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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