11/5/2011. Disclosure. Evidence Based Medicine (EBM) ADAPT Clinical Outcomes. 18-month Clinical Outcomes

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1 11/5/2011 and for Arthritis (IDEA) : 18-month Clinical Outcomes Disclosure Messier, S.P., Nicklas, B., Legault, C., Mihalko, S., Miller, G.D., DeVita, P., Hunter, D.J., Eckstein, F., Williamson, J.D., Carr, J., Lyles, M., Loeser, R. I have the following financial relationship(s) to disclose: Supplied the meal replacements (Lean Shakes) for the participants Evidence Based Medicine (EBM) IDEA Research Team Clinical Data Published in a Scientific Journal: Ettinger, W.H., et al. A randomized trial comparing aerobic exercise and resistance exercise to a health education program on physical disability in older people with knee osteoarthritis: The fitness' arthritis' and seniors trial (FAST). Journal of the American Medical Association.1997; 227: Carr DeVita Eckstein Guermazi Hunter Legault Expert Opinion: Messier, S.P. Invited commentary on Effects of dietary Intervention and quadriceps strengthening exercises on pain and function in overweight people with knee pain: randomized controlled trial. by Jenkinson et al. BMJ Evidence-Based Medicine Feb;15(1):21-2. Review Articles: Brosseau,L., et al. Ottawa panel evidence based clinical practice guidelines in the management of osteoarthritis in obese and overweight adults. Physical Therapy Journal.2011:91, Loeser Lyles Mihalko Miller Nicklas Williamson ADAPT Clinical Outcomes Pain Function WOMAC Pain 8.0 more Healthy Lifestyle Control * less Summary WOMAC Function Score 28 worse Healthy Lifestyle Control + * better Messier et al., Arthritis Rheum,

2 11/5/2011 Medial Joint Space Width Group Baseline 18 months Healthy Lifestyle 3.18 mm (0.21) 3.18mm (0.18) 3.37 mm (0.19) mm (0.23) 2.93 mm (0.20) 2.98 mm (0.17) 3.18 mm (0.21) 2.93 mm (0.21) % Intense Weight Loss Can we achieve even greater long term weight loss, 2-3 times what we achieved in ADAPT and would this impact the osteoarthritis disease pathways such that : No significant difference in disease progression Disease progression is altered Obese PATHWAYS Adults TO with KNEE Knee OA Pain reduced Mechanical pathway Weight Loss and Inflammatory pathway Decreased Joint Loads Decreased Inflammatory Cytokine Activity Decreased Subchondral Tissue Damage Less Cartilage Loss, Less Synovitis Function improved beyond what has been previously shown Decreased PAIN Improved mobility Greater strength/power Diseased Progression Mechanical pathway Obese PATHWAYS Adults TO with KNEE Knee OA OA Decreased Joint Loads Decreased Subchondral Tissue Damage Weight Loss and Decreased PAIN Improved mobility Greater strength/power Diseased Progression Decreased Inflammatory Cytokine Activity Inflammatory pathway Less Cartilage Loss, Less Synovitis IDEA Intervention Groups (Control) + 20 MIN. weight training ary 10% WEIGHT LOSS OVER 18 MONTHS ary Plus 2

3 11/5/2011 IDEA Intervention + 20 MIN. weight training ary 10% WEIGHT LOSS OVER 18 MONTHS ary Plus IDEA Nutrition Intervention Initial energy intake deficit of kcals/day Up to 2 meal replacements (300 kcals each) per day GNC Lean Shakes Third meal between kcals (low in fat) Weight loss goal: 10% body weight over 18 months Meetings: weekly/0-6 months Biweekly/7-18 months Inclusion Criteria IDEA Participant Progress Total Persons Pre-Screened N = 2995 Age 55 yrs. 27 BMI 40.5 kg/m 2 Sedentary lifestyle K-L = 2-3 radiographic tibiofemoral OA Permitted to maintain usual medications Received (control) N =150 Follow-up Visits 6 mo (N =130 ) 18 mo (N =134 ) Completed Not Enrolled/Randomized (N = 2541) Ineligible=1076 Declined=1082 Enrolled/Randomized N = 454 Received N =152 Follow-up Visits 6 mo (N =123 ) 18 mo (N =129 ) Completed Received + N =152 Follow-up Visits 6 mo (N =138 ) 18 mo (N =136 ) Completed N =134 (89%) N =129 (85%) N =136 (89%) Participant Characteristics Weight Change (N = 152) (N = 150) + (N = 152) Mean Age (yrs) Female (%) BMI Race (% white) No differences between groups Weight (kg) across 18 months E D D+E Group Time Mean (kg) base Exer Change (kg) % Change FU FU base 93.0 FU FU Exer base 92.3 FU FU

4 Weight loss (%) 11/5/2011 Weight loss by month Lean and Fat Mass Change + Weight loss (lbs) Group Time Body Wt (kg) +Exer Lean, kg (% loss) % lean Fat, kg (% loss) % fat base FU (-8%) (-13%) 38 base FU (-9%) (-18%) 37 base FU (-5%) (-<1%) 41 Pain vs. Time Pain vs. Time More pain More pain WOMAC Pain (range 0-20) % Change *P = WOMAC Pain (range 0-20) *P = Less pain Little or no pain D+E D E 38% 20% 22% Function 25 (range 0-68) 20 WOMAC Function vs. Time Worse function Better function + *P = Baseline 6 Month Month % Change Walk Speed vs. Time Walk Speed (m/s) *P = *1.34 *1.30 *1.30 4

5 % change walk speed 11/5/ Himann et al., MSSE, Age (yrs) Mean: yrs men Mean: yrs women Summary Long term intensive weight loss is possible in an OA population All groups showed improvements in pain and function at 6 months Clinicians can tell their patients that they will see marked improvement in 6 months or less Summary Significant between group differences did not appear until 18 months This underscores the need for long term studies to detect clinically and statistically meaningful results. All 3 groups also had long term improvements mobility, pain, and function The diet plus exercise group was superior on virtually all clinical measures Take home message You can reduce your pain by 50%, and improve your mobility and function with long term intensive diet and moderate exercise FAST TRIAL SUMMARY DISABILITY SCORE more Health Education Resistance Disability 1.7 Aerobic less Ettinger et al., JAMA, MONTH as Standard-of Care 5

6 Weight loss (%) Weight loss (%) 11/5/2011 Physical Activity Scale for the Elderly 160 More active 150 PASE 140 (range:0-300) men women P = % Change Less active =Norms: Washburn et al. JCE, Baseline 6 Month Month 6 minute walk distance Group Time Mean (m) baseline 475 Change (m) %Change FU FU Exer baseline 466 FU FU18 548* Exer baseline 480 FU FU18 531* adjusted for gender, BMI, baseline values *p< compared to only SF-36 (range 0-100) adjusted 18-month data Best health baseline baseline US Norms ages yrs 6