NCT04924595

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 30, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

May 30, 2021

Last Update Submit

June 7, 2021

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • VO2max

    Before intervention initiation and after 12-week exercise intervention

Study Arms (2)

Regular treatment

NO INTERVENTION

Exercise Intervention

EXPERIMENTAL
Behavioral: Personalised exercise

Interventions

Personalised exerciseBEHAVIORAL

Personalised exercise intervention including aerobic and resistance training

Exercise Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Liver transplant candidates, accepted in the waiting list of the Surgical Department of Transplantation A.U.Th., General Hospital of Thessaloniki "Ippokratio".

You may not qualify if:

  • Recent (\<12 months) Acute Myocardial Infraction
  • Recent (\<12 months) brain strokes
  • Uncontrolled and/or untreated arrythmia
  • Hepatic encephalopathy
  • Bed-bound patient
  • Liver Transplantation
  • Death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Laboratory of Sports Medicine

Thermi, Thessaloniki, 57001, Greece

Location

Surgical Department of Transplantation A.U.Th.

Thessaloniki, Thessaloniki, 54642, Greece

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Ilias M Oikonomou, MD

    Aristotle University Of Thessaloniki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Associate for the Surgical Department of Transplantation A.U.Th., Postgraduate Student, Medical Doctor

Study Record Dates

First Submitted

May 30, 2021

First Posted

June 14, 2021

Study Start

April 25, 2021

Primary Completion

August 31, 2021

Study Completion

December 31, 2021

Last Updated

June 14, 2021

Record last verified: 2021-06

Locations

GR(2)