Disparities between rural and urban communities: Response to 18-months of diet and exercise versus control for knee osteoarthritis and overweight or obesity.

OBJECTIVES: The study objective was to determine whether the clinical response of older adults with knee osteoarthritis and overweight or obesity to 18 months of diet and exercise or attention control interventions differed between participants from rural versus urban communities. METHODS: Participants were 823 older adults (mean age, 64.6 years; 77% women) with knee osteoarthritis, overweight or obesity, who resided in rural (N = 410) and urban (N = 413) counties in North Carolina. All were enrolled in the WE-CAN clinical trial that randomly assigned participants to either 18-months of diet and exercise (D+E) or attention control (C) interventions. General linear models were used to examine differences in clinical outcomes between rural and urban groups after adjusting for covariates. RESULTS: The rural group had significant differences (P<.05) at baseline in clinical outcomes, education, comorbidities, medication use, and income compared to the urban dwellers. After adjusting for baseline differences, the group (rural, urban) by treatment (D+E, C) interactions for WOMAC pain (rural: D+E-C= -0.63,95%CI,-1.31 to 0.06; urban: D+E-C= -0.29,95%CI,-0.99 to 0.41;P=.50) and WOMAC function (rural: D+E-C = -4.60,95%CI,-6.89 to -2.31; urban: D+E-C = -1.38,95%CI,-3.73 to 0.94;P=.054) indicated that the groups responded similarly to the interventions. CONCLUSIONS: Among participants with knee osteoarthritis and overweight or obesity, diet and exercise compared to attention control led to similar pain outcomes in rural and urban dwellers that favored diet and exercise; the possibility there may be greater differential efficacy in functional outcomes among rural participants needs further study.

Budget impact of the Walk With Ease program for knee osteoarthritis.

Objective: Walk With Ease (WWE) is an effective low-cost walking program. We estimated the budget impact of implementing WWE in persons with knee osteoarthritis (OA) as a measure of affordability that can inform payers' funding decisions. Methods: We estimated changes in two-year healthcare costs with and without WWE. We used the Osteoarthritis Policy (OAPol) Model to estimate per-person medical expenditures. We estimated total and per-member-per-month (PMPM) costs of funding WWE for a hypothetical insurance plan with 75,000 members under two conditions: 1) all individuals aged 45+ with knee OA eligible for WWE, and 2) inactive and insufficiently active individuals aged 45+ with knee OA eligible. In sensitivity analyses, we varied WWE cost and efficacy and considered productivity costs. Results: With eligibility unrestricted by activity level, implementing WWE results in an additional $1,002,408 to the insurance plan over two years ($0.56 PMPM). With eligibility restricted to inactive and insufficiently active individuals, funding WWE results in an additional $571,931 over two years ($0.32 PMPM). In sensitivity analyses, when per-person costs of $10 to $1000 were added with 10-50% decreases in failure rate (enhanced sustainability of WWE benefits), two-year budget impact varied from $242,684 to $6,985,674 with unrestricted eligibility and from -$43,194 (cost-saving) to $4,484,122 with restricted eligibility. Conclusion: Along with the cost-effectiveness of WWE at widely accepted willingness-to-pay thresholds, these results can inform payers in deciding to fund WWE. In the absence of accepted thresholds to define affordability, these results can assist in comparing the affordability of WWE with other behavioral interventions.

Cost-Effectiveness of Community-Based Diet and Exercise for Patients with Knee Osteoarthritis and Obesity or Overweight.

