Table 2 Exclusion criteria
From: The Intensive Diet and Exercise for Arthritis (IDEA) trial: design and rationale
Criteria | Exclusion | Method |
|---|---|---|
Significant co-morbid disease that would pose a safety threat or impair ability to participate, previous acute knee injury, patellofemoral OA in the absence of tibiofemoral OA | Symptomatic or severe coronary artery disease; severe HTN; active cancer, other than skin cancer; anemia; dementia; liver disease; COPD; peripheral vascular disease; inability to walk without an assistive device; blindness; osteoporosis, ligament or cartilage damage from acute event; type 1 diabetes; type 2 diabetes on thiazolidinediones agents; patellofemoral OA without tibiofemoral OA. | Medical history; physical exam; GXT; knee x-ray sunrise view |
Ability and willingness to modify dietary or exercise behaviors | Unwillingness or inability to change eating and physical activity habits due to environment; cannot speak and read English | Questionnaire, assessment by interventionists |
Excess alcohol use | ≥ 21 drinks per week | Questionnaire |
Inability to finish 18-month study or unlikely to be compliant | Lives > 50 miles from site or planning to leave area ≥ 3 months during the next 18 months | Questionnaire |
Conditions that prohibit knee MRI | Pacemaker, severe claustrophobia, defibrillator, implanted metal objects in leg, neurostimulator, magnetic aneurysm clip, any kind of metal implant or foreign metal objects in the body, such as bullets, shrapnel, metal slivers | Medical history |
Significant cognitive impairment or depression | diagnosis of dementia or a Modified Mini-Mental State exam (3MSE) score < 70, CES-D score > 17 | Medical history, 3MSE, CES-D |