Status:
UNKNOWN
Exercise Dose-response for Diabetes in the Elderly
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborating Sponsors:
Federal University of Rio Grande do Sul
Conditions:
Type2 Diabetes
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
One-center randomized, three-arm, parallel, superiority, controlled trial in 132 elderly outpatients with type 2 diabetes. Two different combined exercise training doses (300min/week vs 150min/week) w...
Detailed Description
This study is a randomized controlled trial, three-arm parallel-group. The first aim is to evaluate the efficacy of a supervised and structured combined exercise training program in HbA1c levels at 24...
Eligibility Criteria
Inclusion
- Previous diagnosis of type 2 diabetes mellitus by HbA1c (\> 6.5%) or capillary casual glycemia (\> 126 mg/dL), oral glucose tolerance test or hypoglycemic drug use;
- HbA1c ≥ 7.5%;
- Verified ability to exercise;
- Physically inactive or regularly exercising for at least once a week.
Exclusion
- HbA1c ≤ 12%;
- Severe cardiovascular disease (class III or IV heart failure, uncontrolled arrhythmia, unstable angina, or use of implantable cardioverter defibrillator);
- Major cardiovascular events 1 year previously to the enrollment (non-fatal myocardial infarction, coronary artery bypass surgery, cardiac catheterization, deep vein thrombosis, hospitalization or other severe health-related event);
- Chronic renal disease requesting dialysis;
- Severe macular injury (retinopathy) that disables patients to enroll an exercise program;
- Severe cognitive impairment (dementia) that disables patients to enroll an exercise program;
- Deafness that disables patients to enroll an exercise program;
- Blindness that disables patients to enroll an exercise program;
- Progressive neurological disorders (Parkinson, multiple sclerosis, etc.) that disables patients to enroll an exercise program;
- Osteoarticular or muscular injuries or another health conditions which generate inability to carry on the interventions;
- Plans of moving to another city during the study;
- Living together with another person enrolled in the study;
- A medical report indicating exercise contraindication based on a cardiopulmonary exercise testing;
- Inability or refusal to give written consent.
Key Trial Info
Start Date :
September 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT03423108
Start Date
September 10 2018
End Date
August 1 2020
Last Update
September 6 2018
Active Locations (1)
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1
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil