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NCT Number: NCT02567591

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Limoges Hospital, Limoges, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Physical activity

Other

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).

Primary outcomes

  1. VO2 max at 12 weeks

    Time frame: 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.

Secondary outcomes

  1. 6 minutes walk test at week 12

    Time frame: at 12 weeks

    To evaluate at Week 12: 6 minutes walk test

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

    Time frame: 3 and 6 months after liver transplantation

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

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: FAPA

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Oct 5, 2015
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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