SarcopeniaLTNCT06209073
Efficacy of Virtual Reality Exercises on Sarcopenia in Patients With Liver Transplantation
A study testing Virtual Reality exercise and conventional treatment in people with Sarcopenia, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Virtual Reality exercise and conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2024to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Sarcopenia
- Being tested
- Virtual Reality exercise, conventional treatment
- Keywords
- liver transplantation, virtual reality, quality of life
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality exerciseOther
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
conventional treatmentOther
the patients will receive conventional treatment in the form of aerobic exercise, resistance exercise and endurance exercise.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality exercise | Experimental | the patients will receive virtual reality and conventional therapy three times a week for six weeks Receives: Other: Virtual Reality exercise; Other: conventional treatment |
| conventional treatment | Experimental | the patients will receive conventional treatment three times a week for six weeks Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
JAMAR hand grip dynamometer will be used to measure hand grip strength
Measured: up to six weeks
Secondary outcomes (6)
Pinch strength
JAMAR Pinch grip dynamometer will be used to measure pinch strength
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: up to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start25 Jan 2024 (estimated)
- Primary completion20 Jun 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- virtual reality and conventional treatment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabil Mahmoud Ismail Abdel-Aal, Cairo University
- Investigators
- Sara A Elshrief, Bsc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209073
- Sponsor's protocol ID
- P.T.REC/012/003915
- Acronym
- LT
- Status last verified
- Jan 2023
- First submitted
- 28 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Virtual Reality Exercises on Sarcopenia in Patients With Liver Transplantation
- ClinicalTrials.gov ID
- NCT06209073
- Acronym / sponsor ID
- LT / P.T.REC/012/003915
- Conditions
- Sarcopenia
- Keywords
- liver transplantation, virtual reality, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jan 2024 (estimated)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- virtual reality and conventional treatment
| Arm | Type | Receives |
|---|---|---|
| virtual reality exercise | Experimental | Other: Virtual Reality exercise, Other: conventional treatmentthe patients will receive virtual reality and conventional therapy three times a week for six weeks |
| conventional treatment | Experimental | Other: conventional treatmentthe patients will receive conventional treatment three times a week for six weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Any sign of acute rejection of the transplanted organ Acute hemorrhage Electrolyte imbalance Physiological instability Sever neurologic complication Sever cardiovascular co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality exerciseafter 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 | virtual reality exercise |
| conventional treatmentthe patients will receive conventional treatment in the form of aerobic exercise, resistance exercise and endurance exercise. | Other | conventional treatment, virtual reality exercise |
Primary outcome
Hand grip strength
Time frame: up to six weeks
JAMAR hand grip dynamometer will be used to measure hand grip strength
6 secondary outcomes
Pinch strength
Time frame: up to six weeks
Respiratory function
Time frame: up to six weeks
Fatigue
Time frame: up to six weeks
life disability
Time frame: up to six weeks
exercise capacity
Time frame: up to six weeks
quadriceps strength
Time frame: up to six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara A Elshrief, Bsc principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality exercise and conventional treatment in people with Sarcopenia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sata A Elshrief, Bsc (01065095990 ext. +2, ssyara14@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand grip strength (time frame: up to six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.