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

Motor Activity Clinical Trial

— FAPA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02567591
• Other study ID #: I15017 FAPA
• Status: Recruiting
• Phase: N/A
• Start date: July 2016
• Est. completion date: March 2021

Study information

• Verified date: September 2018
• Source: University Hospital, Limoges
• Contact: Marilyne DEBETTE-GRATIEN
• Phone: +33(0)5 55 05 66 84
• Email: gratien.marie[@]orange.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2021
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Motor Activity

Intervention

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).

Locations

Country	Name	City	State
France	Limoges Hospital	Limoges
France	Tours hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 minutes walk test at week 12	To evaluate at Week 12: 6 minutes walk test	at 12 weeks
Secondary	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