OBJECTIVE: Obesity exacerbates pain and functional limitation in persons with knee osteoarthritis (OA). In the Weight Loss and Exercise for Communities with Arthritis in North Carolina (WE-CAN) study, a community-based diet and exercise (D + E) intervention led to an additional 6 kg weight loss and 20% greater pain relief in persons with knee OA and body mass index (BMI) >27 kg/m2 relative to a group-based health education (HE) intervention. We sought to determine the incremental cost-effectiveness of the usual care (UC), UC + HE, and UC + (D + E) programs, comparing each strategy with the "next-best" strategy ranked by increasing lifetime cost. METHODS: We used the Osteoarthritis Policy Model to project long-term clinical and economic benefits of the WE-CAN interventions. We considered three strategies: UC, UC + HE, and UC + (D + E). We derived cohort characteristics, weight, and pain reduction from the WE-CAN trial. Our outcomes included quality-adjusted life years (QALYs), cost, and incremental cost-effectiveness ratios (ICERs). RESULTS: In a cohort with mean age 65 years, BMI 37 kg/m2, and Western Ontario and McMaster Universities Osteoarthritis Index pain score 38 (scale 0-100, 100 = worst), UC leads to 9.36 QALYs/person, compared with 9.44 QALYs for UC + HE and 9.49 QALYS for UC + (D + E). The corresponding lifetime costs are $147,102, $148,139, and $151,478. From the societal perspective, UC + HE leads to an ICER of $12,700/QALY; adding D + E to UC leads to an ICER of $61,700/QALY. CONCLUSION: The community-based D + E program for persons with knee OA and BMI >27kg/m2 could be cost-effective for willingness-to-pay thresholds greater than $62,000/QALY. These findings suggest that incorporation of community-based D + E programs into OA care may be beneficial for public health.

The association between obesity, knee pain, and gait during stair descent in older adults with knee osteoarthritis.

BACKGROUND: Obesity and knee osteoarthritis adversely affect activities of daily living in older adults. Together, the complexities of their interaction on mobility, including stair negotiation, are unresolved. The purpose of this study was to determine the relationship between obesity, pain, and stair negotiation in older adults with knee osteoarthritis. METHODS: Older adults with symptomatic knee osteoarthritis and overweight or obesity participated in the study (n = 28; age range = 57.0-78.0 yrs.; body mass index range = 26.6-42.8 kg•m-2). The Western Ontario and McMaster Universities Osteoarthritis Index pain subscale was used to measure knee pain. Measurements included a three-dimensional biomechanical analysis during descent on a set of force plate-instrumented stairs and a timed stair descent test. Pearson's r was used to determine associations between body mass index and pain, stair descent weight-acceptance phase vertical ground reaction force (vGRF) variables and lower extremity joint kinematics and kinetics, and timed stair descent performance. FINDINGS: Significant correlations existed between body mass index and pain (r = 0.41; p = 0.03), peak vGRF (r = 0.39; p = 0.04), vertical impulse (r = 0.49; p = 0.008), and peak ankle plantar flexor moments (r = 0.50; p = 0.007) in older adults with knee osteoarthritis. INTERPRETATION: Greater obesity in older adults with knee osteoarthritis was associated with greater knee pain and higher ankle joint loads during stair descent. These results support the recommendations of osteoarthritis treatment guidelines for weight-loss as a first-line of treatment for older adults with obesity and knee osteoarthritis.

The metabolome of individuals with knee osteoarthritis is influenced by 18-months of an exercise and weight loss intervention and sex: the IDEA trial.

Objective: The Intensive Diet and Exercise for Arthritis (IDEA) trial was conducted to evaluate the effects of diet and exercise on osteoarthritis (OA), the most prevalent form of arthritis. Various risk factors, such as obesity and sex, contribute to the debilitating nature of OA. While diet and exercise are known to improve OA symptoms, cellular and molecular mechanisms underlying these interventions, as well as effects of participant sex, remain elusive. Methods: Serum was obtained at three timepoints from IDEA participants assigned to groups of diet, exercise, or combined diet and exercise (n=10 per group). All serum metabolites were extracted and analyzed via liquid chromatography-mass spectrometry combined with metabolomic profiling. Extracted serum was pooled and fragmentation patterns were analyzed to identify metabolites that statistically differentially regulated between groups. Results: Changes in metabolism across male and female IDEA participants after 18-months of diet, exercise, and combined diet and excise intervention mapped to lipid, amino acid, carbohydrate, vitamin, and matrix metabolism. The diverse metabolic landscape detected across IDEA participants shows that intervention type impacts the serum metabolome of individuals with OA in distinct patterns. Moreover, differences in the serum metabolome corresponded with participant sex. Conclusions: These findings suggest that intensive weight loss among male and female subjects offers potential metabolic benefits for individuals with knee OA. This provides a deeper understanding of dysregulation occurring during OA development that may pave the way for improved interventions, treatments, and quality of life of those impacted by this disease.

