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

NCT ID: NCT03809104

Last Updated: 2020-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-03
• Study Completion Date: 2019-10-08

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

Conditions

Sarcopenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

elderly with sarcopenia

Virtual reality-based rehabilitation programs

Group Type: EXPERIMENTAL

Virtual reality-based rehabilitation programs

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cishan Hospital, Ministry of Health and Welfare

OTHER

Sponsor Role: lead

Responsible Party

Sheng-Hui Tuan

Attending Physician of Department of Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cishan Hospital, Ministry of health and welfare

Kaohsiung City, , Taiwan

Countries

Taiwan

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

18-034

Identifier Type: -

Identifier Source: org_study_id