ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02567591
Recruitment Status : Recruiting
First Posted : October 5, 2015
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Brief 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.


Condition or disease Intervention/treatment Phase
Motor Activity Other: Physical activity Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Adapted Physical Activity Effect on Aerobic Function and in Patients in Pre Liver Transplantation
Study Start Date : July 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567591


Contacts
Contact: Marilyne DEBETTE-GRATIEN +33(0)5 55 05 66 84 gratien.marie@orange.fr

Locations
France
Limoges Hospital Recruiting
Limoges, France, 87 042
Contact: maryline DEBETTE GRATIEN, MD    +33 5 55 05 66 54    gratien.marie@orange.fr   
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Marilyne DEBETTE-GRATIEN University Hospital, Limoges

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02567591     History of Changes
Other Study ID Numbers: I15017 FAPA
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: June 2016

Keywords provided by University Hospital, Limoges:
pre liver transplantation patients