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

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.

Study Overview

• Status: Unknown
• Conditions: Motor Activity
• Intervention / Treatment: Other: Physical activity

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marilyne DEBETTE-GRATIEN; Phone Number: +33(0)5 55 05 66 84; Email: gratien.marie@orange.fr

Study Locations

• France
  • Limoges, France, 87 042
    • Recruiting
    • Limoges hospital
    • Contact: maryline DEBETTE GRATIEN, MD; Phone Number: +33 5 55 05 66 54; Email: gratien.marie@orange.fr
  • Tours, France
    • Recruiting
    • Tours hospital
    • Contact: Ephrem SALAME, MD; Phone Number: +33 2 47 47 91 61; Email: esalame@chu-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A: physical activity program; at home physical activity program (during 12 weeks)	Other: Physical 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).
No Intervention: B: conventional management; conventional management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minutes walk test at week 12	To evaluate at Week 12: 6 minutes walk test	at 12 weeks
After liver transplantation: aerobic capacity (VO2 max)	To evaluate after liver transplantation: aerobic capacity (VO2 max) 3 and 6 months after LT	3 and 6 months after liver transplantation

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: Marilyne DEBETTE-GRATIEN, University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: October 2, 2015
• First Posted (Estimate): October 5, 2015

Study Record Updates

• Last Update Posted (Actual): January 7, 2019
• Last Update Submitted That Met QC Criteria: January 4, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: pre liver transplantation patients
• Other Study ID Numbers: I15017 FAPA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No