The Effectiveness of Telerehabilitation in Liver Transplant Patients
Investigation of the Effectiveness of the Telerehabilitation Program in Patients With Liver Transplantation
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Alper AYAS, MSc
- Phone Number: +90 505 952 63 15
- Email: alper.ayas@ogr.iuc.edu.tr
Study Locations
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Istanbul
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Büyükçekmece, Istanbul, Turkey (Türkiye), 34500
- Istanbul University-Cerrahpasa, Faculty of Health Sciences, Physiotherapy and Rehabilitation Laboratory
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Contact:
- Rüstem Mustafaoğlu, associate professor
- Phone Number: +90 555 417 85 35
- Email: rustem.mustafaoglu@iuc.edu.tr
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between 18-65 years of age and having undergone a liver transplant
- Having had a liver transplant operation at least 6 months prior
- Spontaneous breathing
- Hemodynamic stability
- Reading and writing skills
- Ability to mobilize independently, ability to follow verbal and visual instructions
Exclusion Criteria:
- Presence of unstable cardiovascular disease
- Presence of primary lung disease requiring regular bronchodilator treatment
- Presence of neuromuscular disease or neurological complications
- Musculoskeletal limitation/use of assistive devices
- Being a multiple organ transplant recipient
- Presence of orthopedic disability and functional capacity limitation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Home exercise program group
Home exercise program group will initially be given instructions on the exercises and asked to perform them three days a week for eight weeks.
They will be contacted by phone once a week to inquire whether they are doing the exercises.
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Patients will be given brochures on breathing, strengthening, balance and walking exercises and asked to perform them without a physiotherapist.
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Experimental: Telerehabilitation group
The telerehabilitation group will receive videoconference-based telerehabilitation three days a week for eight weeks.
All exercises will be performed under the supervision of a physiotherapist.
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The telerehabilitation program will include breathing, strengthening, balance, and walking exercises, with increasing intensity week by week, and stretching exercises targeting major muscles will be given during the cool-down period.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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6-Minute Walk Test
Time Frame: eight weeks
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Exercise capacity will be assessed using the Six-Minute Walk Test, which plays an important role in evaluating pre- and post-operative exercise performance in liver transplant patients.
The test will be conducted in a 30 m long, enclosed, straight corridor under the supervision of a physiotherapist, in accordance with the criteria set by the American Thoracic Society.
The patients' heart rate and peripheral capillary oxygen saturation values will be recorded before, during, and after the test using a portable pulse oximeter.
Dyspnea and perceived fatigue levels will be assessed using the Modified Borg Scale (MBS) during the test.
The total walking distance completed in six minutes will be recorded in meters as the individual's six-minute walk distance
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eight weeks
|
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Timed Up and Go Test
Time Frame: eight weeks
|
Used to evaluate the balance performance of individuals during movement.
The person sits in a chair of standard height (46 cm), a distance of 3 meters is measured from the chair and a cone is placed at the end of this distance to indicate it.
After receiving the command "walk as fast as you can and sit back down in the chair," the person gets up, walks down the corridor for meters, turns around, walks back to the chair and sits down.
The time from the moment of getting up from the chair until the person turns around and sits back down in the chair is measured with a stopwatch and recorded in seconds.
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eight weeks
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Liver Disease Symptom Index 2.0
Time Frame: eight weeks
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The Chronic Liver Disease Quality of Life Scale 2.0 will be used as a disease-specific measurement tool.
It is a scale developed to objectively evaluate the clinical and psychological consequences on physical and daily living activities in chronic liver disease and to determine the severity of the disease.
The Chronic Liver Disease Quality of Life Scale 2.0 , which has been applied in different stages of chronic liver diseases and psychometrically tested, evaluates the effects of symptoms on daily life as well as symptom severity.
It is a useful and practical scale in clinical use, whose validity and reliability have been established in the Turkish population
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eight weeks
|
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The Fatigue Severity Scale
Time Frame: eight weeks
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The Fatigue Severity Scale (FSS) is a nine-item self-administered scale.
The scale correlates moderately well with the Visual Analog Scale (VAS) and is therefore a good tool for assessing the severity of fatigue.
Patients are asked to choose a number from 1 to 7 indicating how much they agree or disagree with the statement.
"1 point" indicates strong disagreement, "7 points" indicates strong agreement.
A score of 4 and above generally indicates severe fatigue.
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eight weeks
|
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Respiratory Muscle Strength Measurement
Time Frame: eight weeks
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Respiratory muscle strength will be assessed by measuring the maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), which are intraoral pressure measurements.
The measurement will be performed using a portable intraoral pressure gauge with the maximal breathing method while the airway is closed with a valve.
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eight weeks
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Muscle Strength Measurement
Time Frame: eight weeks
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This is a method used to measure muscle strength in patients.
A La Fayette handheld digital dynamometer will be used during the test.
To obtain isometric contraction during the test, the person performing the measurement is asked to hold the dynamometer steady while the person being tested applies maximum contraction against the device.
The patient will be asked to hold the maximal isometric contraction for 5 seconds, followed by a 30-second rest interval and the same procedure will be repeated 3 times on the dominant side and the average of the measurement values will be recorded.
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eight weeks
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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- IUC-FTR-AA-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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