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.

Recruiting

Conditions: Diabetes type 2
10018424
adult onset diabetes

Registration Number: NL-OMON38219

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

•Type 2 diabetes > 3 months
•Signs of 2 or more diabetes-related 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 including (partial) foot amputations ie Lisfranc or Chopart amputations, lower leg amputations.)
•Stable diabetic foot problems and diabetic ulcers (not prohibiting participation in the training program or exercise test procedures)
•HbA1c: >7.0%
•Age: 30-80 yrs
•BMI > 27kg/m2
•Sedentary behaviour (i.e. <30 min/day moderately active assessed by activity monitoring)
•Agreement to volunteer for the study by giving a written informed consent

Exclusion Criteria

•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)
•Severe orthopaedic impairments that would prohibit participation in the training program
(eg severe diabetes ulcers of the foot, in case of amputations: inadequate prosthesis/footwear)
•Cerebro-vascular disease (CVA) or other neurological diseases or deficits that would prohibit participation in the training program (eg spasticity).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure evaluates the clinical efficacy of the intervention<br /><br>on the standard diabetes outcome parameter for glycemic control (HbA1c)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary diabetes related outcome measures evaluate the overall effect on<br /><br>health:<br /><br>-risk profile for cardiovascular disease (lipid profile, blood pressure)<br /><br>-body composition (BMI, waist circumference, regional fat distribution)<br /><br>-cardiorespiratory fitness (VO2peak)<br /><br>-functional capacity and muscle strength<br /><br>-health-related quality of life (SF-36)<br /><br>-level of depressive symptoms using the Centre for Epidemiologic Studies<br /><br>Depression Scale (CES-D)<br /><br>-Diabetes symptom distress (using the revised version of the Type 2 Diabetes<br /><br>Symptom Checklist</p><br>