Primary Objectives: - DirectLifeDirectLifeAre the LiveWorkout® and DirectLife® concept feasible web based training programs for type 2 diabetes patients ?- How do type 2 diabetes patients experience web based training intervention programs ? What…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Adherence 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 Live Workout program.
Secondary outcome
Movement-related everyday activity/energy expenditure and functional capacity
Muscle strength and resistance to fatigue
Glycemic control (HbA1c) and fasting plasma glucose
Cardiovascular risk profile
Background summary
Physical 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.
Study objective
Primary Objectives:
- DirectLifeDirectLifeAre the LiveWorkout® and DirectLife® concept feasible web
based training programs for type 2 diabetes patients ?
- How do type 2 diabetes patients experience web based training intervention
programs ? What can be recommended for future web based training interventions
to increase effectively ?
- What barriers experience patients who are not willing to engage in web based
training intervention programs ?
Secondary Objectives:
- Will online exercise training as compared to a usual care program cause an
improvement in:
- Movement-related everyday activity/energy expenditure and functional capacity
- Muscle strength and resistance to fatigue
- Glycemic control (HbA1c) and fasting plasma glucose levels
- Cardiovascular risk profile
• Is there a difference in adherence between the LiveWorkOut® and DirectLife®
group ?
care improve glycemic control (HbA1c), fasting plasma glucose levels and
cardiovascular risk profile?
Study design
A randomized controlled intervention study
Intervention
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.
Study burden and risks
Since all patients will undergo a symptom limited exercise stress test using
ECG-monitoring, the risk for exercise related cardiac ischaemia and/or
arrhythmia during the course of the exercise intervention is rather limited. To
minimize the risk for a hypoglycemic event, capillary blood glucose following
interval endurance training will be measured during the first 2 weeks of the
exercise intervention. The exercise intervention is expected to improve
glycemic control, blood pressure and workload capacity/physical fitness level.
As such, cardiovascular risk profile, general health and well-being is expected
to improve in the experimental group. 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).
Westzeedijk 361
Rotterdam 3000 CA
NL
Westzeedijk 361
Rotterdam 3000 CA
NL
Listed location countries
Age
Inclusion criteria
- Type 2 diabetes 3 maanden-15 years
- Age: 35-75 yrs
- Access to broadband internet including a personal computer with minimally WindowsXP/MacOSX and a USB-connection
Exclusion criteria
- Cardio-vascular disease
- Severe orthopaedic impairments
- Renal failure or >grade III retinopathy
- Previous diabetic foot ulcer that limits exercise training
- Cerebro-vascular disease (CVA), neurological diseases or deficits
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL28342.078.09 |