Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
The effect of a LiPA intervention program on reducing aortic carotid-to-femoral pulse-wave velocity (PWV) in patients with type 2 diabetes. |
Aortic (carotid to femoral) PWV will be determined by means of applanation tonometry. It will be calculated as the median of three consecutive PWV recordings. |
Change from baseline PWV at 6 months. |
|
Primary |
The effect of a LiPA intervention program on increasing carotid distensibility in patients with type 2 diabetes. |
Carotid distensibility will be determined at the left common carotid by means of arterial ultrasound. |
Change from baseline carotid distensibility at 6 months. |
|
Secondary |
Feasibility of a LiPA intervention program on reducing sedentary time as measured by activPAL |
Daily activity levels will be measured by activPAL3™ physical activity monitor. The participants will wear the device fixated on their upper leg for 8 consecutive days at each measurement moment. ActivPAL measures total standing time, sedentary time (sitting or lying down), and stepping time (physical activity). |
Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). |
|
Secondary |
The effect of a LiPA intervention on changes in blood pressure. |
Measurement of any changes in blood pressure |
Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). |
|
Secondary |
The effect of a LiPA intervention on waist -circumference in cm. |
Measurement of any changes in waist -circumference |
Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). |
|
Secondary |
The effect of a LiPA intervention on quality of life as measured through the Dutch versions of the EQ-5D questionnaire. |
The EQ-5D is a short questionnaire that covers five dimensions of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort and Anxiety/Depression. The EQ-5D includes 5 questions with 5 answer options each, ranging from 1 ('no problems') to 5 ('severe limitation'). A summary index with a maximum score of 1 can be computed from these five dimensions by means of a converion table. A score of 1 indicates the best health status. Additionally, there is a visual analogue scale (VAS) to indicate the general health status with scores ranging from 0 ('the worst health you can imagine') to 100 ('the best health you can imagine'). |
Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). |
|
Secondary |
The effect of a LiPA intervention on depressive symptoms with the use a validated Dutch version of the 9-item Patient Health Questionnaire (PHQ-9). |
The PHQ-9 is a self-administered questionnaire based on the DMS-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for a major depressive disorder. It comprises nine items rated on a 4-point scale, ranging from 0 = "not at all" to 3 = "nearly every day". The PHQ-9 scale will also be used as a dichotomous variable with a pre-defined cut-off level of 10, which represents the presence of clinically relevant depressive symptoms. |
Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). |
|
Secondary |
Feasibility of a LiPA intervention program on increasing standing and stepping time as measured by activPAL. |
Daily activity levels will be measured by activPAL3™ physical activity monitor. The participants will wear the device fixated on their upper leg for 8 consecutive days at each measurement moment. ActivPAL measures total standing time, sedentary time (sitting or lying down), and stepping time (physical activity). Stepping time (physical activity) is further classified into higher intensity physical activity (minutes with a step frequency >110 steps/min during waking time) and lower intensity physical activity (minutes with a step frequency =110 steps/min during waking time). |
Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). |
|
Secondary |
The effect of a LiPA intervention on fasting blood glucose |
Measurement of any changes in fasting blood glucose. |
Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). |
|
Secondary |
The effect of a LiPA intervention on HbA1c. |
Measurement of any changes in HbA1c. |
Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). |
|
Secondary |
The effect of a LiPA intervention on total cholesterol. |
Measurement of any changes in total cholesterol. |
Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). |
|
Secondary |
The effect of a LiPA intervention on HDL- and LDL-cholesterol. |
Measurement of any changes in HDL- and LDL-cholesterol. |
Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). |
|
Secondary |
The effect of a LiPA intervention on triglycerides. |
Measurement of any changes in triglycerides |
Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). |
|
Secondary |
The effect of a LiPA intervention on glucose lowering medication. |
Measurement of any changes in glucose lowering medication. |
Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). |
|
Secondary |
The effect of a LiPA intervention on hip -circumference in cm. |
Measurement of any changes in hip -circumference |
Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). |
|
Secondary |
The effect of a LiPA intervention on body composition |
Measurement of any changes in body composition as measured by bio electrical impedance. |
Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). |
|
Secondary |
The effect of a LiPA intervention on quality of life as measured through the Dutch version of the SF-36 questionnaire. |
The SF-36 is a generic and easily self-administered quality of life instrument. The SF-36 questionnaire measures health on eight multi-item dimensions, covering functional status, well-being, and overall evaluation of health. In six of these eight dimensions, participants rate their responses on a three or six point scale. For each dimension, item scores are coded, summed, and transformed on to a scale from 0 (worst health) to 100 (best health). |
Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). |
|
Secondary |
The effect of a LiPA intervention program on immune cells. |
Measurement of circulating immune cells using flow cytometry from fresh whole blood. In addition, measurement of circulating cytokines to assess the activation state of immune cells, and store immune cells for functional tests. |
Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). |
|
Secondary |
The effect of a LiPA intervention program on microvascular function |
Microvascular function will be evaluated in both the retina and the skin. Which will be determined with the use of fundoscopy and Skin laser Doppler flowmetry. |
Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). |
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