Meaningful Improvements In Physical Function Research Articles

Time to Achieve the Minimal Clinically Important Difference in Primary Total Hip Arthroplasty: Comparison of Anterior and Posterior Surgical Approaches

BackgroundControversy remains over outcomes between total hip arthroplasty approaches. This study aimed to compare the time to achieve the minimal clinically important difference (MCID) for the Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form (HOOS-PS) and the Patient-Reported Outcomes Measurement Information System (PROMIS) Global-Physical for patients who underwent anterior and posterior surgical approaches in primary total hip arthroplasty. MethodsPatients from 2018 to 2021 with preoperative and postoperative HOOS-PS or PROMIS Global-Physical questionnaires were grouped by approach. Demographic and MCID achievement rates were compared, and survival curves with and without interval-censoring were used to assess the time to achieve the MCID by approach. Log-rank and weighted log-rank tests were used to compare groups, and Weibull regression analyses were performed to assess potential covariates. ResultsA total of 2,725 patients (1,054 anterior and 1,671 posterior) were analyzed. There were no significant differences in median MCID achievement times for either the HOOS-PS (anterior: 5.9 months, 95% confidence interval [CI]: 4.6 to 6.4; posterior: 4.4 months, 95% CI: 4.1 to 5.1, P = .65) or the PROMIS Global-Physical (anterior: 4.2 months, 95% CI: 3.5 to 5.3; posterior: 3.5 months, 95% CI: 3.4 to 3.8, P = .08) between approaches. Interval-censoring revealed earlier times of achieving the MCID for both the HOOS-PS (anterior: 1.509 to 1.511 months; posterior: 1.7 to 2.3 months, P = .87) and the PROMIS Global-Physical (anterior: 3.0 to 3.1 weeks; posterior: 2.7 to 3.3 weeks, P = .18) for both surgical approaches. ConclusionsThe time to achieve the MCID did not differ by surgical approach. Most patients will achieve clinically meaningful improvements in physical function much earlier than previously believed. Level of EvidenceLevel III, Retrospective Comparative Study.

Understanding the Impact of Early Depressive Burden on Patient Perceptions of Outcomes Following Cervical Disc Replacement

To evaluate the effect of early depressive burden on PROMs in the setting of cervical disc replacement (CDR). Patients who had undergone primary elective CDR with recorded preoperative and 6-week postoperative 9-item Patient Health Questionnaire (PHQ-9) scores were identified. Early depressive burden was calculated via addition of the preoperative and 6-week PHQ-9 scores. Patients were divided into 2 cohorts, those with summative PHQ-9 scores beneath one-half standard deviation less than the mean (Lesser Burden; LB) and those with summative PHQ-9 scores above one-half standard deviation greater than the mean (Greater Burden; GB). Magnitude of improvement in PROMs (ΔPROM) was compared within and between cohorts at 6-weeks (ΔPROM-6W) and final follow-up (ΔPROM-FF). PROMs evaluated includedPROMIS-PF/NDI/VAS-Neck (VAS-N)/VAS-Arm (VAS-A)/PHQ-9. Fifty-five patients were included with 34 in the LB cohort. The LB cohort demonstrated improvements from the preoperative baseline in 6-week PROMIS-PF/NDI/VAS-N/VAS-A (P ≤ 0.012, all). The GB cohort demonstrated improvements from the preoperative baseline in 6-week NDI/VAS-N/VAS-A/PHQ-9 (P ≤ 0.038, all). The GB cohort demonstrated greater ΔPROM-6W and ΔPROM-FF in PHQ-9 (P ≤ 0.047, both). The LB cohort demonstrated a greater ΔPROM-FF in PROMIS-PF (P= 0.023). Patients with a greater depressive burden were more likely to experience greater magnitudes of improvements in PHQ-9 at both 6-week and final follow-up and experience clinically meaningful improvement in depressive symptoms. Patients with a lesser depressive burden were more likely to experience a greater magnitude of improvement in PROMIS-PF at final follow-up and experience clinically meaningful improvement in physical function.

