VR-based Rehabilitation in the Treatment and Prevention of Sarcopenia of Older Residents

Sarcopenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03809104
• Other study ID #: 18-034
• Status: Completed
• Phase: N/A
• Start date: January 3, 2019
• Est. completion date: October 8, 2019

Study information

• Verified date: January 2020
• Source: Cishan Hospital, Ministry of Health and Welfare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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%. 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.

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:

1. After two months of participating in the rehabilitation program, the primary outcomes (muscle mass, hand grip strength, and gait speed), show statistically significant increase.

2. 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:

1. Sarcopenia patients are first selected from the daycare and nursing home of Chi-Shan Hospital.

2. The first period of rehabilitation begins right after the selection and lasts for one month.

3. The first evaluation begins after the first period of rehabilitation

4. The second period of rehabilitation begins and lasts for one month.

5. The second evaluation begins after the second period of rehabilitation.

Apparatus in this study:

1. Leap Motion Controller

2. Oculus Rift headset (CV1)

3. Oculus Sensors (a pair)

4. (oculus) Touch Controllers

5. Omron KARADA Scan Body Composition & Scale (HBF-701)

6. JAMAR Hand Dynamometer

7. MicroFET3 Dynamometer and ROM Evaluator

8. Goniometer

9. Box and Block Test Apparatus

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 8, 2019
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

Inclusion Criteria:

1. All the rehabilitation subjects are selected from the nursing home and day care center of Chi-Shan Hospital and over 60 years of age.

2. Participants meet the diagnostic criteria of sarcopenia based on the The Asian Working Group of Sarcopenia:

(1) 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

Exclusion Criteria:

1. 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.

2. The ones who are bedridden are excluded from the selection.

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Other:
• Virtual reality-based rehabilitation programs
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.

Locations

Country	Name	City	State
Taiwan	Cishan Hospital, Ministry of health and welfare	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Cishan Hospital, Ministry of Health and Welfare

Country where clinical trial is conducted

Taiwan, 

References & Publications (15)

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months after the intervention of the virtual reality-based rehabilitation programs
Primary	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.	3 months after the intervention of the virtual reality-based rehabilitation programs
Primary	Change of Appendicular Skeletal Muscle Mass Between the Third Month and the Baseline	Appendicular skeletal muscle mass (ASM) is de?ned 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 months after the intervention of the virtual reality-based rehabilitation programs
Secondary	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.	baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs
Secondary	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) .	baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs
Secondary	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.	baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs