Group rehabilitation for renal patients

Exercise intolerance and skeletal muscle weakness are common in dialysis and
renal transplant patients and severely compromise quality of life. In the
earlier study ''Body composition and muscle dysfunction in renal patients:
underlying mechanisms and the response to exercise training* (performed at the
department of internal medicine at the Maastricht University Medical Center,
funded by the Dutch Kidney Foundation (Projectcode C99.1825), the short-term
effectiveness of an intensive, supervised exercise training program (twice
weekly during a period of 12 weeks; combination of endurance and resistance
training) has been investigated in a natural groups cohort study. Exercise
training seemed to have beneficial effects on exercise capacity, skeletal
muscle strength and quality of life of renal transplant and hemodialysis
patients. Quality of life (in particular scores related to physical
functioning) is a strong predictor of morbidity and mortality in dialysis
patients. In renal transpalnt patients, the beneficial effects of exercise
training may prevent the development of new medical problems such as obesity,
abnormalities in the lipid profile, posttransplant diabetes mellitus, and
cardiovascular disease. The long-term effectiveness and cost-effectiveness of
exercise training programs for renal transplant and dialysis patients have,
however, not yet been established. Therefore, the long-term effectiveness and
cost-effectiveness of an intensive, supervised exercise training program will
be investigated in a randomised controlled design in renal transplant and
dialysis patients. Results of such a study are important to convince health
care insurers that exercise training is (cost)effective and has to be
considered as a structural part of the routine treatment of renal transplant
and dialyis patients and therefore should be routinely reimbursed.

The purpose of GRN-study is: 1. to determine the long-term effectiveness of a
12 weeks lasting physical exercise training program. 2. to determine the
costeffectiveness of the 12 weeks lasting physical exercise training program.
In aim of the GRN-ACT substudy is to study the prevention of posttransplant
adiposity and its adverse cardiometabolic effects by a combined
diet-and-physical activity program or exercise intervention in renal transplant
patients starting in the first year after transplantation.

Randomised controlled trial

Dialysis patients in the study are randomised into two groups: The exercise
intervention group (I): Patients assigned to the intervention group participate
in a 12 weeks lasting, intensive, standardized and supervised physical training
program (twice weekly a session of 2 hours) which consists of a combination of
endurance and strength training. The training sessions will be performed in
mixed groups of renal transplant and dialysis patients (n = 10-12). After
completion of the training program, patients receive an individual sport- and
physical activity advice. Subsequently, patients will receive usual care in the
12 months lasting follow-up period. During the follow-up period patients is
offered the possibility to schedule three consultations with a lifestyle coach
(facultative). The usual care group (II): Patients assigned to the usual care
group receive the standard medical care (usual care) during the 15 months
lasting study period. Physical training does not form a part of the usual care
of renal transplant and dialysis patients. After randomisation, patients
assigned to the usual care group receive the advice to meet the 'Nederlandse
Norm Gezond Bewegen (NNGB), i.e. the advice to perform 30 minutes of moderately
intense physical activity at at least five but preferably all days of the week.
In both groups, measurements performed at baseline (measurement of quality of
life, exercise capacity, muscle strength, physical activity level, subjective
global assessment, bloodpressure, fatigue and labor participation) will be
repeated at t = 12 weeks, t = 6 months and t = 15 months. In group I, maximal
exercise capacity and maximal skeletal muscle strength will be measured at t =
6 weeks too. Besides, patients in both groups will complete (retrospective)
cost-questionnaires at t = 0, 3, 6, 9, 12 and 15 months. After baseline
measurements of quality of life, exercise capacity, muscle strength, physical
activity level, subjective global assessment, bloodpressure, fatigue, labor
participation and health care costs, renal transplant patients in the GRN-ACT
substudy are randomised into three groups: The exercise intervention group (I):
patients assigned to the exercise intervention group will follow the same
exercise intervention program (intervantion and follow-up) as dialysis patients
which will be assigned to the exercise intervention group (see above). The
usual care group (II): Patients assigned to the usual care group receive the
standard medical care (usual care) during the 15 months lasting study period.
Physical training does not form a part of the usual care of renal transplant
and dialysis patients. After randomisation, patients assigned to the usual care
group receive the advice to meet the 'Nederlandse Norm Gezond Bewegen (NNGB),
i.e. the advice to perform 30 minutes of moderately intense physical activity
at at least five but preferably all days of the week. The combined exercise and
diet intervention group (group III): Patients assigned to the combined exercise
and diet intervention group (group III) follow the same program as group I but
extended with a dietary intervention. Patients will be consulted by a dietitian
who will discuss the dietary habits of the patients. During these consultations
personal goals will be set for maintenance of healthy dietary habits. During
the first 12 weeks of the intervention program consultations will take place
every 2 weeks (6x), after this period every 3 months. In all groups of
transplant patients in the GRN-ACT substudie, measurements performed at
baseline (measurement of quality of life, exercise capacity, muscle strength,
physical activity level, subjective global assessment, bloodpressure, fatigue
and labor participation) will be repeated at t = 12 weeks, t = 6 months and t =
15 months. In group I and III, maximal exercise capacity and maximal skeletal
muscle strength will be measured at t = 6 weeks too. Insulin sensitivity will
be performed in all groups (OGTT) at t= 0, 3 and 15 months. Blood measurements
will be performed in all groups at t= 0, 3, 6 and 15 months. Bloo















