Collegiate Dancers With Chronic Ankle Instability Possess Altered Strength and saut de chat Leap Landing Mechanics.

INTRODUCTION: Ankle sprains are among the most common injuries in dancers. Following one or more severe sprains, some individuals will experience residual mechanical and functional deficits, otherwise known as chronic ankle instability (CAI). Dancers who suffer from CAI may have weaker musculature surrounding the ankle and altered landing mechanics. The purpose of this study was to compare ankle strength and saut de chat landing mechanics between dancers with and without CAI. METHODS: Dancers with and without CAI, defined by the Identification of Functional Ankle Instability (IdFAI), participated in the study (CAI n = 8; IdFAI = 18.75 ± 5.50 points; age = 20 ± 1.5 years; training = 15.5 ± 3.5 years) (Control n = 8; IdFAI = 7.13 ± 3.40 points; age = 19 ± 0.6 years; training = 15.9 ± 2.5 years). Strength and leap landing mechanics were measured on the affected ankle for the CAI group and on the preferred landing leg of a leap for the control group. Concentric and eccentric ankle plantar flexion, and subtalar inversion and eversion strength were determined with dynamometry set at an angular velocity of 60°â€¢s-1. Force plates and motion capture cameras were used to calculate lower extremity kinematic and kinetic data as participants performed 3 saut de chat leaps. Independent t-tests were calculated to determine differences between groups. RESULTS: Compared to dancers without CAI, dancers with CAI had lower eccentric plantar flexor strength, landed with higher vertical ground reaction forces, and absorbed greater power at the knee-joint during landing. CONCLUSION: Whether dancers who are weaker are more prone to injury or ankle-joint injury leads to muscular weakness is unknown. Dancers with CAI appear to lack control during leap landing while concomitantly shifting loads proximally away from the ankle-joint. We encourage dancers with and without CAI to engage in additional training that enhances ankle strength.

Clinical, Health-Related Quality of Life, and Gait Differences Among Obesity Classes in Adults With Knee Osteoarthritis.

OBJECTIVE: The purpose of this study was to determine whether clinical, health-related quality of life (HRQL), and gait characteristics in adults with knee osteoarthritis (OA) differed by obesity category. METHODS: This cross-sectional analysis of 823 older adults (mean age 64.6 years, SD 7.8 years) with knee OA and overweight or obesity compared clinical, HRQL, and gait outcomes among obesity classifications (overweight or class I, body mass index [BMI] 27.0-34.9; class II, BMI 35.0-39.9; class III BMI ≥40.0). RESULTS: Patients with class III obesity had worse Western Ontario McMasters Universities Arthritis Index knee pain (0-20) than the overweight or class I (mean 8.6 vs 7.0; difference 1.5; 95% confidence interval [CI] 1.0-2.1; P < 0.0001) and class II (mean 8.6 vs 7.4; difference 1.1; 95% CI 0.6-1.7; P = 0.0002) obesity groups. The Short Form 36 physical HRQL measure was lower in the class III obesity group compared to the overweight or class I (mean 31.0 vs 37.3; difference -6.2; 95% CI -7.8 to -4.7; P < 0.0001) and class II (mean 31.0 vs 35.0; difference -3.9; 95% CI -5.6 to -2.2; P < 0.0001) obesity groups. The class III obesity group had a base of support (cm) during gait that was wider than that for the overweight or class I (mean 14.0 vs 11.6; difference 3.3; 95% CI 2.6-4.0; P < 0.0001) and class II (mean 14.0 vs 11.6; difference 2.4; 95% CI 1.6-3.2; P < 0.0001) obesity groups. CONCLUSION: Among adults with knee OA, those with class III obesity had significantly higher pain levels and worse physical HRQL and gait characteristics compared to adults with overweight or class I or class II obesity.

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.

Walk with ease for knee osteoarthritis: A cost-effectiveness analysis.

Objective: The Walk With Ease (WWE) program was developed by the Arthritis Foundation to help people with arthritis learn to exercise safely and improve arthritis symptoms. We sought to establish the value of the WWE program. Methods: We used the Osteoarthritis Policy (OAPol) Model, a widely published and validated computer simulation of knee osteoarthritis (OA), to assess the cost-effectiveness of WWE in knee OA. We derived model inputs using data from a workplace wellness initiative in Montana that offered WWE to state employees. Our primary outcomes were quality-adjusted life years (QALYs) and costs over a 2-year period, which we used to calculate the incremental cost-effectiveness ratio (ICER). The base case analysis was restricted to subjects who were inactive or insufficiently active (<180 â€‹min/week of PA) at baseline. We performed scenario and probabilistic sensitivity analyses to determine the impact of uncertainty in model parameters on our results. Results: In the base case analysis, adding WWE to usual care resulted in an ICER of $47,900/QALY. When the program was offered without preselection by baseline activity level, the ICER for WWE â€‹+ â€‹usual care was estimated at $83,400/QALY. Results of the probabilistic sensitivity analysis indicated that WWE offered to inactive or insufficiently active individuals has a 52% chance of having an ICER <$50,000/QALY. Conclusion: The WWE program offers good value for inactive/insufficiently active individuals. Payers may consider including such a program to increase physical activity in individuals with knee OA.

Cost-Effectiveness of Surgical Weight-Loss Interventions for Patients With Knee Osteoarthritis and Class III Obesity.

OBJECTIVE: Class III obesity (body mass index [BMI] ≥40 kg/m2 ) is associated with worse knee pain and total knee replacement (TKR) outcomes. Because bariatric surgery yields sustainable weight loss for individuals with BMI ≥40 kg/m2 , our objective was to establish the value of Roux-en-Y gastric bypass (RYGB) and laparoscopic sleeve gastrectomy (LSG) in conjunction with usual care for knee osteoarthritis (OA) patients with BMI ≥40 kg/m2 . METHODS: We used the Osteoarthritis Policy model to assess long-term clinical benefits, costs, and cost-effectiveness of RYGB and LSG. We derived model inputs for efficacy, costs, and complications associated with these treatments from published data. Primary outcomes included quality-adjusted life-years (QALYs), lifetime costs, and incremental cost-effectiveness ratios (ICERs), all discounted at 3%/year. This analysis was conducted from a health care sector perspective. We performed sensitivity analyses to evaluate uncertainty in input parameters. RESULTS: The usual care + RYGB strategy increased the quality-adjusted life expectancy by 1.35 years and lifetime costs by $7,209, compared to usual care alone (ICER = $5,300/QALY). The usual care + LSG strategy yielded less benefit than usual care + RYGB and was dominated. Relative to usual care alone, both usual care + RYGB and usual care + LSG reduced opioid use from 13% to 4%, and increased TKR usage from 30% to 50% and 41%, respectively. For cohorts with BMI between 38 and 41 kg/m2 , usual care + LSG dominated usual care + RYGB. In the probabilistic sensitivity analysis, at a willingness-to-pay threshold of $50,000/QALY, usual care + RYGB and usual care + LSG were cost-effective in 70% and 30% of iterations, respectively. CONCLUSION: RYGB offers good value among knee OA patients with BMI ≥40 kg/m2 , while LSG may provide good value among those with BMI between 35 and 41 kg/m2 .

Cost-Effectiveness of Weight-Loss Interventions Prior to Total Knee Replacement for Patients With Class III Obesity.

OBJECTIVE: Class III obesity (body mass index >40 kg/m2 ) is associated with higher complications following total knee replacement (TKR), and weight loss is recommended. We aimed to establish the cost-effectiveness of Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastrectomy (LSG), and lifestyle nonsurgical weight loss (LNSWL) interventions in knee osteoarthritis patients with class III obesity considering TKR. METHODS: Using the Osteoarthritis Policy model and data from published literature to derive model inputs for RYGB, LSG, LNSWL, and TKR, we assessed the long-term clinical benefits, costs, and cost-effectiveness of weight-loss interventions for patients with class III obesity considering TKR. We assessed the following strategies with a health care sector perspective: 1) no weight loss/no TKR, 2) immediate TKR, 3) LNSWL, 4) LSG, and 5) RYGB. Each weight-loss strategy was followed by annual TKR reevaluation. Primary outcomes were cost, quality-adjusted life expectancy (QALE), and incremental cost-effectiveness ratios (ICERs), discounted at 3% per year. We conducted deterministic and probabilistic sensitivity analyses to examine the robustness of conclusions to input uncertainty. RESULTS: LSG increased QALE by 1.64 quality-adjusted life-years (QALYs) and lifetime medical costs by $17,347 compared to no intervention, leading to an ICER of $10,600/QALY. RYGB increased QALE by 0.22 and costs by $4,607 beyond LSG, resulting in an ICER of $20,500/QALY. Relative to immediate TKR, LSG and RYGB delayed and decreased TKR utilization. In the probabilistic sensitivity analysis, RYGB was cost-effective in 67% of iterations at a willingness-to-pay threshold of $50,000/QALY. CONCLUSION: For patients with class III obesity considering TKR, RYGB provides good value while immediate TKR without weight loss is not economically efficient.

Effect of Diet and Exercise on Knee Pain in Patients With Osteoarthritis and Overweight or Obesity: A Randomized Clinical Trial.

Importance: Some weight loss and exercise programs that have been successful in academic center-based trials have not been evaluated in community settings. Objective: To determine whether adaptation of a diet and exercise intervention to community settings resulted in a statistically significant reduction in pain, compared with an attention control group, at 18-month follow-up. Design, Setting, and Participants: Assessor-blinded randomized clinical trial conducted in community settings in urban and rural counties in North Carolina. Patients were men and women aged 50 years or older with knee osteoarthritis and overweight or obesity (body mass index ≥27). Enrollment (N = 823) occurred between May 2016 and August 2019, with follow-up ending in April 2021. Interventions: Patients were randomly assigned to either a diet and exercise intervention (n = 414) or an attention control (n = 409) group for 18 months. Main Outcomes and Measures: The primary outcome was the between-group difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee pain score (range, 0 [none] to 20 [severe]; minimum clinically important difference, 1.6) over 18 months, tested using a repeated-measures mixed linear model with adjustments for covariates. There were 7 secondary outcomes including body weight. Results: Among the 823 randomized patients (mean age, 64.6 years; 637 [77%] women), 658 (80%) completed the trial. At 18-month follow-up, the adjusted mean WOMAC pain score was 5.0 in the diet and exercise group (n = 329) compared with 5.5 in the attention control group (n = 316) (adjusted difference, -0.6; 95% CI, -1.0 to -0.1; P = .02). Of 7 secondary outcomes, 5 were significantly better in the intervention group compared with control. The mean change in unadjusted 18-month body weight for patients with available data was -7.7 kg (8%) in the diet and exercise group (n = 289) and -1.7 kg (2%) in the attention control group (n = 273) (mean difference, -6.0 kg; 95% CI, -7.3 kg to -4.7 kg). There were 169 serious adverse events; none were definitely related to the study. There were 729 adverse events; 32 (4%) were definitely related to the study, including 10 body injuries (9 in diet and exercise; 1 in attention control), 7 muscle strains (6 in diet and exercise; 1 in attention control), and 6 trip/fall events (all 6 in diet and exercise). Conclusions and Relevance: Among patients with knee osteoarthritis and overweight or obesity, diet and exercise compared with an attention control led to a statistically significant but small difference in knee pain over 18 months. The magnitude of the difference in pain between groups is of uncertain clinical importance. Trial Registration: ClinicalTrials.gov Identifier: NCT02577549.

Reduction of risk factors for ACL Re-injuries using an innovative biofeedback approach: A phase I randomized clinical trial.

OBJECTIVES: Determine the safety and initial efficacy of a novel biofeedback intervention to improve landing mechanics in patients following anterior cruciate ligament reconstruction (ACLR). METHODS: Forty patients post-ACLR (age: 16.9 ± 2.0 years) were randomly allocated to a biofeedback intervention or an attention control group. Patients in the biofeedback group completed 12 sessions over six-weeks that included bilateral unweighted squats with visual and tactile biofeedback. Patients in the control group completed a six-week educational program. Lower extremity mechanics were collected during a bilateral stop jump at baseline, six-weeks, and 12-weeks post-intervention. Linear mixed-effects models adjusted for sex and graft type determined the main effects of and interactions between group and time. RESULTS: No group by time interaction existed for peak knee extension moment symmetry. A group by time interaction existed for peak vertical ground reaction force symmetry (p = 0.012), where patients in the biofeedback group had greater improvements in symmetry between baseline and post-intervention that were not maintained through the retention assessments. CONCLUSION: This novel biofeedback program did not reduce risk factors for second ACL injuries. Future work could develop and test multidisciplinary interventions for reducing second ACL injury risk factors. CLINICALTRIALS: GOV IDENTIFIER: (NCT03273673).

