Status:
COMPLETED
Light Intensity Physical Activity Trial
Lead Sponsor:
Academisch Ziekenhuis Maastricht
Collaborating Sponsors:
European Foundation for the Study of Diabetes
Conditions:
Diabetes Mellitus
Physical Exercise
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
In type 2 diabetes (T2D), physical activity is an important modifiable risk factor of cardiovascular disease (CVD). Unfortunately (long-term) compliance to exercise programs in patients with T2D is po...
Detailed Description
Total duration of the RCT is 12 months, with the first 6 month as the intervention period and the last 6 months as follow-up. Community-dwelling individuals with type 2 diabetes are eligible for part...
Eligibility Criteria
Inclusion
- 40-70 years old
- having type 2 diabetes
- BMI 20-35 kg/m2
- having a sedentary lifestyle (i.e., self-reported moderate-to-vigorous physical activity \< 150 minutes per week)
- willingness to undergo randomization
- being in the possession of personally owned smart phone
Exclusion
- not being able to walk for 15 minutes for any (medical) reason
- currently engaged in an (medical) exercise program
- plan to move out of the study area in the next 12 months
- (digital) illiteracy or being unable to read Dutch
- a history of any cardiovascular event (including stroke) three months prior to possible inclusion
- a history of signs or symptoms of ischemic heart disease and(or) heart failure three months prior to possible inclusion
- a history or signs or symptoms of peripheral arterial disease three months prior to possible inclusion
- a history or signs or symptoms of severe diabetic neuropathy or diabetic foot ulcers three months prior to possible inclusion
- a history of sign or symptoms of severe diabetic retinopathy three months prior to possible inclusion
- a history or sign or symptoms of severe osteoarthritis or severe joint complaints three months prior to possible inclusion
- a history or signs or symptoms of COPD (eligible are those participants with a COPD Gold classification ≤ I)
- uncontrolled diabetes (i.e., uncontrolled hypo- or hyperglycaemia)
- uncontrolled hypertension (i.e., systolic / diastolic blood pressure ≥ 180 / 95 mmHg)
Key Trial Info
Start Date :
November 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2022
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT03415880
Start Date
November 8 2018
End Date
February 15 2022
Last Update
February 2 2023
Active Locations (1)
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1
Maastricht University
Maastricht, Netherlands