Efficacy of Virtual Reality Exercises on Sarcopenia in Patients With Liver Transplantation (LT)

This study will be conducted to investigate the effect of virtual reality exercises on hand grip strength, pinch strength, quadriceps muscle strength, exercise capacity, fatigue, and quality of life in patients with liver transplantation.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Other: Virtual Reality exercise; Other: conventional treatment

Detailed Description

Liver transplantation (LT) continues to prove to be the best choice for curing patients with end-stage liver disease (ESLD) . Management strategies in peri-transplantation care have significantly improved the outcomes of patients after LT. One of the most challenging tasks of LT is defining which patients are clinically appropriate for this therapy. Evaluating disease severity for patients with ESLD is a serious challenge for liver transplant surgeons, and there is a critical need for better methods of risk stratification. The most common complications involved include ascites, hepatic encephalopathy, and variceal bleeding; however, severe muscle wasting or sarcopenia is the most common and frequently undiagnosed complications that negatively impact survival, quality of life, and response to stressors, such as infections and surgeries. Virtual reality (VR) is an interactive, 3-dimensional computer experience occurring in real time. It allows the users to participate in multisensory and multidimensional virtual environments . It provides the participants with real-time auditory, visual, and proprioception sensory feedback. It also provides a safe virtual exercise environment. sixty patients with liver transplantation will be assigned randomly to two groups; experimental group will receive virtual reality exercise plus traditional therapy for six weeks, control group will receive traditional therapy alone for six weeks

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sata A Elshrief, Bsc; Phone Number: +2 01065095990; Email: ssyara14@yahoo.com
• Study Contact Backup: Name: Nabil M Ismail, Assist. Prof; Phone Number: +2 0120133613; Email: nabil.mahmoud@cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of physical therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Sixty patients suffer from sarcopenia with liver transplantation. The age of patients ranges from (18:65) years. All patients must be conscious. Patients suffer from muscle weakness Patients suffer from fatigue Patients with low muscle endurance Patients' cases must be stable to deal with them

Exclusion Criteria:

Patients will be excluded if they have any of the following:

Any sign of acute rejection of the transplanted organ Acute hemorrhage Electrolyte imbalance Physiological instability Sever neurologic complication Sever cardiovascular co-morbidities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: virtual reality exercise; the patients will receive virtual reality and conventional therapy three times a week for six weeks	Other: Virtual Reality exercise; after explaining the treatment method for patients, the patients will perform full body aerobic exercise by applying kick boxing to destroy walls of rock; the patient moves most of body muscles in this game. He or she flex and extend the shoulder and the elbow with flexion and extension in the knee. squatting exercise, endurance exercise, coordination for arm and shoulder exercise will also performed in virtual reality; Other: conventional treatment; the patients will receive conventional treatment in the form of aerobic exercise, resistance exercise and endurance exercise.
Experimental: conventional treatment; the patients will receive conventional treatment three times a week for six weeks	Other: conventional treatment; the patients will receive conventional treatment in the form of aerobic exercise, resistance exercise and endurance exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand grip strength	JAMAR hand grip dynamometer will be used to measure hand grip strength	up to six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pinch strength	JAMAR Pinch grip dynamometer will be used to measure pinch strength	up to six weeks
Respiratory function	spirometry will be used to measure the the ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC)	up to six weeks
Fatigue	Arabic version of fatigue severity scale will be used to measure fatigue. It consists of 9 items , patients score each item from 1 to 7, based on the extent, to which they agree or disagree with each statement (1 = strong disagreement, 7 = strong agreement). The FSS can be scored either by obtaining a total score, or by calculating a mean score across all 9 items, with higher scores indicating more severe fatigue.	up to six weeks
life disability	The World Health Organization Quality of Life - BREF (WHOQOL-BREF) will be used to assess quality of life.The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale.	up to six weeks
exercise capacity	six minute walk test will be used to assess the exercise capacity.The 6-minute walk test requires a subject to walk as far as he or she can in 6 minutes, with rests as needed.	up to six weeks
quadriceps strength	hand-held dynamometer (HHD) ( Lafayette Instrument Company, USA) will be used to assess quadriceps strength. it is a reliable strength testing equipment. It is a portable device that can be used to obtain more discrete, objective measures of strength during manual muscle testing	up to six weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Sara A Elshrief, Bsc, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): January 25, 2024
• Primary Completion (Estimated): June 20, 2024
• Study Completion (Estimated): June 20, 2024

Study Registration Dates

• First Submitted: December 28, 2023
• First Submitted That Met QC Criteria: January 13, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 13, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; liver transplantation; virtual reality
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: P.T.REC/012/003915

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No