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

NCT ID: NCT02567591

Last Updated: 2019-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2021-03-31

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.

Conditions

Motor Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

A: physical activity program

at home physical activity program (during 12 weeks)

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: OTHER

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).

B: conventional management

conventional management

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marilyne DEBETTE-GRATIEN

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

Limoges Hospital

Limoges, , France

Site Status: RECRUITING

Tours hospital

Tours, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marilyne DEBETTE-GRATIEN

Role: CONTACT

gratien.marie@orange.fr

+33(0)5 55 05 66 84

Facility Contacts

maryline DEBETTE GRATIEN, MD

Role: primary

gratien.marie@orange.fr

+33 5 55 05 66 54

Ephrem SALAME, MD

Role: primary

esalame@chu-tours.fr

+33 2 47 47 91 61

Other Identifiers

I15017 FAPA

Identifier Type: -

Identifier Source: org_study_id