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

NCT03809104 | Completed Results

• 1 other identifier: 18-034
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

virtual reality; sarcopenia; elderly

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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.

  3 months after the intervention of the virtual reality-based rehabilitation programs

Secondary Outcomes (3)

• Range of Motions in Dominant Upper Extremity

  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

  baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs

• Box and Block Test

  baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs

Study Arms (1)

elderly with sarcopenia

EXPERIMENTAL

Virtual reality-based rehabilitation programs

Other: Virtual reality-based rehabilitation programs

Interventions

Virtual reality-based rehabilitation programs 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.

elderly with sarcopenia

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• (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.
• \. Cognitive functions and physical strength are capable of completing the rehabilitation program which lasts for 30 minutes

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cishan Hospital, Ministry of Health and Welfare: lead

Study Sites (1)

Cishan Hospital, Ministry of health and welfare

Kaohsiung City, 84247, Taiwan

Location

Related Publications (15)

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MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Results Point of Contact

• Title: Ms. Chia-Yu Wei
• Organization: Ci-Shan Hospital, Health and Welfare of Minister, Taiwan

ivywei@chis.mohw.gov.tw

+886-7-6615523

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician of Department of Rehabilitation

Model Details: elder residents in caring facilities, including nursing home and daycare center 15 participants in nursing home and 15 participants in daycare center

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 18, 2019
• Study Start: January 3, 2019
• Primary Completion: September 6, 2019
• Study Completion: October 8, 2019
• Last Updated: January 21, 2020
• Results First Posted: January 21, 2020

Record last verified: 2020-01

Locations

TW (1)