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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02567591
Acronym
FAPA
Enrollment
30
Registered
2015-10-05
Start date
2016-07-01
Completion date
2021-03-01
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motor Activity

Keywords

pre liver transplantation patients

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.

Interventions

OTHERPhysical 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).

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
VO2 max at 12 weeksat 12 weeksTo 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

MeasureTime frameDescription
6 minutes walk test at week 12at 12 weeksTo evaluate at Week 12: 6 minutes walk test
After liver transplantation: aerobic capacity (VO2 max)3 and 6 months after liver transplantationTo evaluate after liver transplantation: aerobic capacity (VO2 max) 3 and 6 months after LT

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMarilyne DEBETTE-GRATIEN

University Hospital, Limoges

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026