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Exercise Intervention in Liver Transplant Candidates

Primary Purpose

Liver Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Personalised exercise
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Surgical Department of Transplantation A.U.Th.
  • Laboratory of Sports Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Regular treatment

Exercise Intervention

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline "Liver Frailty Index" value at 12 weeks
A frailty index for patients with cirrhosis, comprised of three performance-based metrics
Change from Baseline "6 Minute Walking Test" value at 12 weeks
A walking test for patients to evaluate their functional capacity

Secondary Outcome Measures

VO2max
Maximum oxygen consumption during incremental exercise

Full Information

First Posted
May 30, 2021
Last Updated
June 7, 2021
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT04924595
Brief Title
Exercise Intervention in Liver Transplant Candidates
Official Title
The Effect of a Personalised Training Programme on the Functional Ability and the Quality of Life of Candidates for Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 25, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regular treatment
Arm Type
No Intervention
Arm Title
Exercise Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Personalised exercise
Intervention Description
Personalised exercise intervention including aerobic and resistance training
Primary Outcome Measure Information:
Title
Change from Baseline "Liver Frailty Index" value at 12 weeks
Description
A frailty index for patients with cirrhosis, comprised of three performance-based metrics
Time Frame
After 12-week exercise intervention
Title
Change from Baseline "6 Minute Walking Test" value at 12 weeks
Description
A walking test for patients to evaluate their functional capacity
Time Frame
After 12-week exercise intervention
Secondary Outcome Measure Information:
Title
VO2max
Description
Maximum oxygen consumption during incremental exercise
Time Frame
Before intervention initiation and after 12-week exercise intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilias M Oikonomou, MD
Organizational Affiliation
Aristotle University Of Thessaloniki
Official's Role
Principal Investigator
Facility Information:
Facility Name
Surgical Department of Transplantation A.U.Th.
City
Thessaloníki
State/Province
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Laboratory of Sports Medicine
City
Thérmi
State/Province
Thessaloniki
ZIP/Postal Code
57001
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Exercise Intervention in Liver Transplant Candidates

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