Exercise Intervention in Liver Transplant Candidates | NCT04924595

Studies
Exercise Intervention in Liver Transplant Candidates

NCT04924595

Sponsor

Aristotle University Of Thessaloniki

Status

Unknown status

Last Update Posted

Jun 14, 2021Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Liver Diseases

Interventions

Personalised exercise

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 25, 2021Actual

Primary Completion Date

Aug 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

May 30, 2021

First Submission Date that Met QC Criteria

Jun 7, 2021

First Posted Date

Jun 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2021

Last Update Posted Date

Jun 14, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ilias Marios Oikonomou, Scientific Associate for the Surgical Department of Transplantation A.U.Th., Postgraduate Student, Medical Doctor, Aristotle University Of ThessalonikiPrincipal Investigator

Lead Sponsor

Aristotle University Of ThessalonikiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Regular treatment	No Intervention
Exercise Intervention	Experimental		Behavioral: Personalised exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Personalised exercise	Behavioral	Personalised exercise intervention including aerobic and resistance training	Exercise Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline "Liver Frailty Index" value at 12 weeks	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	A walking test for patients to evaluate their functional capacity	After 12-week exercise intervention

Secondary Outcomes

Measure	Description	Time Frame
VO2max	Maximum oxygen consumption during incremental exercise	Before intervention initiation and after 12-week exercise intervention

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ilias M Oikonomou, MD	Aristotle University Of Thessaloniki	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratory of Sports Medicine		Thermi	Thessaloniki	57001	Greece
Surgical Department of Transplantation A.U.Th.

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008107	Liver Diseases

Ancestor Terms

ID	Term
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided