To assess the additional value of a five day comprehensive assessment and intervention program on exercise and lifestyle followed by a six months maintenance program in primary care compared to the usual care program after solid organ…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
patienten na een orgaantransplantatie ( long, nier, lever, hart)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endurance time as measured bij a Constant Workrate Test. This is a measure of
exercise capacity. The test is done on a stationary bike at 70% op peak
workrate.
Secondary outcome
• Physical Activity (ActivePAL movement monitor, Short questionnaire to assess
health-enhancing physical activity (SQUASH))
• Physical Fitness (Six minute walking test, cardio pulmonary exercise test
(maximal oxygen consumption capacity, maximal load cycled, anaerobic
threshold), peripheral muscle strength tests (biceps, quadriceps, grip)
• Metabolic syndrome and new onset diabetes after transplantation
(Bioelectrical impedance analysis, body mass index, Cholesterol, HbA1C, blood
pressure measurement)
• Psychological status (State-Trait Anxiety Inventory-6 (STAI-6, anxiety),
Patient Health Questionnaire 9 (PHQ9, depression), Exercise self-efficacy
(LIVAS-scale/exercise self-efficacy scale), Six-Dimensional EuroQol instrument
(EQ6D, quality of life), Visual Analogue Scale (VAS, quality of life))
Background summary
The majority of patients after solid organ transplantation does not meet the
recommended amount and type of physical activity. A more sedentary and inactive
lifestyle is reported when compared to the general population. Transplant
recipients have a maximal rate of oxygen consumption (VO2peak) below the normal
range and this reduction in VO2peak is present despite the restoration of near
normal organ function after transplantation. Beside a reduced exercise capacity
around 30-50% of patients develop comorbid conditions such as osteoporosis,
hyperlipidemia and diabetes in the years after transplantation.
We hypothesize that rehabilitation after transplantation will improve the
amount and type of physical activity and reduce comorbidity in patients after
transplantation.
Study objective
To assess the additional value of a five day comprehensive assessment and
intervention program on exercise and lifestyle followed by a six months
maintenance program in primary care compared to the usual care program after
solid organ transplantation on exercise capacity, physical activity, physical
fitness, health related quality of life, anxiety and mood and metabolic
parameters.
Study design
The study design is an open label randomized controlled trial.
Intervention
Before a five day comprehensive assessment and intervention program on exercise
and lifestyle all patients have to fill in some questionaires about health
related quality of live and wear a body monitoring system.
The five day intervention program consists of intakes of a dietician,
psychologist, physiotherapist and physician assistant, testing (2 walking
tests, 1 maximal and 1 endurance cycling tests, Peripheral Muscle Strength Test
of legs, arms and handgrip), training (endurance training and muscle strengt
training in the fitness, swimming), exercise (in the sportcomplex and outside),
education by the nurse, dietician, psychologist and physiotherapist.
All patients will receive a personnal trainingschedule for training six months
in primary care or at home. They will all receive a training diary in which
they will log all there training activities and the experienced intensity.
Patients in the control group visit the University Medical Centre Groningen,
Centre of Rehabilitation, location Beatrixoord for one day. They undergo the
before mentioned tests. Before this day, they wil fill in some questionaires
and wear a movemonitor for one week.
Six months after T0 all physical tests and questionnaires will be repeated in
both the control and rehabilitation group. A body monitoring system will be
worn for one week to obtain information on physical activity. This is for both
groups the same.
Intervention will take place on top of usual medical care.
Study burden and risks
Participation in this study means for the patients in the intervention group
two visits to the University Medical Centre Groningen, Centre of
Rehabilitation, location Beatrixoord, one visit of one day, one visit of five
days.
Patients in de control group will visit the University Medical Centre
Groningen, Centre of Rehabilitation, location Beatrixoord two times a day.
The main risk for patients in this study is to get an injury as a result of
taking blood form the vein. This risk is small however. We expect the benefits
of training will be of more value, than the risk of an injury.
Deelname aan de studie betekent dat patiënten in de interventiegroep 2 keer het
UMCG CVR locatie Beatrixoord moeten bezoeken: een bezoek van een dag en een
bezoek van vijf dagen met eerder beschreven programma.
Patiënten in de controlegroep komen 2x een dag naar het UMCG CVR locatie
Beatrixoord
Dilgtweg 5
Haren 9751ND
NL
Dilgtweg 5
Haren 9751ND
NL
Listed location countries
Age
Inclusion criteria
• Age > 18 years old
• Lung, liver, kidney or heart transplantation
• About 6 months after discharge after transplantation
Exclusion criteria
• Dependence in terms of activity of daily life
• Failure of the transplanted organ < 4 weeks before start of the study
• Impossibility to attend group sessions, such as deafness
• Co-morbidity that interferes with the program
• Unstable cardiac co-morbidities (coronary disease/heart failure)
• Debilitating joint or limb problems/complaints of the musculoskeletal system
interfering with the program
• Drug abuse
• Alcohol abuse
• Analphabetism
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 | NL67525.042.18 |