Estimating heterogeneity of physical function treatment response to caloric restriction among older adults with obesity.

Clinical trials conventionally test aggregate mean differences and assume homogeneous variances across treatment groups. However, significant response heterogeneity may exist. The purpose of this study was to model treatment response variability using gait speed change among older adults participating in caloric restriction (CR) trials. Eight randomized controlled trials (RCTs) with five- or six-month assessments were pooled, including 749 participants randomized to CR and 594 participants randomized to non-CR (NoCR). Statistical models compared means and variances by CR assignment and exercise assignment or select subgroups, testing for treatment differences and interactions for mean changes and standard deviations. Continuous equivalents of dichotomized variables were also fit. Models used a Bayesian framework, and posterior estimates were presented as means and 95% Bayesian credible intervals (BCI). At baseline, participants were 67.7 (SD = 5.4) years, 69.8% female, and 79.2% white, with a BMI of 33.9 (4.4) kg/m2. CR participants reduced body mass [CR: -7.7 (5.8) kg vs. NoCR: -0.9 (3.5) kg] and increased gait speed [CR: +0.10 (0.16) m/s vs. NoCR: +0.07 (0.15) m/s] more than NoCR participants. There were no treatment differences in gait speed change standard deviations [CR-NoCR: -0.002 m/s (95% BCI: -0.013, 0.009)]. Significant mean interactions between CR and exercise assignment [0.037 m/s (95% BCI: 0.004, 0.070)], BMI [0.034 m/s (95% BCI: 0.003, 0.066)], and IL-6 [0.041 m/s (95% BCI: 0.009, 0.073)] were observed, while variance interactions were observed between CR and exercise assignment [-0.458 m/s (95% BCI: -0.783, -0.138)], age [-0.557 m/s (95% BCI: -0.900, -0.221)], and gait speed [-0.530 m/s (95% BCI: -1.018, -0.062)] subgroups. Caloric restriction plus exercise yielded the greatest gait speed benefit among older adults with obesity. High BMI and IL-6 subgroups also improved gait speed in response to CR. Results provide a novel statistical framework for identifying treatment heterogeneity in RCTs.

Effects of adding a diet intervention to exercise on hip osteoarthritis pain: protocol for the ECHO randomized controlled trial.

BACKGROUND: Hip osteoarthritis (OA) is a leading cause of musculoskeletal pain. Exercise is a core recommended treatment. Despite some clinical guidelines also recommending weight loss for hip OA, there is no evidence from randomised controlled trials (RCT) to substantiate these recommendations. This superiority, 2-group, parallel RCT will compare a combined diet and exercise program to an exercise only program, over 6 months. METHODS: One hundred people with symptomatic and radiographic hip OA will be recruited from the community. Following baseline assessment, participants will be randomly allocated to either, i) diet and exercise or; ii) exercise only. Participants in the diet and exercise group will have six consultations with a dietitian and five consultations with a physiotherapist via videoconferencing over 6 months. The exercise only group will have five consultations with a physiotherapist via videoconferencing over 6 months. The exercise program for both groups will include prescription of strengthening exercise and a physical activity plan, advice about OA management and additional educational resources. The diet intervention includes prescription of a ketogenic very low-calorie diet with meal replacements and educational resources to support weight loss and healthy eating. Primary outcome is self-reported hip pain via an 11-point numeric rating scale (0 = 'no pain' and 10 = 'worst pain possible') at 6 months. Secondary outcomes include self-reported body weight (at 0, 6 and 12 months) and body mass index (at 0, 6 and 12 months), visceral fat (measured using dual energy x-ray absorptiometry at 0 and 6 months), pain, physical function, quality of life (all measured using subscales of the Hip Osteoarthritis Outcome Scale at 0, 6 and 12 months), and change in pain and physical activity (measured using 7-point global rating of change Likert scale at 6 and 12 months). Additional measures include adherence, adverse events and cost-effectiveness. DISCUSSION: This study will determine whether a diet intervention in addition to exercise provides greater hip pain-relief, compared to exercise alone. Findings will assist clinicians in providing evidence-based advice regarding the effect of a dietary intervention on hip OA pain. TRIAL REGISTRATION: ClinicalTrials.gov . Identifier: NCT04825483 . Registered 31st March 2021.

