, Hasten DL, Obert KA, Brown MB, Sinacore DR. Resistance exercise training increases mixed muscle protein synthesis rate in frail women and men >/=76 yr old. Am J Physiol. 1999 Jul;277(1):E118-25. doi: 10.1152/ajpendo.1999.277.1.E118.
- Background: PubMed 25037651Chen KM, Li CH, Chang YH, Huang HT, Cheng YY. An elastic band exercise program for older adults using wheelchairs in Taiwan nursing homes: a cluster randomized trial. Int J Nurs Stud. 2015 Jan;52(1):30-8. doi: 10.1016/j.ijnurstu.2014.06.005. Epub 2014 Jun 19.
- Background: PubMed 19588334Liu CJ, Latham NK. Progressive resistance strength training for improving physical function in older adults. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD002759. doi: 10.1002/14651858.CD002759.pub2.
- Background: PubMed 28606661Park DS, Lee DG, Lee K, Lee G. Effects of Virtual Reality Training using Xbox Kinect on Motor Function in Stroke Survivors: A Preliminary Study. J Stroke Cerebrovasc Dis. 2017 Oct;26(10):2313-2319. doi: 10.1016/j.jstrokecerebrovasdis.2017.05.019. Epub 2017 Jun 9.
- Background: PubMed 23115212Ilg W, Schatton C, Schicks J, Giese MA, Schols L, Synofzik M. Video game-based coordinative training improves ataxia in children with degenerative ataxia. Neurology. 2012 Nov 13;79(20):2056-60. doi: 10.1212/WNL.0b013e3182749e67. Epub 2012 Oct 31.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality-based rehabilitation programs in people with Sarcopenia, run by Cishan Hospital, Ministry of Health and Welfare 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 21 Jan 2020. 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?
Yes. Results are posted in the registry (first posted 21 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Hand-grip Strength of the Dominant Hand Between the Third Month and the Baseline (time frame: 3 months after the intervention of the virtual reality-based rehabilitation programs). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03809104, which also lists 15 linked publications.
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 21 Jan 2020.