Pexidartinib improves physical functioning and stiffness in patients with tenosynovial giant cell tumor: results from the ENLIVEN randomized clinical trial

Background and purpose — The ENLIVEN trial showed that, after 25 weeks, pexidartinib statistically significantly reduced tumor size more than placebo in patients with symptomatic, advanced tenosynovial giant cell tumor (TGCT) for whom surgery was not recommended. Here, we detail the effect of pexidartinib on patient-reported physical function and stiffness in ENLIVEN. Patients and methods — This was a planned analysis of patient-reported outcome data from ENLIVEN, a double-blinded, randomized phase 3 trial of adults with symptomatic, advanced TGCT treated with pexidartinib or placebo. Physical function was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS)-physical function (PF), and worst stiffness was assessed using a numerical rating scale (NRS). A mixed model for repeated measures was used to compare changes in PROMIS-PF and worst stiffness NRS scores from baseline to week 25 between treatment groups. Response rates for the PROMIS-PF and worst stiffness NRS at week 25 were calculated based on threshold estimates from reliable change index and anchor-based methods. Results — Between baseline and week 25, greater improvements in physical function and stiffness were experienced by patients receiving pexidartinib than patients receiving placebo (change in PROMIS-PF = 4.1 [95% confidence interval (CI) 1.8–6.3] vs. –0.9 [CI −3.0 to 1.2]; change in worst stiffness NRS = –2.5 [CI −3.0 to −1.9] vs. –0.3 [CI −0.9 to 0.3]). Patients receiving pexidartinib had higher response rates than patients receiving placebo for meaningful improvements in physical function and stiffness. Improvements were sustained after 50 weeks of pexidartinib treatment. Interpretation — Pexidartinib treatment provided sustained, meaningful improvements in physical function and stiffness for patients with symptomatic, advanced TGCT.

Stand When You Can: development and pilot testing of an intervention to reduce sedentary time in assisted living

BackgroundProlonged daily sedentary time is associated with increased risk of cardiometabolic diseases, impaired physical function, and mortality. Older adults are more sedentary than any other age group and those in assisted living residences accumulate more sedentary time as they often have little need to engage in light-intensity or standing activities such as cleaning or meal preparation. This “low movement” environment can hasten functional decline. Thus, the purpose of this study was to develop a multi-level intervention to reduce and interrupt sedentary time within assisted living residences and conduct a pilot study to determine if the intervention is feasible and if further testing is warranted.Methods“Stand When You Can” (SWYC) was developed using a Social Ecological framework based on a review of literature and consultation with residents and staff at assisted living residences. After development, a six-week pilot study was conducted in two different residences with 10 older adults (82.2 ± 8.7 years). Before and after the 6 weeks, ActivPAL™ inclinometers were used to measure daily movement behaviours and self-report questionnaires assessed time spent in different sedentary behaviours and quality of life. Physical function was assessed using the Short Physical Performance Battery. Paired sample t-tests examined pre-post differences for pooled data and individual sites. At the end of the pilot study, feedback on the intervention was gathered from both residents and staff to examine feasibility.ResultsThere was a trend towards a decrease in self-reported sitting time (142 min/day; p = 0.09), although device-measured sedentary time did not change significantly. Participants with lower physical function at baseline showed clinically meaningful improvements in physical function after the 6 weeks (p = 0.04, Cohen’s d = 0.89). There was no change in quality of life. Residents and staff reported that the intervention strategies were acceptable and practical.ConclusionThis study suggests that a multi-level intervention for reducing prolonged sedentary time is feasible for implementation at assisted living residences. The intervention could potentially help delay functional decline among older adults when they transition to a supportive living environment. Longer and larger trials to test the efficacy of SWYC are necessary.Trial registrationName of Clinical Trial Registry: clinicaltrials.govTrial Registration number: NCT04458896.Date of registration: July 8, 2020. (Retrospectively registered).

