Clinical trial NCT03809104: VR-based Rehabilitation in the Treatment and Prevention of Sarcopenia of Older Residents
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: virtual reality
sarcopenia
elderly
Lead sponsor: Cishan Hospital, Ministry of Health and Welfare
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 43
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: elder residents in caring facilities, including nursing home and daycare center 15 participants in nursing home and 15 participants in daycare center
Primary purpose: PREVENTION

Brief 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.

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:

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change of Hand-grip Strength of the Dominant Hand Between the Third Month and the Baseline
timeFrame: 3 months after the intervention of the virtual reality-based rehabilitation programs
measure: Change of Walking Speed Between the Third Month and the Baseline
timeFrame: 3 months after the intervention of the virtual reality-based rehabilitation programs
measure: Change of Appendicular Skeletal Muscle Mass Between the Third Month and the Baseline
timeFrame: 3 months after the intervention of the virtual reality-based rehabilitation programs
Secondary outcomes:
measure: Range of Motions in Dominant Upper Extremity
timeFrame: baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs
measure: Strength of Biceps Brachii and Triceps Brachii of the Dominant Upper Extremity
timeFrame: baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs
measure: Box and Block Test
timeFrame: baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Cishan Hospital, Ministry of health and welfare
Study officials:
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