Exercise Intervention in Liver Transplant Candidates

Liver Diseases Clinical Trial

Official title:

The Effect of a Personalised Training Programme on the Functional Ability and the Quality of Life of Candidates for Liver Transplantation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04924595
• Other study ID #: AUTh65/2021
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 25, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2021
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Behavioral:
• Personalised exercise
Personalised exercise intervention including aerobic and resistance training

Locations

Country	Name	City	State
Greece	Laboratory of Sports Medicine	Thérmi	Thessaloniki
Greece	Surgical Department of Transplantation A.U.Th.	Thessaloníki	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	VO2max	Maximum oxygen consumption during incremental exercise	Before intervention initiation and after 12-week exercise intervention