Impact of COVID-19 Pandemic on Physical Activity, Pain, Mood, and Sleep in Adults with Knee Osteoarthritis.

Objective: To examine changes in physical activity, sleep, pain and mood in people with knee osteoarthritis (OA) during the ongoing COVID-19 pandemic by leveraging an ongoing randomized clinical trial (RCT). Methods: Participants enrolled in a 12-month parallel two-arm RCT (NCT03064139) interrupted by the COVID-19 pandemic wore an activity monitor (Fitbit Charge 3) and filled out custom weekly surveys rating knee pain, mood, and sleep as part of the study. Data from 30 weeks of the parent study were used for this analysis. Daily step count and sleep duration were extracted from activity monitor data, and participants self-reported knee pain, positive mood, and negative mood via surveys. Metrics were averaged within each participant and then across all participants for pre-pandemic, stay-at-home, and reopening periods, reflecting the phased re-opening in the state of Massachusetts. Results: Data from 28 participants showed small changes with inconclusive clinical significance during the stay-at-home and reopening periods compared to pre-pandemic for all outcomes. Summary statistics suggested substantial variability across participants with some participants showing persistent declines in physical activity during the observation period. Conclusion: Effects of the COVID-19 pandemic on physical activity, sleep, pain, and mood were variable across individuals with OA. Specific reasons for this variability could not be determined. Identifying factors that could affect individuals with knee OA who may exhibit reduced physical activity and/or worse symptoms during major lifestyle changes (such as the ongoing pandemic) is important for providing targeted healthcare services and management advice towards those that could benefit from it the most.

Predictors of Clinically Meaningful Gait Speed Response to Caloric Restriction Among Older Adults Participating in Weight Loss Interventions.

BACKGROUND: The purpose of this study was to examine whether select baseline characteristics influenced the likelihood of an overweight/obese, older adult experiencing a clinically meaningful gait speed response (±0.05 m/s) to caloric restriction (CR). METHODS: Individual level data from 1 188 older adults participating in 8, 5/6-month, weight loss interventions were pooled, with treatment arms collapsed into CR (n = 667) or no CR (NoCR; n = 521) categories. Exercise assignment was equally distributed across groups (CR: 65.3% vs NoCR: 65.4%) and did not interact with CR (p = .88). Poisson risk ratios (95% confidence interval [CI]) were used to examine whether CR assignment interacted with select baseline characteristic subgroups: age (≥65 years), sex (female/male), race (Black/White), body mass index (BMI; ≥35 kg/m2), comorbidity (diabetes, hypertension, cardiovascular disease) status (yes/no), gait speed (<1.0 m/s), or inflammatory burden (C-reactive protein ≥3 mg/L, interleukin-6 ≥2.5 pg/mL) to influence achievement of ±0.05 m/s fast-paced gait speed change. Main effects were also examined. RESULTS: The study sample (69.5% female, 80.1% White) was 67.6 ± 5.3 years old with a BMI of 33.8 ± 4.4 kg/m2. Average weight loss achieved in the CR versus NoCR group was -8.3 ± 5.9% versus -1.1 ± 3.8%; p < .01. No main effect of CR was observed on the likelihood of achieving a clinically meaningful gait speed improvement (risk ratio [RR]: 1.09 [95% CI: 0.93, 1.27]) or gait speed decrement (RR: 0.77 [95% CI: 0.57, 1.04]). Interaction effects were nonsignificant across all subgroups. CONCLUSION: The proportion of individuals experiencing a clinically meaningful gait speed change was similar for CR and NoCR conditions. This finding is consistent across several baseline subgroupings.