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

NCT02567591 | Unknown

• 1 other identifier: I15017 FAPA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Keywords

pre liver transplantation patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 6 minutes walk test at week 12

  at 12 weeks

• After liver transplantation: aerobic capacity (VO2 max)

  3 and 6 months after liver transplantation

Study Arms (2)

A: physical activity program

EXPERIMENTAL

at home physical activity program (during 12 weeks)

Other: Physical activity

B: conventional management

NO INTERVENTION

conventional management

Interventions

Physical activity 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).

A: physical activity program

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between 18 and 70 years of age,
• Signed informed consent,
• Medical indication to LT whatever the cause of the liver disease

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (2)

Limoges Hospital

Limoges, 87 042, France

RECRUITING

Tours hospital

Tours, France

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marilyne DEBETTE-GRATIEN

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marilyne DEBETTE-GRATIEN

CONTACT

+33(0)5 55 05 66 84; gratien.marie@orange.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 5, 2015
• Study Start: July 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: March 1, 2021
• Last Updated: January 7, 2019

Record last verified: 2018-09

Locations

FR (2)