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

Not Applicable

Not yet recruiting

• Conditions: Sarcopenia
• Interventions: Other: conventional treatment; Other: Virtual Reality exercise

• Registration Number: NCT06209073
• Lead Sponsor: Cairo University

Brief Summary

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.

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 Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-12-28
• Study First Submitted QC: 2024-01-13
• Last Update Submitted: 2024-01-13
• Study First Posted: 2024-01-17
• Last Update Posted: 2024-01-17
• Study Start: 2024-01-25
• Primary Completion: 2024-06-20
• Study Completion: 2024-06-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional treatment	conventional treatment	the patients will receive conventional treatment three times a week for six weeks
virtual reality exercise	conventional treatment	the patients will receive virtual reality and conventional therapy three times a week for six weeks
virtual reality exercise	Virtual Reality exercise	the patients will receive virtual reality and conventional therapy three times a week for six weeks

Primary Outcome Measures

Name	Time	Method
Hand grip strength	up to six weeks	JAMAR hand grip dynamometer will be used to measure hand grip strength

Secondary Outcome Measures

Name	Time	Method
Respiratory function	up to six weeks	spirometry will be used to measure the the ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC)
Fatigue	up to six weeks	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.
exercise capacity	up to six weeks	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.
Pinch strength	up to six weeks	JAMAR Pinch grip dynamometer will be used to measure pinch strength
life disability	up to six weeks	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.
quadriceps strength	up to six weeks	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

Trial Locations

Locations (1)

Faculty of Physical Therapy; 🇪🇬 Cairo, Egypt