NCT06209073

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

January 25, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

December 28, 2023

Last Update Submit

January 13, 2024

Conditions

Keywords

liver transplantationvirtual realityquality of life

Outcome Measures

Primary Outcomes (1)

  • Hand grip strength

    JAMAR hand grip dynamometer will be used to measure hand grip strength

    up to six weeks

Secondary Outcomes (6)

  • Pinch strength

    up to six weeks

  • Respiratory function

    up to six weeks

  • Fatigue

    up to six weeks

  • life disability

    up to six weeks

  • exercise capacity

    up to six weeks

  • +1 more secondary outcomes

Study Arms (2)

virtual reality exercise

EXPERIMENTAL

the patients will receive virtual reality and conventional therapy three times a week for six weeks

Other: Virtual Reality exerciseOther: conventional treatment

conventional treatment

EXPERIMENTAL

the patients will receive conventional treatment three times a week for six weeks

Other: conventional treatment

Interventions

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

virtual reality exercise

the patients will receive conventional treatment in the form of aerobic exercise, resistance exercise and endurance exercise.

conventional treatmentvirtual reality exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Cairo, Egypt

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sara A Elshrief, Bsc

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sata A Elshrief, Bsc

CONTACT

Nabil M Ismail, Assist. Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
opaque sealed envelop
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: virtual reality and conventional treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator: nabil mahmoud ismail abdel-Aal

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 17, 2024

Study Start

January 25, 2024

Primary Completion

June 20, 2024

Study Completion

June 20, 2024

Last Updated

January 17, 2024

Record last verified: 2023-01

Locations