A $6 million federal grant, the largest ever awarded to Wake Forest University, will enable health and exercise science researchers to further study knee osteoarthritis and successful treatment measures in community-based settings.
Health and exercise professor Steve Messier and colleagues have spent 26 of the last 34 years at Wake Forest studying the effects of exercise and dietary restriction related to knee osteoarthritis (OA) through clinical trials research. This new grant will fund a study known as WE-CAN - Weight Loss and Exercise for Communities with Arthritis in North Carolina - that will put these years of highly-controlled clinical study results to the test in a real-world setting.
"Knee osteoarthritis is a leading cause of disability in older adults and there are over 250 million people in the world affected," Messier said. "Our work has looked at effects of walking, strength training and weight loss on function and pain in OA under very controlled settings. We've decided to take what we've learned before and move it out in the community."
Armed with the grant from the National Institutes of Health's (NIH) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Messier and his team, which includes associate professors Gary Miller, a nutrition expert, and health psychologist Shannon Mihalko, both of the Health and Exercise Science department, are conducting what's known as a pragmatic clinical trial in which there are very few controls in order to simulate normal clinical conditions.
In January 2016, the researchers will begin recruiting 820 participants age 50 and over, who experience knee pain most days of the week to study over an 18-month intervention period. The participants will represent three diverse residential and socioeconomic groups from Forsyth, Haywood and Johnston counties. Half of the participants' will be randomized to an exercise (walking and weight training) and diet (with a goal of 10 percent body weight loss) group while the other half will be a successful aging control group.
The Wake Forest team is also working with co-investigators from the University of North Carolina at Chapel Hill, Brigham and Women's Hospital Harvard University, Wake Forest Health Sciences, East Carolina University, and the University of Sydney, Australia.
In 2013, the team published results in the Journal of American Medical Association (JAMA) from the IDEA randomized clinical trial showing that a combination of exercise and at least a 10 percent weight loss reduced chronic knee pain by more than 50 percent in overweight and obese adult patients with knee osteoarthritis. That's better than the average pharmacologic intervention of 30 percent reduction in pain in half of those treated, Messier said.
"Many physicians who treat people with knee OA have no practical means to implement weight loss and exercise treatments," he said. "We haven't provided doctors with the vehicle to help their patients be successful. This study is significant in that it will test the effectiveness of a long-awaited and much needed community-based program that will serve as a blueprint for clinicians and public health officials in both urban and rural communities."
Messier said it's not enough to just understand the clinical aspects of what decreases knee pain. He hopes they can develop a 'turn key' operation that can be implemented in locations such as church fellowship halls, recreation centers, workout gyms, and other community facilities where doctors can send their patients.
The idea that a community-based program like this could have a trifecta approach - weight loss and exercise are good for other co-morbidities like type 2 diabetes and hypertension - was one of the strengths of the grant application, as well as the plan to establish its cost effectiveness. If they can prove that it works and is also cost effective, then the model will be more attractive to insurance companies, he said.
For WE-CAN, Messier wants to see the same positive outcomes as the IDEA trial, but the main question will be whether participants can achieve those same results with less one-on-one interaction with interventionists. He's hopeful they will be able to demonstrate that community-based intervention programs can make a difference in people's lives and health.
"I've been doing this research for more than 25 years," he said. "If we can't do this and make this successful, I question what those 25 years were about."
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