Clinically Meaningful Changes In Mobility After An Exercise Program For Older Adults

Aging is associated with a progressive decline in muscle strength and mass, eventually leading to reduced functional ability and disability. Regular physical activity can slow this inevitable decline and promote physical wellbeing, improve physical function and reduce risk of chronic diseases in older adults. However, meaningful improvements in physical function for individuals in response to a training stimulus are often missed when only group effects are considered. PURPOSE: to examine interindividual variation in changes in functional ability in response to a 10-week exercise intervention designed to improve physical function in older adults. METHODS: 97 older adults (age= 72.7 yrs+7.9); BMI=32.3+7.2) completed the 10-week Physical Activity for Seniors for Life (PALS) group exercise and lifestyle behavior change program. 6MW (distance covered in 6 minutes), and UGS (meters/second (m/s) to walk 6 m distance) were measured before and after the exercise program. RESULTS: There was a significant (p<.05) improvement in 6mw and UGS for the group (m=60.2 meters and 0.1045 m/s respectively). For 6mw, 27% did not improve more than 20 meters (>20 meters is small meaningful change), 23% improved between 20 and 50 meters, and 50% improved more than 50 meters (>50 meters is substantial meaningful change). For UGS 38% showed less than 0.05 m/s improvement (0.05 m/s is small meaningful change), 12% improved between 0.05 and 0.1 m/s, and 47% improved more than 0.1 m/s (0.1 m/s is substantial meaningful change). CONCLUSIONS: Consideration of individual variability is important in establishing the clinical meaningfulness of improvements in physical function in response to exercise programs designed for older adults.

The efficacy and safety of exercise in metastatic solid cancer: A meta-analysis of randomized control trials.

e23107 Background: The prevalence of people living with metastatic solid cancers is increasing. Such patients can experience cancer-related fatigue, decreased physical function (PF), and poor quality of life (QoL). Exercise has been shown to improve these symptoms in the curative setting, but there is uncertainty about the efficacy and safety of exercise in patients with metastatic cancer. Methods: Studies were identified from 3 prior systematic reviews and updated using a search of PubMed. Included studies were prospective randomized controlled trials of any moderate/high intensity aerobic exercise or resistance training intervention versus control in patients with metastatic solid cancers. The mean score and standard deviation (SD) for validated outcome measures (QoL, PF, and fatigue) were extracted for intervention and control groups at baseline and post-intervention. The effect of exercise was evaluated as the pooled change between baseline and post-intervention comparing exercise and control groups. Analysis was performed using the Mann Whitney test. Results: Of 21 trials which met inclusion criteria, 7 were excluded due to incomplete data. Among patients with mean baseline scores, exercise was not associated with significant change in fatigue, PF or QoL, although improvement was noted in 6-minute walk test (6-MWT) (14.7 vs 27.4 meters). QoL scores showed non-significant improvement (0.4 vs 4.9). In those with baseline scores 2SD below mean, exercise provided clinically meaningful improvement in PF using two different subscales (0.44 vs 8.5 and -1.0 vs 5.1) and avoidance of decline in 6-MWT (-29.75 vs -0.38m), although these did not meet statistical significance. There was a statistical improvement in sit-to-stand at the mean and 2 SD below the mean (2.5 vs 6.5, p = 0.029) for both groups. Only 5 papers reported adverse events in a standardized fashion in both groups. No differences in falls, fractures, or pain were reported. Conclusions: In patients with metastatic solid cancers, exercise interventions are associated with clinically meaningful improvements in PF, and statistically improved sit-to-stand scores. The effects are seen in patients with baseline score at the mean or lower.