d sampling will take place at the same time as a regular care consult, so no
extra blood sampling will be needed. Besides, patients in all groups will
complete (retrospective) cost-questionnaires at t = 0, 3, 6, 9, 12 and 15
months. In group I en group II nutritional habits will be measured at t= 0, 3,
en 15 months. In group III nutritional habits will also be measured at t= 6
months. In group I en group II nutritional knowledge will be measured at t= 0
and 15 months. In group III this will also be measured at t= 6 months. Fear of
movement will be measured at t=0, 3 en 15 months in groups I, II and III.
Copingstyle will be measured in all groups only at t=0.

The follow-up period of the study is 15 months. Patients assigned to the
exercise intervention group (group I) participate in a 12 weeks lasting,
intensive, standardized and supervised physical training program (twice weekly
a session of 2 hours). After completion of the training program, patients
receive an individual sport- and physical activity advice. Subsequently,
patients will receive usual care in the 12 months lasting follow-up period.
During the follow-up period patients is offered the possibility to schedule
three consultations with a lifestyle coach (facultative). Patients assigned to
the usual care group (group II) receive the standard medical care (usual care)
during the 15 months lasting study period. Physical training does not form a
part of the usual care of renal transplant and dialysis patients. After
randomisation, patients assigned to the usual care group receive the advice to
meet the 'Nederlandse Norm Gezond Bewegen (NNGB), i.e. the advice to perform 30
minutes of moderately intense physical activity at at least five but preferably
all days of the week. Patients assigned to the combined exercise and diet
intervention group (group III) follow the same program as group I but extended
with a dietary intervention. Patients will be consulted by a dietitian who will
discuss the dietary habits of the patients. During these consultations personal
goals will be set for maintenance of healthy dietary habits. During the first
12 weeks of the intervention program consultations will take place every 2
weeks (6x), after this period every 3 months. In both groups, measurements
performed at baseline (measurement of quality of life, exercise capacity,
muscle strength, physical activity level, subjective global assessment,
bloodpressure, fatigue and labor participation) will be repeated at t = 12
weeks, t = 6 months and t = 15 months. In group I, maximal exercise capacity
and maximal skeletal muscle strength will be measured at t = 6 weeks too.
Besides, patients in both groups will complete (retrospective)
cost-questionnaires at t = 0, 3, 6, 9, 12 and 15 months. In all groups of
transplant patients in the GRN-ACT substudie, measurements performed at
baseline (measurement of quality of life, exercise capacity, muscle strength,
physical activity level, subjective global assessment, bloodpressure, fatigue
and labor participation) will be repeated at t = 12 weeks, t = 6 months and t =
15 months. In group I and III, maximal exercise capacity and maximal skeletal
muscle strength will be measured at t = 6 weeks too. Insulin sensitivity will
be performed in all groups (OGTT) at t= 0, 3 and 15 months. Blood measurements
will be performed in all groups at t= 0, 3, 6 and 15 months. Blood sampling
will take place at the same time as a regular care consult, so no extra blood
sampling will be needed. Besides, patients in all groups will complete
(retrospective) cost-questionnaires at t = 0, 3, 6, 9, 12 and 15 months. In
group I en group II nutritional habits will be measured at t= 0, 3, en 15
months. In group III nutritional habits will also be measured at t= 6 months.
In group I en group II nutritional knowledge will be measured at t= 0 and 15
months. In group III this will also be measured at t= 6 months. Fear of
movement will be measured at t=0, 3 en 15 months in groups I, II and III.
Copingstyle will be measured in all groups only at t=0. The protocol provides
in strict precautions to warrant patient's safety during exercise tests and
exercise training. Prior to the baseline measurements, the nephrologist
assesses whether or not a patient is able to participate in the study based on
medical-technical grounds (eg based on medical history, auscultation of heart
and lungs, measurement of blood pressure and possibly an ECG). If indicated,
the nephrologist calls the cardiologist in consult to take this decision. For
each patient, an individual (standardized) training program based on the
results of the cycle and strenght tests at baseline will be developed. Exercise
tests, skeletal muscle strenght tests and trainingsessions will be















































performed under (medical) supervision. Furthermore, a solid warming-up will be
performed before each exercise test, skeletal muscle strength test and
trainingsession in order to reduce the risk of exercise-related injuries.
Maximal exercise tests will be performed under medical supervision and ECG and
blood pressure monitoring and will be terminated if changes in ECG occur,
systolic blood pressure exceeds 250 mmHg, diastolic blood pressure is 120 mmHg
or higher, or blood pressure decreases 20 mmHg or more. There are detailed
instructions on how to act when problems occur during the trainingprogram. The
physical training program and exercise tests do not have adverse effects on
renal function. The OGTT for measurement of insuline sensitivity could cause
some nausea. Blood samples will be taken by educated and experienced laboratory
employees.