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

U

University of Limoges (UL)

Status

Unknown

Conditions

Motor Activity

Treatments

Other: Physical activity

Study type

Interventional

Funder types

Other

Identifiers

NCT02567591
I15017 FAPA

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

A: physical activity program
Experimental group
Description:
at home physical activity program (during 12 weeks)
Treatment:
Other: Physical activity
B: conventional management
No Intervention group
Description:
conventional management

Trial contacts and locations

2

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Central trial contact

Marilyne DEBETTE-GRATIEN

Data sourced from clinicaltrials.gov

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