Responder analysis of patient-reported outcomes measurement information system (PROMIS) physical function (PF) and worst stiffness among patients with tenosynovial giant cell tumors (TGCT) in the ENLIVEN study.

e18236 Background: The double-blind, randomized, placebo-controlled phase 3 ENLIVEN study in TGCT demonstrated a significant tumor response at week 25 by RECIST for pexidartinib (39% vs. 0% for placebo) and improvement in joint function and symptoms. The aim of this analysis was to identify a threshold score for responder definitions for PROMIS-PF scale and Worst Stiffness Numerical Rating Scale (WS-NRS) and compared responder rates for pexidartinib versus placebo. Methods: Anchor- and distribution-based estimates were calculated, and cumulative distribution function (CDF) plots were generated to derive responder definition threshold estimates. Anchor- and distribution-based results and CDFs were evaluated through triangulation, following FDA PRO Guidance, to determine a single responder definition threshold (i.e., meaningful change) for each instrument. The proportion of responders at Week 25 between treatments was compared with Fisher’s Exact Test (2-sided). Results: 120 patients were randomized to pexidartinib (n = 61) and placebo (n = 59) and assessed through 25 weeks of treatment. Anchor-based analysis showed one-level improvement on the patient global rating of PF item was associated with a mean change of 4.0 on PROMIS-PF. Distribution-based estimates (0.5 SD and 1 SEM) for PROMIS-PF were 2.8 and 2.5, respectively. For WS-NRS, a response of “A little improved” by patients on the perception of stiffness item was associated with a mean change of 1.1. The distribution-based estimates for the WS-NRS item were 0.9 and 0.5, respectively. This resulted in the following responder definition thresholds: ≥3 points for PROMIS-PF and ≥1 for WS-NRS improvement. A greater proportion of pexidartinib as compared to placebo patients were responders by PROMIS-PF (30% vs. 5%, p &lt; 0.001) and WS-NRS (39% vs. 19%, p = 0.02) at week 25, respectively. Conclusions: Triangulation yielded responder definitions of ≥3 points for PROMIS-PF and ≥1 for WS-NRS. With these definitions, a greater proportion of patients treated with pexidartinib compared to placebo had meaningful improvement in physical function and stiffness.

Home-Based Exercise Prehabilitation During Preoperative Treatment for Pancreatic Cancer Is Associated With Improvement in Physical Function and Quality of Life.

Purpose: To investigate relationships among physical activity, changes in physical function, and health-related quality of life (HRQOL) among patients with pancreatic adenocarcinoma enrolled in a home-based exercise prehabilitation program. Methods: Patients with resectable pancreatic adenocarcinoma receiving preoperative chemotherapy and/or chemoradiation were enrolled on this prospective, single-arm trial and were advised to perform ≥60 minutes each of moderate-intensity aerobic exercise and strengthening exercise weekly. Activity was measured via self-report and accelerometers, including moderate-to-vigorous physical activity (MVPA), light physical activity (LPA), and sedentary activity (SA). Physical function measures at baseline and restaging follow-up included 6-minute walk test (6MWT), 5 times sit-to-stand (5×STS), handgrip strength (HGS), 3-m walk for gait speed (GS), and the PROMIS Physical Function Short Form. HRQOL was measured via the FACT-Hep questionnaire. Results: Fifty participants with mean age 66 years (standard deviation = 8 years) were enrolled. The 6MWT, 5×STS, and GS significantly improved from baseline to restaging follow-up (P=.001, P=.049, and P=.009, respectively). Increases in self-reported aerobic exercise, weekly MVPA, and LPA were associated with improvement in 6MWT (β=.19, P=.048; β=.18, P=.03; and β=.08, P=.03, respectively) and self-reported physical functioning (β=.02, P=.03; β=.03, P=.005; and β=.01, P=.02, respectively). Increased weekly LPA was associated with increased HRQOL (β=.03, P=.02). Increased SA was associated with decreased HRQOL (β=-.02,P=.01). Conclusions: Patients with potentially resectable pancreatic cancer exhibit meaningful improvement in physical function with prehabilitation; physical activity was associated with improved physical function and HRQOL. These data highlight the importance of physical activity during treatment for pancreatic cancer.

