- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06563570
The Effect of Teleyoga in Liver Transplant Patients
The Effect of Teleyoga on Balance, Frailty, Cognition and Quality of Life in Liver Transplant Patients
Study Overview
Detailed Description
The study will include liver transplant patients who applied to Dokuz Eylül University Faculty of Medicine, Department of Surgical Medical Sciences, Department of General Surgery Outpatient Clinic. The aim of the study is to investigate the effect of online yoga practice on balance, frailty, cognition and quality of life levels in liver transplant patients. The study will include 26 patients with liver transplantation who meet the criteria. Participants will first be informed about the study and individuals will be included in the study after signing the informed consent form. Demographic information of liver transplant patients will be obtained and their balance, frailty, cognition and quality of life levels and post-transplant symptoms (symptoms seen in people) will be evaluated.
Online yoga practices will be applied to liver transplant patients for 8 weeks, 2 days a week, 30 minutes a day. Online yoga (teleyoga) will be performed via video call with people who meet the inclusion criteria. After 8 weeks of yoga intervention, balance, frailty, cognition and quality of life levels and post-transplant symptoms will be re-evaluated.
Balance measurements will be evaluated with Biodex Balance System (BSS). Frailty levels will be assessed by Short Physical Performance Battery and FRAIL frailty questionnaire. Cognition will be assessed by trail making test and stroop test. Quality of life will be evaluated with Short Form-36 quality of life scale and post-transplantation symptoms will be evaluated with Modified Post-Transplantation Symptom Occurrence and Discomfort Status-58-Item Scale-Turkey.
The evaluations are planned to last 1-2 hours.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
İzmir
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Izmir, İzmir, Turkey (Türkiye), 35160
- Dokuz Eylul University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between the ages of 18-65
- Liver transplantation at least 6 months ago
- Individuals with a Mini Mental Test score greater than 24
Exclusion Criteria:
- Pregnancy
- Central Nervous System Dysfunction
- Musculoskeletal deformity
- Vestibular dysfunction
- Specific neurological pathology (Parkinson's, stroke, epilepsy)
- Those with severe systemic diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: treatment group
The only group in the study was liver transplant patients who practised yoga online.
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8-week online yoga practices, 2 days a week
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biodex Balance System
Time Frame: two weeks
|
Balance will be assessed separately with the Biodex Balance System (Biodex Medical Systems, Inc., Shirley, NY) standing, eyes open, static and dynamic.
For static and dynamic balance assessments, each test will be performed for 20 seconds with 3 repetitions.
Average scores will be recorded after the evaluation.
An increase in scores indicates worsening of balance and a decrease in scores indicates improvement in balance.
|
two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FRAIL frailty scale
Time Frame: two weeks
|
In the FRAIL frailty scale; patients' weight loss, fatigue, slowness, decreased physical activity and weakness are examined.
Those with 0 points from this questionnaire are classified as fit, those with 1-2 points are classified as pre-frail, and those with 3 or more points are classified as frail.
|
two weeks
|
|
Short Physical Performance Battery
Time Frame: two weeks
|
And The Short Physical Performance Battery consists of 3 objective tests assessing lower body function.
All three physical performance measures (walking speed, balance, getting up from a chair) are scored between 0-4 according to the duration of the activity, and the scores of the three tests are summed to obtain a total score between 0 ( bad) and 12 (very good).
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two weeks
|
|
The stroop test
Time Frame: two weeks
|
The Stroop test .
On each card, there are 6 lines consisting of 4 items.
These stimulus cards constitute the parts of the test and the tasks that the participant has to fulfil against these stimulus cards constitute the parts of the test.
|
two weeks
|
|
the tracking test
Time Frame: two weeks
|
There are two parts in the test, A and B. The completion time of the sequential patterns in the sections is analysed.
Eight sub-scores are calculated by looking at the time, number of errors and corrections.
|
two weeks
|
|
Modified Transplantation Symptom Occurrence and Discomfort - 58-Item Scale
Time Frame: two weeks
|
Each item of the scale assesses a side effect of immunosuppressive drugs.
The form assesses the frequency or intensity of symptom occurrence and the discomfort caused by the symptom in the presence of the symptom.
People will be asked to tick '0' if they have not experienced any symptoms in the last 4 weeks, '1' if they have rarely, '2' if they have sometimes, '3' if they usually, or '4' if they have experienced a lot of symptoms.
Afterwards, according to the distress caused by the symptom, the respondent will be asked to mark the situation he/she experienced from 0 (no distress at all) to 4 (extreme distress).
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two weeks
|
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short form-36 quality of life scale
Time Frame: two weeks
|
It was evaluated with Short form-36 quality of life scale.
It evaluates quality of life especially in individuals with physical illness and provides measurement of quality of life in 8 dimensions: physical function (10 items), social function (2 items), role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items), mental health (5 items), vitality (4 items), pain (2 items) and general perception of health (5 items).
A total score is given separately for each subscale and scores range from 0-100.
A score of '100' indicates good health status, while a score of '0' indicates poor health status.
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two weeks
|
|
Beck depression scale
Time Frame: two weeks
|
Depression assessment with Beck depression scale.
The scale consists of 21 items.
Each item is scored between 0-3.
A higher total score indicates a higher severity or level of depression.
|
two weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: bilge summakoğlu, Dokuz Eylul University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DEU-SBF-BS-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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