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CompletedNCT02567591FAPAUpdated Jun 24, 2026

Adapted Physical Activity Effect on Aerobic Function and in Patients in Pre Liver Transplantation

An interventional study of Physical activity in Motor Activity, sponsored by University Hospital, Limoges. Completed at 2 sites in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by University Hospital, Limoges · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Physical exercise has been identified as a major beneficial factor in the management of patients suffering from many chronic diseases especially cancer and in the context of cardiac or pulmonary transplantation. It contributes to an improvement of the quality of life and decreases treatment side effects and mortality. Aerobic fitness is constantly altered in cirrhotic patients and correlated to the severity of the hepatic disease. Moreover, in this setting, other etiological factors may be added like chronic obstructive bronchitis and alcoholic cardiomyopathy. In this population, muscle abnormalities with fatigue and cramps have been described. Muscle weakness in this condition may be comparable to that described in patients with chronic obstructive bronchitis and contributes to the decrease of aerobic fitness. Different causes such as muscle deconditioning, hypoxemia, denutrition, anti-rejection drugs increase this phenomenon after liver transplantation. Finally, the aerobic capacity or VO2max is a prognostic factor for survival and is linked to the number and the length of hospitalizations after liver transplantation (LT).

Therefore, physical activity is a valid and relevant way to improve quality of life, increase survival, and limit costs of hospitalizations. The aim of this study is to assess the effects of a personalized physical activity retraining program on aerobic capacity, strength and fatigue, in a population awaiting liver transplantation.

Purpose: The hypothesis is that an at home adapted retraining program conducted before LT, and including physical activity (aerobic and strength training), will improve aerobic fitness, peripheral strength, quality of life and decrease the hospitalization length in intensive care unit after LT.

02

Conditions studied

  • Motor Activity

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Keywords

  • pre liver transplantation patients
03

In context

Motor Activity

2,426 studies on the registry are indexed under Motor Activity; 1,161 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 2,118 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

University Hospital, Limoges is the lead sponsor of 255 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Males and females between 18 and 70 years of age,
  • Signed informed consent,
  • Medical indication to LT whatever the cause of the liver disease

Exclusion criteria

Exclusion Criteria:

  • Inability to understand the instructions of the trial,
  • Patients who are subject to a court protection, wardship or guardianship order,
  • Uncontrolled cardiac disease and ventricular ejection fraction (vef) \< 50 %,
  • Any other serious conditions which are not stabilized and in which physical exercise is contra-indicated,
  • Pregnancy or suckling,
  • Patients transplanted in extreme emergency.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    A: physical activity program

    at home physical activity program (during 12 weeks)

    Other: Physical activity

  • No intervention
    B: conventional management

    conventional management

Interventions

  • OtherPhysical activity

    walk (three times per week) and muscle building twice per week with the use of elastic bands. They will include 5 strengthening exercises mobilizing large muscle groups of the lower limbs (abs (if possible for the patient), hamstrings, quadriceps, triceps sural and gluteus maximus).

06

What researchers measure

Primary outcomes

  1. VO2 max at 12 weeks

    To evaluate the impact of a personalized physical activity program after 12 weeks of exercise on the aerobic capacity measured by VO2 max, in patients awaiting liver transplantation.

    Time frame: at 12 weeks

Secondary outcomes

  1. 6 minutes walk test at week 12

    To evaluate at Week 12: 6 minutes walk test

    Time frame: at 12 weeks

  2. After liver transplantation: aerobic capacity (VO2 max)

    To evaluate after liver transplantation: aerobic capacity (VO2 max) 3 and 6 months after LT

    Time frame: 3 and 6 months after liver transplantation

07

Study locations

2 sites
  • Limoges Hospital
    Limoges, 87 042, France
  • Tours hospital
    Tours, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02567591
Lead sponsor
University Hospital, Limoges
Responsible party
Sponsor
First posted
Oct 5, 2015
Start date
Jul 2016
Primary completion
Nov 2020
Completion
Mar 2021
Last update
Jun 24, 2026

Study contacts

Marilyne DEBETTE-GRATIEN
principal investigator · University Hospital, Limoges

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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