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Bewegingstherapie via het internet voor patienten met type 2 diabetes.


- candidate number7790
- NTR NumberNTR2225
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-feb-2010
- Secondary IDsMEC-2009-230 MEC Erasmus MC
- Public TitleBewegingstherapie via het internet voor patienten met type 2 diabetes.
- Scientific TitleInteractive exercise therapy at home: A web based solution to improve long-term adherence, self-management and clinical efficacy of a life-style intervention program for patients with type 2 diabetes.
- ACRONYMWeb based interactive exercise therapy for Type 2 Diabetes
- hypothesisRegular exercise has been recommended for diabetes patients for many years, and has been identified along with diet and insulin as one of the three components of good therapy. From a physiological perspective, structured exercise interventions have at least equal therapeutic strength as currently applied pharmaceutical solutions aimed to improve glycemic control and cardiovascular risk profile. Despite this growing body of evidence showing the health benefits of exercise in type 2 diabetes, recently published surveys show that the majority of patients with diabetes do not engage in regular physical activity. This study investigates the feasibility of an online interactive exercise therapy to improve movement-related everyday activity/energy expenditure and functional capacity, muscle strength and resistance to fatigue.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteria1. Type 2 diabetes <15 years;
2. HbA1c: 7.0- 10.0%;
3. Age: 35-75 yrs;
4. BMI: 27-40 kg/m2;
5. Access to broadband internet including a personal computer with USB-interface.
- Exclusion criteria1. Cardio-vascular disease;
2. Severe orthopaedic impairments;
3. Renal failure or >grade III retinopathy or previous diabetic foot ulcer;
4. Cerebro-vascular disease (CVA), neurological diseases or deficits.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2010
- planned closingdate1-jan-2013
- Target number of participants48
- InterventionsPatients will be randomized to follow either a supervised progressive interval endurance and resistance type of training at the ErasmusMC (13 weeks) combined with an interactive web based (LiveWorkout®) resistance training at home (26 weeks), or to take part in a webbased activity monitor based lifestyle coaching program (26 weeks). Both programs are aimed at increasing daily physical activity levels.
- Primary outcomeAdherence to the exercise program as measured by percentage of dropouts as well as an increase in total weekly energy expenditure. The feasibility of the LiveWorkout and Direct Live program.
- Secondary outcome1. Movement-related everyday activity/energy expenditure and functional capacity Muscle strength and resistance to fatigue;
2. Glycemic control (HbA1c) and fasting plasma glucose;
3. Cardiovascular risk profile.
- TimepointsAll patients will be seen 3 times (in total approximately 3.5 hrs) before and after the intervention. Measurements that will be done during those visits are: questionnaires (PAR-Q, SF-36, specifically designed LiveWorkout users questionnaire), body composition, blood pressure, spiroergometry, muscle strength (upper arm and leg), Sit to Stand-test, fasting blood sample (3x7 ml). Patients will be asked to wear a small accelerometry-based Activity Monitor for 7 days and register movement related activities (7 days) as well as dietary intake (3 days).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES D. Visser
- CONTACT for SCIENTIFIC QUERIESDr. S.F.E. Praet
- Sponsor/Initiator Erasmus Medical Center, Department of Rehabilitation Medicine
- Funding
(Source(s) of Monetary or Material Support)
Wetenschappelijk College Fysiotherapie (WCF)
- PublicationsN/A
- Brief summaryPhysical exercise training is an important tool for improving glucose homeostasis in type 2 diabetic patients. A combined strength- and endurance training program appears to improve functional capacity, body composition and metabolic control in type 2 diabetes patients. However, long-term adherence to such programs is generally poor. Therefore, alternative strategies are warranted to reduce attrition rate.

Objective: (1) Does online supervised exercise therapy using the LiveWorkout concept result in better adherence to therapeutic bouts of exercise in type 2 diabetes patients as compared to Direct Life online lifestyle coaching. Are the LiveWorkout and Direct Life concepts feasible e-coaching programs? (2) Will online exercise training as compared to an online lifestyle coaching program cause an improvement in: movement-related everyday activity/energy expenditure and functional capacity, muscle strength and resistance to fatigue. (3) Does online exercise training as compared to usual care improve glycemic control (HbA1c), fasting plasma glucose levels and cardiovascular risk profile?
Patients will be randomized to follow either a supervised progressive interval endurance and resistance type of training at the ErasmusMC (13 weeks) combined with an interactive web based (LiveWorkout®) resistance training at home (26 weeks), or to take part in a webbased activity monitor based lifestyle coaching program (26 weeks). Both programs are aimed at increasing daily physical activity levels. All patients will be seen 3 times (in total approximately 3.5 hrs) before and after the intervention. Measurements that will be done during those visits are: questionnaires (PAR-Q, SF-36, specifically designed LiveWorkout users questionnaire), body composition, blood pressure, spiroergometry, muscle strength (upper arm and leg), Sit to Stand-test, fasting blood sample (3x7 ml). Patients will be asked to wear a small accelerometry-based Activity Monitor for 7 days and register movement related activities (7 days) as well as dietary intake (3 days).
- Main changes (audit trail)
- RECORD25-feb-2010 - 5-mrt-2010


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