The osteoarthritis prevention study (TOPS) - A randomized controlled trial of diet and exercise to prevent Knee Osteoarthritis: Design and rationale.

Background: Osteoarthritis (OA), the leading cause of disability among adults, has no cure and is associated with significant comorbidities. The premise of this randomized clinical trial is that, in a population at risk, a 48-month program of dietary weight loss and exercise will result in less incident structural knee OA compared to control. Methods/design: The Osteoarthritis Prevention Study (TOPS) is a Phase III, assessor-blinded, 48-month, parallel 2 arm, multicenter randomized clinical trial designed to reduce the incidence of structural knee OA. The study objective is to assess the effects of a dietary weight loss, exercise, and weight-loss maintenance program in preventing the development of structural knee OA in females at risk for the disease. TOPS will recruit 1230 ambulatory, community dwelling females with obesity (Body Mass Index (BMI) â€‹≥ â€‹30 â€‹kg/m2) and aged ≥50 years with no radiographic (Kellgren-Lawrence grade ≤1) and no magnetic resonance imaging (MRI) evidence of OA in the eligible knee, with no or infrequent knee pain. Incident structural knee OA (defined as tibiofemoral and/or patellofemoral OA on MRI) assessed at 48-months from intervention initiation using the MRI Osteoarthritis Knee Score (MOAKS) is the primary outcome. Secondary outcomes include knee pain, 6-min walk distance, health-related quality of life, knee joint loading during gait, inflammatory biomarkers, and self-efficacy. Cost effectiveness and budgetary impact analyses will determine the value and affordability of this intervention. Discussion: This study will assess the efficacy and cost effectiveness of a dietary weight loss, exercise, and weight-loss maintenance program designed to reduce incident knee OA. Trial registration: ClinicalTrials.gov Identifier: NCT05946044.

Severity of Overuse Injury Impacts Self-Efficacy and Quality of Life in Runners: A 2-Year Prospective Cohort Study.

CONTEXT: While 55 million Americans incorporate running into their exercise routines, up to 65% of runners sustain an overuse injury annually. It has been consistently shown that regular physical activity positively impacts quality of life (QOL), an essential public health indicator; however, the impact of running-related injuries on QOL is unknown. This study seeks to determine whether overuse injury severity impacts QOL in recreational runners, and if self-efficacy mediates this relationship. DESIGN: Community-based prospective cohort study of 300 runners who had been running injury free for at least 5 miles/wk in the past 6 months. METHODS: Self-efficacy for running and QOL measures (Short Form-12 Physical Component and Mental Component, Satisfaction with Life, Positive Affect and Negative Affect) were assessed at baseline, time of injury, and follow-up visits. Over 2 years of observation, overuse injuries were diagnosed by an orthopedic surgeon and injured runners were referred to a physical therapist. RESULTS: Injury severity was significantly (P < .01) related with 2 indices of QOL, such that the effect of injury severity was -2.28 units on the Short Form-12 physical component and -0.73 units on positive affect. Self-efficacy accounted for 19% and 48% of the indirect effects on Short Form-12 physical component and positive affect, respectively. CONCLUSIONS: Since self-efficacy is a modifiable factor related to decreased QOL, these findings have important clinical implications for rehabilitation interventions.

A 2-Year Prospective Cohort Study of Overuse Running Injuries: The Runners and Injury Longitudinal Study (TRAILS).

BACKGROUND: The National Center for Injury Prevention and Control, noting flaws in previous running injury research, called for more rigorous prospective designs and comprehensive analyses to define the origin of running injuries. PURPOSE: To determine the risk factors that differentiate recreational runners who remain uninjured from those diagnosed with an overuse running injury during a 2-year observational period. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: Inclusion criteria were running a minimum of 5 miles per week and being injury free for at least the past 6 months. Data were collected at baseline on training, medical and injury histories, demographics, anthropometrics, strength, gait biomechanics, and psychosocial variables. Injuries occurring over the 2-year observation period were diagnosed by an orthopaedic surgeon on the basis of predetermined definitions. RESULTS: Of the 300 runners who entered the study, 199 (66%) sustained at least 1 injury, including 73% of women and 62% of men. Of the injured runners, 111 (56%) sustained injuries more than once. In bivariate analyses, significant ( P ≤ .05) factors at baseline that predicted injury were as follows: Short Form Health Survey-12 mental component score (lower mental health-related quality of life), Positive and Negative Affect Scale negative affect score (more negative emotions), sex (higher percentage of women were injured), and knee stiffness (greater stiffness was associated with injury); subsequently, knee stiffness was the lone significant predictor of injury (odds ratio = 1.18) in a multivariable analysis. Flexibility, quadriceps angle, arch height, rearfoot motion, strength, footwear, and previous injury were not significant risk factors for injury. CONCLUSION: The results of this study indicate the following: (1) among recreational runners, women sustain injuries at a higher rate than men; (2) greater knee stiffness, more common in runners with higher body weights (≥80 kg), significantly increases the odds of sustaining an overuse running injury; and (3) contrary to several long-held beliefs, flexibility, arch height, quadriceps angle, rearfoot motion, lower extremity strength, weekly mileage, footwear, and previous injury are not significant etiologic factors across all overuse running injuries.