Aim of the preceding study is to explore the applicability and feasibility of a rehabilitation program for improvement of complaints of fatigue in liver transplant recipients.
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Severity of fatigue (patients)
(see also page 10)
Secondary outcome
2. Everyday physical activity (patients and healthy persons)
3. Cardiorespiratory fitness (patients and healthy persons)
4. Neuromuscular fitness (patients and healthy persons)
5. Health-related quality of life (patients)
6. Health-related functional status (patients)
7. Sleep quality (patients)
8. Anxiety en depression (patients)
9. Participation (epatients)
10. Self-efficacy (patients)
11. Coping (patients)
12. Satisfaction patient (patients)
13. Feasibility rehabilitation program
14. Costs rehabilitation program
(see also pages 10 to 13)
Background summary
Liver transplant recipients often experience severe complaints of fatigue and
these complaints seem not to decrease over time. The cause of this fatigue is
often not clear. However, there are indications that fatigue after liver
transplantation is accompanied by a low level of daily physical activity and a
low physical fitness.
Study objective
Aim of the preceding study is to explore the applicability and feasibility of a
rehabilitation program for improvement of complaints of fatigue in liver
transplant recipients.
Study design
The study concerns a longitudinal effect-study (pilot). We will explore whether
liver transplant recipients who participated in the rehabilitation program have
improved with respect to fatigue, level of everyday physical activity, physical
fitness (cardiorespiratory, neuromuscular, body composition), health-related
quality of life and a number of other factors. We will also explore to what
extent there are relations between (changes in) severity of fatigue complaints
on the one hand and (changes in) the level of everyday physical activity,
physical fitness (cardiorespiratory, neuromuscular, body composition),
health-related quality of life, and a number of other factors on the other
hand. The rehabilitation program will be offered during three months and
consists of 'physical fitness' module and 'active lifestyle' module. Fatigue
questionnaires; Activity Monitor measurements; a progressive maximal aerobic
test on a cycle ergometer; a 6-minute walk test; muscle strength measurements;
body composition measurements; and a questionnaire concerning quality of life
will be used to evaluate the applicability of the program. Furthermore, the
feasibility of the rehabilitation program will be evaluated. This will be done
using a semi-structered interview, in which the participants are asked to
assess the content and organisation of the rehabilitation program.
Intervention
The rehabilitation program will be offered during three months and consists of
a 'physical fitness' module (2 times a week 1 hour cardiorespiratory and
neuromuscular exercise) and a 'active lifestyle' module (i.e. the subject will
be stimulated to improve his/her everyday physical activity by means of
counseling (4 sessions)).
Study burden and risks
Patients:
The pre and post-treatment measurements consist of the collection of
demographic data and medication use, functional measurements in the movement
laboratory and some questionnaires. This will last approximately 5 hours,
including rest periods. The instrumentation of the Activity Monitor and some
questionnaires will last 2 hours; the time to remove the Activity Monitor will
take 30 minutes. 3 months after the rehabilitation program the patients will be
asked to fill in only the fatigue questionnaire (15 minutes) (follow-up).
The patients follow the parts 'physical fitness' and 'active lifestyle'
during a period of 3 months. Duration of the part 'physical fitness': 2 hours a
week, during 3 months. Duration of the part 'active lifestyle': 4 individual
conversations of 1 hour each.
For the progressive maximal cycle ergometer test and the strength test
subjects have to exert themselves maximally. Before the tests, there will be
checked if it is safe to carry them out. During testing there will always be a
doctor present. The other tests are not dangerous and are not a risk for the
participants.
Healthy persons:
Collection of demographic data and functional measurements in the movement
laboratory. This will last approximately 4 hours, including rest periods. The
instrumentation of the Activity Monitor will last 1 hour; the time to remove
the Activity Monitor will take 30 minutes.
For the progressive maximal cycle ergometer test and the strength test
subjects have to exert themselves maximally. Before the tests, there will be
checked if it is safe to carry them out. During testing there will always be a
doctor present. The other tests are not dangerous and are not a risk for the
participants.
Dr Molewaterplein 40
3015 GD Rotterdam
Nederland
Dr Molewaterplein 40
3015 GD Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Inclusion criteria patients:
- Sufficient knowledge of the Dutch language.
- Liver transplantation at least one year ago in the Erasmus MC.
- Age between 18 and 65 years.
- Persons must have complaints of fatigue: Fatigue Severity Scale (FSS) score> 4.
See also protocol page 10 and appendix 5.;Inclusion criteria healthy persons:
- Sufficient knowledge of the Dutch language.
- Age between 18 and 65 years.
Exclusion criteria
Exclusion criteria patients:
- Multiorgan transplant recipients.
- Severe comorbidity.
- Contra-indication for a progressive maximal cycle ergometer test.
- Contra-indication for exercise.;Exclusion criteria healthy persons:
- Disorders that may interfere with the measurements.
- Contra-indication for a progressive maximal cycle ergometer test.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL11808.078.06 |