|- candidate number||9070|
|- NTR Number||NTR2734|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-feb-2011|
|- Secondary IDs||NL33834.008.10 CCMO|
|- Public Title||Exercise intervention for people with type 2 Diabetes Mellitus.|
|- Scientific Title||The effects of a self-efficacy based exercise intervention on physical activity, cardiovascular risk factors and health status in inactive people with type 2 Diabetes Mellitus.|
|- hypothesis||1. Effect on physical activity: It is hypothesized that both
interventions will increase the level of physical activity compared to care-as-usual;|
2. Successful change of the level of physical activity: It is
hypothesized that particularly a high level of exercise self-efficacy, low BMI and low depression at baseline are related to a successful change of the amount of physical activity in the intervention groups;
3. Effect on health status: It is hypothesized that health status (both the physical and mental component) will improve in the intervention groups compared to care-as-usual;
4. Effects on cardiovascular risk factors: It is hypothesized that BMI, waist-hip ratio and blood pressure will improve in the intervention groups compared to care-as-usual.
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II)|
|- Inclusion criteria||1. Type 2 Diabetes Mellitus;|
2. Exercising less than advised in the Dutch Guidelines for Physical Activity (i.e.< 30 minutes/day, 5 days/week);
3. BMI >25;
4. <80 years old.
In addition, participants of the intervention need to be
insured for medical costs with CZ health care insurance. Participants that are not insured for medical costs with CZ health insurance are eligible for the control group.
|- Exclusion criteria||1. Suffering from a serious complication of diabetes or other disabling co-morbidity: E.g. unstable angina pectoris, heart failure, extremely high blood pressure (systolic> 200, diastolic>120), cerebrovascular accident, serious neuropathy, kidney failure, diabetic foot ulcer(s), proliferative retinopathy, a serious form of cancer, orthopaedic constraints, serious exertion hypertension, unstable coronary ischemia;|
2. Recent participation in an exercise program on an indication other than diabetes.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-feb-2009|
|- planned closingdate||1-mrt-2013|
|- Target number of participants||944|
1. Phase 1: Assessment of exercise self-efficacy.
Participants are asked whether they believe that they can independently increase their exercise levels, without help from others (level of self-efficacy);
2. Phase 2:
A. Participants with a high level of exercise self-efficacy receive a patient-tailored exercise plan. This consists of an intake and three individual consultations with a physiotherapist. These participants are supposed to exercise at home (at least 3 times a week). Progression is evaluated at the individual consultations;
B. Participants with low levels of exercise self-efficacy receive a more intensive exercise intervention. This consists of an intake, group exercises supervised by a physiotherapist (first 8 weeks: 2x/week, 1 hour each time; next 8 weeks: 1x/week, 1 hour each time), at-home exercise (first 8 weeks: 1x/week; next 8 weeks: 2x/week; last 8 weeks: 3x/week) and two individual consultations in which progression is evaluated.
Control: Care as usual.
|- Primary outcome||1. Physical activity;|
2. Cardiovascular risk factors (such as BMI and Hba1c);
3. Health status.
|- Secondary outcome||1. Patient satisfaction;|
2. Diabetes self-efficacy;
3. Depressive symptoms;
4. Quality of sleep.
|- Timepoints||1. Baseline;|
2. After 12 weeks;
3. After 24 weeks;
4. After 36 weeks;
5. After 1 year;
6. After 1 year and 36 weeks.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Marion Heijden, van der|
|- CONTACT for SCIENTIFIC QUERIES|| Marion Heijden, van der|
|- Sponsor/Initiator ||University of Tilburg , POZOB, CZ, health insurance company|
(Source(s) of Monetary or Material Support)
|- Brief summary||Recruitment: The Netherlands.
Sufficient exercise is important for people with Type 2 Diabetes Mellitus, as it can prevent future health problems. Still, the majority of people with type 2 Diabetes Mellitus do not exercise enough. 376 people with type 2 Diabetes Mellitus – who exercise less than advised in the Dutch Guidelines for Physical Activity – will be included in a program, with the aim to support them to increase their level of exercise and improve health related quality of life, diabetes parameters, physical fitness, quality of sleep, depression and quality of care.
Participants who are confident that they can independently increase their amount of exercise (represented by a high exercise-self-efficacy score), receive a patient-tailored exercise plan. This plan will be carried out at home, by the patient. Participants who are not convinced that they can increase their amount of exercise independently (represented by a low exercise-self-efficacy score) receive a more intensive exercise intervention under supervision of a physiotherapist. 568 people will be included in a ‘care as usual’ matched control group.
|- Main changes (audit trail)|
|- RECORD||4-feb-2011 - 19-feb-2011|