- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04924595
Exercise Intervention in Liver Transplant Candidates
June 7, 2021 updated by: Ilias Marios Oikonomou, Aristotle University Of Thessaloniki
The Effect of a Personalised Training Programme on the Functional Ability and the Quality of Life of Candidates for Liver Transplantation
The aim of the study is to investigate the effect of personalised exercise interventions in liver transplant candidates, aiming to prevent or limit sarcopenia and frailty, as well as improving their cardiorespiratory health.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Thessaloniki
-
Thessaloníki, Thessaloniki, Greece, 54642
- Surgical Department of Transplantation A.U.Th.
-
Thérmi, Thessaloniki, Greece, 57001
- Laboratory of Sports Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Liver transplant candidates, accepted in the waiting list of the Surgical Department of Transplantation A.U.Th., General Hospital of Thessaloniki "Ippokratio".
Exclusion Criteria:
- Recent (<12 months) Acute Myocardial Infraction
- Recent (<12 months) brain strokes
- Uncontrolled and/or untreated arrythmia
- Hepatic encephalopathy
- Bed-bound patient
- Liver Transplantation
- Death
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Regular treatment
|
|
Experimental: Exercise Intervention
|
Personalised exercise intervention including aerobic and resistance training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline "Liver Frailty Index" value at 12 weeks
Time Frame: After 12-week exercise intervention
|
A frailty index for patients with cirrhosis, comprised of three performance-based metrics
|
After 12-week exercise intervention
|
Change from Baseline "6 Minute Walking Test" value at 12 weeks
Time Frame: After 12-week exercise intervention
|
A walking test for patients to evaluate their functional capacity
|
After 12-week exercise intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VO2max
Time Frame: Before intervention initiation and after 12-week exercise intervention
|
Maximum oxygen consumption during incremental exercise
|
Before intervention initiation and after 12-week exercise intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ilias M Oikonomou, MD, Aristotle University Of Thessaloniki
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 25, 2021
Primary Completion (Anticipated)
August 31, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
May 30, 2021
First Submitted That Met QC Criteria
June 7, 2021
First Posted (Actual)
June 14, 2021
Study Record Updates
Last Update Posted (Actual)
June 14, 2021
Last Update Submitted That Met QC Criteria
June 7, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AUTh65/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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