Physical function computer adaptive test outcomes in diabetic lumbar spine surgical patients

BACKGROUND CONTEXTDiabetes is a highly prevalent comorbid condition among patients undergoing spine surgery. Several studies have used legacy patient-reported outcome measures to implicate diabetes as a predictor of increased disability, pain, and decreased physical function and quality of life following spine surgery. The effect of diabetes on postoperative physical function has not yet been studied using the PROMIS Physical Function Computer Adaptive Test (PF CAT). PURPOSETo understand the effect of diabetes on physical function outcomes among patients undergoing lumbar spine surgery, as reported by the PF CAT. STUDY DESIGN/SETTINGA retrospective cohort study was performed at a single university-based spine clinic. PATIENT SAMPLEPatients who underwent lumbar spine surgery between October 1, 2013 and April 26, 2018 with both PF CAT and Oswestry Disability Index (ODI) scores available for review. OUTCOME MEASURESPROMIS PF CAT. Secondary measures of disability included the ODI. METHODSPF CAT and ODI questionnaires were administered to patients via electronic tablets. Data from these questionnaires were collected prospectively, and retrieved from a university database. Wilcox tests, Exact Wilcox tests, linear regression models, and descriptive analytics were applied. RESULTSPatients meeting inclusion criteria included 233 nondiabetic patients and 65 diabetic patients. Mean PF CAT scores among diabetics were lower than those of nondiabetics at all time-points from preoperative through 12 months postoperative, with significance found at both 6 months (p=.035) and 12 months (p=.039) postoperative. Mean ODI scores among diabetics were significantly higher than those of nondiabetics at 3 months (p=.018) and 12 months (p=.027) postoperative. By 12 months postoperative, a smaller proportion of diabetics reached PF CAT and ODI minimum clinically important difference thresholds when compared to nondiabetics. CONCLUSIONSDiabetes is associated with lower PF CAT scores up to one year following lumbar spine surgery. However, many of these patients achieve meaningful improvement in physical function during this time. The PF CAT is consistent with legacy outcome measures in assessing outcomes in diabetic patients undergoing lumbar spine surgery, with an added benefit of decreased patient burden.

The Effect Of Two Low-dose Strength/Balance Programs On The Physical Function Of Mobility-limited Older Adults

BACKGROUND: Strength and balance training are critical to maintaining physical function and delaying the onset of major mobility disability in older adults (OAs). The minimum amount of this training required to yield clinically meaningful improvements in physical function is not clear. PURPOSE: To evaluate the effect of two low dose strength/balance programs on physical function in mobility-limited OAs. METHODS: Twenty community-dwelling OAs with mobility limitations were randomized to one of two strength/balance doses (n=10/dose), held 3x/week at a local YMCA for 10 wks. Eligible participants were ≥ 65 yrs of age, exhibited mild to moderate mobility impairment (short physical performance battery (SPPB) score of 3-9 out of 12), sedentary (<125 minutes/week of any kind of physical activity, determined by 7-day pre-baseline accelerometry), and had no major medical issues that would preclude exercise. Exercise doses were as follows: Low dose (L): 1 set each of chair stands, hip abduction, step-up and back with head turns, toe raises, and a balance stand). Higher dose (H): 2 sets of the previous mentioned exercises were performed. Each exercise had three variations of difficulty to accommodate different participant abilities and the number of reps were based on an RPE of 7 out of 10. Participants were assessed on SPPB score and 400m walk speed before and after the intervention by individuals blinded to which dose that participant was randomized to. Clinically meaningful improvements were defined as an SPPB improvement of 0.5 points and a 400m walk speed improvement of 0.05 m/sec. Data was analyzed using a t-paired test. Results are expressed as means (+ std deviation). RESULTS: SPPB score improved by 2.5 (+ 1.1) points among the entire cohort (p<0.001). Improvement was significant for each dose alone (L: 1.5 (+ 0.6), p<0.05), (H: 3.0 (+ 0.82), p<0.001). The improvement in SPPB score in the higher dose was significantly different from that observed with the lower dose (p<0.05). There was no significant effect of either dose on 400m walk speed. CONCLUSION: A 10 wk strength/balance program performed 3x/week and consisting of a single set each of select strength/balance exercises was sufficient to elicit clinically meaningful improvements in physical function for OAs with mild to moderate mobility limitations.

