Adapted Physical Activity Effect on Aerobic Function and in Patients in Pre Liver Transplantation (FAPA)
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|ClinicalTrials.gov Identifier: NCT02567591|
Recruitment Status : Recruiting
First Posted : October 5, 2015
Last Update Posted : August 15, 2016
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|
|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|
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
- 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.
- 6 minutes walk test at week 12 [ Time Frame: at 12 weeks ]To evaluate at Week 12: 6 minutes walk test
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567591
|Contact: Marilyne DEBETTE-GRATIEN||+33(0)5 55 05 66 firstname.lastname@example.org|
|Limoges, France, 87 042|
|Contact: maryline DEBETTE GRATIEN, MD +33 5 55 05 66 54 email@example.com|
|Principal Investigator:||Marilyne DEBETTE-GRATIEN||University Hospital, Limoges|