Status:
UNKNOWN
Implementation of a Multi-component, Supervised Exercise Program for Patients With Type 2 Diabetes Mellitus.
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Diabetes Mellitus, Type 2
Exercise
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This quality improvement study aims to implement a supervised, multi-component exercise program for patients type 2 diabetes mellitus (T2DM) from a primary care practice. Rosemount Clinic patients wit...
Detailed Description
The Canadian Diabetes Association 2018 Clinical Practice Guidelines state that moderate to high levels of physical activity and cardiorespiratory fitness are associated with substantially lower morbid...
Eligibility Criteria
Inclusion
- Adult (age \>= 18 years) patients rostered with one of the Rosemount Clinic physicians with a clinical diagnosis of type 2 diabetes mellitus (fasting plasma glucose of \>= 7.0 mmol/L, a 2-hour plasma glucose value in a 75 g oral glucose tolerance test of \>= 11.1 mmol/L or a glycated hemoglobin (A1C) of \>= 6.5%).
Exclusion
- Exclusion criteria are primarily based off of those employed in the Look AHEAD (Action for Health in Diabetes) trial. The Look AHEAD trial is the largest randomized trial to date evaluating the efficacy of a physical activity and dietary control intervention in older adults with type 2 diabetes (Espeland, M. et al. 2003. Look AHEAD \[Action for Health in Diabetes\]: design and methods for a clinical trial of weight loss for the prevention of cardiovascular disease in type 2 diabetes. Controlled Clinical Trials. 24:610-628.).
- Pregnant
- A1C \> 11%
- Blood pressure \>= 160/100 mmHg
- Fasting triglycerides \>= 600 mg/dL
- Underlying diseases that may limit life span and/or affect the safety of the intervention:
- Currently pregnant or less than 3 months post-partum
- CVD event within the past 3 months (STEMI or NSTEMI)
- CVD manifesting any of the following criteria: Unstable angina pectoris or angina pectoris at rest, positive cardiac stress testing without completed work up or intervention, history of cardiac arrest, complex ventricular arrhythmia at rest or with exercise, uncontrolled atrial fibrillation (heart rate of 100 beats per minute or more), New York Heart Association Class III or IV congestive heart failure, acute myocarditis, pericarditis, hypertrophic cardiomyopathy, clinically significant aortic stenosis, cardiac pacemaker - unless approved by a Cardiologist, implantable cardioverter defribrillator (ICD) device in situ, history of aortic aneurysm of at least 7 cm in diameter or aortic aneurysm repair, resting heart rate \< 45 beats per minute or \> 100 beats per minute, or heart transplantation.
- Documented history of pulmonary embolus in past 6 months
- Currently undergoing active cancer treatment
- Renal disease manifesting any of the following criteria: Urine dipstick protein 4+, rerum creatinine \> 124 µmol/L (female) or \> 133 µmol/L (male), or currently receiving dialysis
- Untreated proliferative neuropathy
- Actively infected foot ulcer
- Chronic obstructive pulmonary disease that would limit ability to participate in intervention
- Chronic hepatitis B or C cirrhosis
- Inflammatory bowel disease requiring corticosteroid treatment for acute flare within the past year
- Endocrine disorder: Type 1 Diabetes, Cushing's syndrome or acromegaly
- Any major organ transplant
- HIV-positive
- Active tuberculosis
- Factors that may limit adherence to intervention: Inability to walk two blocks, lack of fluency in spoken English or French, hospitalization for depression in past 6 months, current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder, self-report of alcohol or substance use disorder within the past 12 months, or lack of support from Rosemount Clinic physician.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04030364
Start Date
September 1 2019
End Date
February 1 2020
Last Update
September 6 2019
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