Effects of a Translational Community-Based Multimodal Exercise Program on Quality of Life and the Influence of Start Delay on Physical Function and Quality of Life in Breast Cancer Survivors: A Pilot Study.

The purpose of this investigation was 2-fold: (1) to investigate the effects of a translational 12-week community-based multimodal exercise program on quality of life (QoL) in breast cancer survivors (BCS) and (2) to examine the influence of a start delay on physical function and QoL in BCS. Fifty-two female BCS completed a 12-week program consisting of 90-minute supervised exercise sessions at a frequency of 2 supervised sessions per week. Exercise sessions consisted of three 30-minute components: (1) aerobic conditioning, (2) resistance exercise training, and (3) balance and flexibility training. Significant (P < .05) improvements in QoL were identified post-program completion. Cohort stratification comparison between the early start (<1 year since completion of oncologic treatment) and late start (>1 year since completion of oncologic treatment) revealed no significant (P > .05) differences between the early start and late start groups on improvements in physical function. Regarding the influence of start delay on QoL, the early start group showed significant (P < .05) improvement in emotional well-being. No other significant differences in improvement in QoL were detected between the early start and late start groups. Regardless of start delay, meaningful improvements in physical function and QoL were found after completing the community-based multimodal exercise program. Early participation in community-based exercise programming may benefit BCS’ emotional well-being compared to later participation.

Patients with poor baseline walking capacity are most likely to improve their functional status with multimodal prehabilitation

Evidence suggests that multimodal prehabilitation programs comprising interventions directed at physical activity, nutrition, and anxiety coping can improve functional recovery after colorectal cancer operations; however, such programs may be more clinically meaningful and cost-effective if targeted to specific subgroups. This study aimed to estimate the extent to which patients with poor baseline functional capacity improve their functional capacity. Data for 106 participants enrolled in a multimodal, prehabilitation program before colorectal operations were analyzed. Low baseline functional capacity was defined as a 6-minute walking test distance (6MWD) of less than 400m. Participants were categorized as higher fitness (6MWD≥400m, n=70) or lower fitness (6MWD <400m, n=36). Changes in 6MWD over the preoperative period, and 4weeks and 8weeks after the operation were compared between groups. Secondary outcomes included patient-reported physical activity and health status, postoperative complications, duration of hospital stay, and readmissions. Less-fit patients were then compared with subjects in the rehabilitation arm of the original studies who had a baseline 6MWD <400m. Participants with lower baseline fitness had greater improvements in functional walking capacity with prehabilitation compared to patients with higher fitness (+46.5 [standard deviation 53.8] m vs +22.6 [standard deviation 41.8] m, P=.012). At 4weeks postoperatively, patients with lower baseline fitness were more likely to be recovered to their baseline 6MWD than those with higher fitness. (74% vs 50%, P=.029). There were no differences in secondary outcome. Less-fit patients had a greater improvement through all the preoperative period compared to the control group. Patients with lower baseline walking capacity are more likely to experience meaningful improvement in physical function from prehabilitation before and after a colorectal cancer operation.

Efficacy and Safety of Subcutaneous Golimumab in Methotrexate-Naive Patients With Rheumatoid Arthritis: Five-Year Results of a Randomized Clinical Trial.

