Motor ActivityFAPANCT02567591
Adapted Physical Activity Effect on Aerobic Function and in Patients in Pre Liver Transplantation
A study testing Physical activity in people with Motor Activity, run by University Hospital, Limoges at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Motor Activity
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2016to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between 18 and 70 years of age,
- Signed informed consent,
- Medical indication to LT whatever the cause of the liver disease
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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
- Being tested
- Physical activity
- Keywords
- pre liver transplantation patients
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
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).
| Study group | Role | What they receive |
|---|---|---|
| A: physical activity program | Experimental | at home physical activity program (during 12 weeks) Receives: Other: Physical activity |
| B: conventional management | No intervention | conventional management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 12 weeks
Secondary outcomes (2)
6 minutes walk test at week 12
To evaluate at Week 12: 6 minutes walk test
Measured: at 12 weeks
After liver transplantation: aerobic capacity (VO2 max)
To evaluate after liver transplantation: aerobic capacity (VO2 max) 3 and 6 months after LT
Measured: 3 and 6 months after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startJul 2016
- Primary completionNov 2020
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marilyne DEBETTE-GRATIEN, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567591
- Sponsor's protocol ID
- I15017 FAPA
- Acronym
- FAPA
- Status last verified
- Sep 2018
- First submitted
- 29 Sep 2015
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted Physical Activity Effect on Aerobic Function and in Patients in Pre Liver Transplantation
- ClinicalTrials.gov ID
- NCT02567591
- Acronym / sponsor ID
- FAPA / I15017 FAPA
- Conditions
- Motor Activity
- Keywords
- pre liver transplantation patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Nov 2020 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: physical activity program | Experimental | Other: Physical activityat home physical activity program (during 12 weeks) |
| B: conventional management | No intervention | –conventional management |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females between 18 and 70 years of age,
- Signed informed consent,
- Medical indication to LT whatever the cause of the liver disease
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activitywalk (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). | Other | A: physical activity program |
Primary outcome
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.
2 secondary outcomes
6 minutes walk test at week 12
Time frame: at 12 weeks
After liver transplantation: aerobic capacity (VO2 max)
Time frame: 3 and 6 months after liver transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
Related trials for Motor Activity
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
Not yet recruiting
Examining the Health Impact of and Promoting Sitting Light Volleyball in the Greater Bay Area
Physial Disabilities
Not yet recruiting
Surface Electromyographic Analysis of Scapular Stabilizer Muscle in Postural Hyperkyphosis
Hyperkyphosis
Not yet recruiting
Evaluation of the Axomove Therapy Medical Device to Facilitate Adapted Physical Activity for Patients With Obesity
Obese Adults
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilyne DEBETTE-GRATIEN principal investigator
University Hospital, Limoges
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Motor Activity, run by University Hospital, Limoges at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 max at 12 weeks (time frame: at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.