|- candidate number||4261|
|- NTR Number||NTR1501|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-okt-2008|
|- Secondary IDs||0436 Number MECC Slotervaarthospital|
|- Public Title||Diabetes Lifestyle Intervention Study Slotervaarthospital|
|- Scientific Title||The effects of a behavior change lifestyle intervention program on physical activity and clinical parameters of diabetes in patients with insulin dependent type 2 diabetes mellitus
|- hypothesis||In patients with non-insulin dependent type 2 diabetes, intensive, short term physical activity is associated with decreased blood glucose levels and number of cardiovascular complications. In patients who are insulin dependent however, the effects of physical activity are less clear since few studies are conducted with only insulin dependent type 2 diabetes patients included. Moreover, short-term, intensive lifestyle interventions often fail to significantly improve physical activity in the long term because of high drop out rates. The aim of this study was to determine the sustainability and effects upon physical activity, HbA1c levels and other clinical parameters of type 2 diabetes of a 2-year, behavior intervention program in insulin dependent type 2 diabetes patients.|
|- Healt Condition(s) or Problem(s) studied|
|- Inclusion criteria||1. A clinical trial involving patients at the Dutch Slotervaart Hospital, who had type 2 diabetes and were using insulin. |
Subjects aged until 70 years and exercising less than 180 minutes per week, spread over at least three times per week, were included to the study.
|- Exclusion criteria||Eligible persons were excluded if they met one of the following conditions:|
1. Poor knowledge of the Dutch language
2. Life-expectancy of less than 5 years
3. Clinical manifest cardiovascular disease (hospitalization as a result of heart disease until 6 months before inclusion
4. Angina pectoris class ¡Ư II (NYHA)
5. Left heart-block or aorta-stenosis)
6. Pregnant women
7. Repeated hospitalization because of recurrent hypoglycaemia
8. Pre-terminal kidney-failure
9. Proliferative retinopathy
10. Usage of an insulin pump
11. Revalidation therapy
12. Psychiatric diseases
13. Chronic alcohol and/or drugs abuse
14. Decreased physical tolerance because of unrelated diabetic co-morbidity, like COPD or immune diseases.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2005|
|- planned closingdate||1-sep-2008|
|- Target number of participants||74|
|- Interventions||The intervention program was based on the PACE (Physician-based Assessment and Counseling for Exercise) program; to stimulate exercise in participants on low profile by written information, short personal advise and telephone follow-up.|
The program consisted of 4 visits per year at the physiotherapist and a 15-minute telephone call 6 weeks after each visit.
In the first consult, the physiotherapist and the subjects made a personal exercise program together based on the persons¡¯ baseline exercise pattern, medical condition, exercise tolerance and personal preferences.
The goal was for the participants to exercise at a medium intensive level, 160-180 minutes per week and spread over at least three times per week, based on the Diabetes Prevention Program.
During the following contacts, the subjects were instructed and encouraged to achieve or maintain the intended goal.
Participants in the control group received no individual advice, no programs were provided and no additional appointments were scheduled, apart from the visits for the annual measurements.
|- Primary outcome||Primary outcome measure was:|
- the change in physical activity measured by the Tecumseh/Minnesota scale.
|- Secondary outcome||Secondary outcome measures were:|
- differences in quality of life (W-BQ12 scale)
- medication use
- body composition
- laboratory markers of diabetes
- macro and microvascular complications.
|- Timepoints||The inclusion period was 1 year, from juli 2005 until juli 2006. |
Measurements of every individual were performed at baseline and after 1 and 2 years.
The study was finished in august 2008.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| Willeke Wisse|
|- CONTACT for SCIENTIFIC QUERIES|| Willeke Wisse|
|- Sponsor/Initiator ||Slotervaarthospital, Department of internal medicine: Diabetespoliclinic |
(Source(s) of Monetary or Material Support)
|Novo Nordisk Farma B.V. |
|- Brief summary||Objective: In patients with non-insulin dependent diabetes type 2, intensive, short term physical activity is associated with decreased blood glucose levels and number of cardiovascular complications. In patients who are insulin dependent however, the effects of physical activity are less clear. Moreover, short-term, intensive lifestyle interventions often fail to significantly improve physical activity in the long term. The aim of this study was to determine the sustainability and effects upon physical activity and effects on HbA1c levels and other clinical parameters of diabetes of a 2-year behavior intervention program in insulin dependent patients with diabetes type 2.|
|- Main changes (audit trail)|
|- RECORD||21-okt-2008 - 31-okt-2008|