Beweegkuur +.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR2464
• Date of registration: 11/08/2010
• Primary sponsor: Erasmus Medical Center
• Public title: Beweegkuur +.
• Scientific title: The medium and long-term benefits of a structured rehabilitation (Beweegkuur+) program in long-standing type 2 diabetes patients with multiple disabling co-morbidities. -
• Date of first enrolment: 10/8/2010
• Target sample size: 80
• Recruitment status: recruiting
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2464
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: S.F.E. Praet

• Name: D. Visser

Key inclusion & exclusion criteria

Inclusion criteria: 1. Type 2 diabetes > 5 years;

2. Signs of 3 or more diabetes¨Crelated co-morbidities (history of sensori-motor or autonomic neuropathy,retinopathy (gr II or higher), micro-albuminuria, coronary artery disease, transient ischaemic attack, intermittent claudication/peripheral artery disease);

3. HbA1c: 7.0- 10.0%;

4. Age: 45-75 yrs;

5. BMI > 27kg/m2;

6. Sedentary behaviour (i.e. <30 min/day moderately active assessed by activity monitoring);

7. Agreement to volunteer for the study by giving a written informed consent.
Exclusion criteria: 1. Cardio-vascular disease, recent (< 3 m) decompensatio cordis, recent (3 m) unstabile angina pectoris, recent
(< 3 m) myocardial infarction, significant cardiac ischaemia during SPECT myocardial perfusion imaging, heartfailure (EF<40% or NYHA class 3 or 4);

2. Severe orthopaedic impairments that would prohibit participation in the training program (eg diabetes ulcers of the foot, amputations);

3. Cerebro-vascular disease (CVA) or other neurological diseases or deficits that would prohibit participation in
the training program (eg spasticity).

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Diabetes Mellitus type 2 (DM type II)

Intervention(s)

In case of an abnormal stress-ECG during a symptom-limited exercise test, more extensive cardiovascular screening (stress single-photon emission computed tomography (SPECT) myocardial perfusion imaging) left ventricular diastolic function using echocardiography will take place by a cardiologist. Patients will be randomized to follow either a 26 weeks combined supervised exercise and dietary intervention program or to take part in a dietary intervention program aimed at decreasing daily energy intake with 600 kcal/day. Before and after 26 and 52 weeks, blood samples (HbA1c, plasma glucose, plasma insulin, HDL-C, LDL-C, TChol, Triglycerides and FFA, both during fasting conditions) and questionnaires will be collected to assess changes in glycemic control, lipid profile, health-related quality of life (Short-Form 36 questionnaire health survey), diabetes burden (revised version of the Type 2 Diabetes Symptom Checklist) and depression scores (20-item Centre for Epidemiologic Studies Depression Scale), respectively. Accelerometry based activity monitors (Actigraph) and personal exercise diaries, will be used to assess changes in daily physical activity levels. Changes in regional body composition, functional capacity, muscle strength and cardiorespiratory fitness will be assessed using respectively DEXA-scan and skinfold measurements, functional tests (Sit-to-Stand, 6 minute walking test), isokinetic testing and cycle-ergometry protocol.

Primary Outcome(s)

The primary outcome measure evaluates the clinical efficacy of the intervention on the standard diabetes outcome
parameter for glycemic control (HbA1c).

Secondary Outcome(s)

The secondary diabetes related outcome measures evaluate the overall effect on health:

1. Risk profile for cardiovascular disease (lipid profile, arterial blood pressure, heart rate variability);

2. Body composition (BMI, waist circumference, regional fat distribution);

3. Cardiorespiratory fitness (VO2peak);

4. Left ventrical diastolic function (echocardiography);

5. Functional capacity and muscle strength;

6. Health-related quality of life (SF-36);

7. Level of depressive symptoms using the Centre for Epidemiologic Studies Depression Scale (CES-D);

8. Diabetes symptom distress (using the revised version of the Type 2 Diabetes Symptom Checklist).

Secondary ID(s)

MEC-2010-154

Source(s) of Monetary Support

ZON-MW, The Netherlands Organization for Health Research and Development, Nederlands Instituut voor Sport en Beweging (NISB)