Enhancing the medium and long-term benefits of a structured rehabilitation (Beweegkuur+) program in long-standing type 2 diabetes patients with multiple disabling co-morbidities.

Physical exercise training is an important tool for improving blood glucose
homeostasis in type 2 diabetic patients. A combined resistance and endurance
type exercise training program can be applied effectively to improve functional
capacity, body composition and metabolic control in type 2 diabetes patients.
However, in obese long-standing type 2 diabetes patients with multiple
co-morbidities, the impact of structured exercise on health has not been
assessed. Because of the high cardiovascular risk profile and functional
disabilities in these patients, therapeutic exercise programs have hardly been
evaluated in this type 2 diabetes subpopulation.

The current research proposal aims to investigate the medium and long-term
health benefits of a combined supervised exercise and dietary intervention
versus a dietary intervention (=usual care) in obese long-standing type 2
diabetes patients. It is hypothesized that supervised exercise training
combined with dietary measures will improve muscle strength cardiorespiratory
fitness and body composition. The latter will improve both physical and mental
health status, resulting in improved metabolic control through a durable
increase in total weekly energy expenditure.

a multi-center clinical trial

In addition to the protocolised diabetes care, 60 type 2 diabetes patients for
the exercise and dietary intervention will be invited for an intake with a
sport and exercise/rehabilitation physician and a physical therapist.
Subsequently they will be asked to adhere to 26 weeks of once a week
progressive resistant type of exercise, supplemented by short bouts of high
intensity interval endurance training. There are 3 possible test and training
locations:
1) location Erasmus MC, department of Rehabilitation Medicine and Physical
Therapy,
2) Medical Center Haaglanden, location Antoniushove, department of Sports
Medicine
3) Zorgsaam Zeeuws-Vlaanderen, location de Honte, department of Physical Therapy
At all 3 locations a physician will be available within 5 minutes in case of
complications.
At the end of each exercise session participants will be asked and motivated to
walk or cycle at least 30 min a day on the remaining days of the week.On top of
the supervised exercise sessions and ususal care the intervention group will
consult a dietician on a montly basis during the first 6 months to guide and
support patients in following an energy restricted diet (-600 kcal/day) aimed
at a weight reduction of 5-10% over 6 months.
In addition to the protocolised diabetes care, 30 type 2 diabetes patients not
participating for the exercise and dietary intervention will be invited for an
intake with a sport and exercise/rehabilitation physician and a physical
therapist. Subsequently they will be asked to complete the questionnaires and
will be interviewed preferably during an appointment in one of the
participating hospitals and when this is not possible by telephone.

Patients willing and not willing to participate will be asked to fill out a
short questionnaire to assess their motivational status and reasons for (not)
participating.
All diabetes health care workers working in a hospital setting, that showed
interest or agreed to recruit patients for this study, will be asked to fill in
a validated questionnaire that assesses barriers and facilitators for
implementation.

As an extension of the original research proposal, all diabetes health care
workers working in a hospital setting, that showed interest or agreed to
recruit patients for this study, will be asked to fill in a validated
questionnaire that assesses barriers and facilitators for implementation. The
latter questionnaire has been developed by the Centre for Quality of Care
Research (WOK) (61) and assessing the perceived barriers and difficulties for
the Beweegkuur+ life-style intervention from the perspective of the health care
provider. Furthermore, patients that have been approached by their health care
provider, but have decided not to participate will be asked to fill out a
questionnaire on the perceived barriers to participate in this trial. The
latter information will be essential for a successful implemention of
well-structured exercise and dietary interventions in a hospital setting in the
near future

Testing procedures before and 26 and 52 weeks following the start of the
exercise intervention:
Before final inclusion all patients will undergo a symptom limited cycle
ergometry test with 12 lead ECG monitoring. In case silent myocardial ischaemia
is suspected [58], patients will be referred to a cardiologist.

Fasting blood samples will be obtained to measure Hb, Ht, CRP, HbA1c, plasma
glucose, HDL-C, LDL-C, T-Chol, Triglycerides and FFA, during fasting
conditions. Subjects will be asked to fill out a 3-day dietary record both
before as well as 26 and 52 weeks following the start of the training program
to estimate energy consumption and meal composition. The latter information
will be used to provide the patient with a tailor made online advice on a
healthier diet as recommended by the Dutch Diabetes Federation.

Accelerometry based activity monitors (Actigraph) will be worn by the patients
during 7 days to assess daily energy expenditure and both In addition and
personal exercise diaries, will be used to estimate leisure-time physical
activity.

Peak whole-body oxygen uptake capacity (VO2peak) and maximal workload capacity
(Wmax) will be measured during an incremental exhaustive exercise test until
volitional exhaustion, performed on a cycle ergometer using a ramp protocol.
Gas exchange measurements will be performed continuously. During exercise
testing a 12-lead electrocardiogram and blood pressure will be monitored and
recorded.
Because the exercise test will be executed in a hospital setting with ECG
monitoring and direct supervision of a physician, the risk of cardiac
ischemia/arritmia is small. If a hypoglycemic event occurs, there will
carbohydrate solutions or, in case of loss of consciousness, Glucagon
(Glycagen, 1 mg dissolved in 1 ml) are available.

Muscle strength testing will be used to measure muscle strength of the upper
arm and leg muscles. To test improvements in functional capacity a standardized
Sit-to-Stand as well as a steep ramp test on a cycle ergometer will be
performed.

Health related quality of life will be measured using the Short-Form 36
questionnaire health survey.
Levels of depressive symptoms will be measured using the 20-item Centre for
Epidemiologic Studies Depression Scale (CES-D score >= 16). To measure diabetes
symptom distress, we will use the revised version of the Type 2 Diabetes
Symptom Checklist.

Patients willing and not willing to participate will be asked to fill out a
short questionnaire to assess their motivational status and reasons for (not)
participating.