ObjectiveTo evaluate the safety and efficacy of golimumab through 5 years in adults with active rheumatoid arthritis (RA) who had not previously received methotrexate (MTX).MethodsIn the GO‐BEFORE study, 637 MTX‐naive adult patients with active RA were randomized (1:1:1:1) to placebo + MTX (group 1), golimumab 100 mg + placebo (group 2), golimumab 50 mg + MTX (group 3), or golimumab 100 mg + MTX (group 4). Inadequate responders in groups 1, 2, and 3 entered early escape at week 28 to golimumab 50 mg + MTX, golimumab 100 mg + MTX, or golimumab 100 mg + MTX, respectively; remaining patients in group 1 could cross over to golimumab 50 mg + MTX at week 52. Assessments included the American College of Rheumatology 20%/50%/70% improvement criteria (ACR20/50/70) response, the Disease Activity Score in 28 joints (DAS28) using C‐reactive protein (CRP) level, and the modified Sharp/van der Heijde score (SHS). Efficacy was analyzed using an intent‐to‐treat (ITT) analysis. Pharmacokinetics and immunogenicity were evaluated at selected visits.ResultsA total of 422 patients completed golimumab treatment through week 256. At week 256, 72.8%, 54.6%, and 38.0% of all patients in the full ITT population (n = 637) had an ACR20/50/70 response, respectively; 84.1% had a good or moderate DAS28‐CRP response; and 72.7% had a clinically meaningful improvement in physical function. Radiographic progression was minimal in all treatment groups through week 256, and the overall mean change from baseline in SHS was 1.36. Serum trough golimumab concentrations were approximately dose proportional and maintained through week 256. Antibodies to golimumab occurred in 9.6% of patients through week 256. Infections were the most common type of adverse event (AE); 204 of 616 patients (33.1%) had ≥1 serious AE.ConclusionClinical efficacy with golimumab treatment was maintained through week 256 of the GO‐BEFORE trial of MTX‐naive RA patients. No unexpected AEs occurred; safety results through 5 years are consistent with earlier reports.

SAT0382 Palace 4, A Phase 3, Randomized, Controlled TRIAL of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, for Treatment of Psoriatic Arthritis: Long-Term (52-WEEK) Improvements in Physical Function

BackgroundApremilast (APR), an oral phosphodiesterase 4 inhibitor, works intracellularly to regulate inflammatory mediators. PALACE 4 compared APR efficacy/safety with placebo (PBO) in patients (pts) with active PsA who were DMARD-naïve.ObjectivesEvaluate...

SAT0280 Efficacy of Apremilast, An Oral Phosphodiesterase 4 Inhibitor, on Physical Function and Pain in Patients with Psoriatic Arthritis, Including Current Skin Involvement: Results of a Phase 3, Randomized, Controlled Trial

BackgroundApremilast (APR), an oral phosphodiesterase 4 inhibitor, works intracellularly to modulate inflammatory mediators.ObjectivesPALACE 3 compared APR vs placebo (PBO) in patients with active psoriatic arthritis (PsA) and 1 or more...

OP0104 Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis Including Current Skin Involvement: Results of a Phase 3, Randomized, Controlled Trial

BackgroundApremilast (APR), an oral phosphodiesterase 4 inhibitor, works intracellularly to modulate inflammatory mediators.ObjectivesPALACE 3 compared APR vs placebo (PBO) in patients with active psoriatic arthritis (PsA) and at least 1...

AB0525 Local open-label multicenter study to evaluate the quality of life in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDS when adding tocilizumab

BackgroundRheumatoid Arthtritis (RA) is systemic autoimmune disease affecting 1% of the population. The disease process is characterized by persistent synovitis and progressive joint destruction leading to disability. In spite of...

Knee osteoarthritis patients undergoing a non-invasive biomechanical training program demonstrate alterations in sagittal plane knee kinetics: a prospective clinical study

reported function (KOS-ADLS) did not change in either group (P1⁄40.07). Symmetry in knee flexion excursion showed group by time interaction (P1⁄40.004) with absolute increase of 29% in the home-based group and no change in the clinic-based group. Symmetry in the knee external adduction and flexion moments showed no change in both groups (P>0.10). Symmetry in the first peak of the vertical ground reaction force showed a significant time effect (P1⁄40.04) with absolute increase of 1.4% and 2.6% in the clinic-based and the home-based groups respectively. Conclusions:In subjects who are considered fully recovered from TKA surgery, progressive strengthening exercises resulted in improvement in quadriceps strength symmetry, but this improvement in strength symmetry did not result in meaningful improvements in physical function or gait symmetry. Rehabilitation programs that focus on progressive strengthening of the operated limb muscles might not be enough to improve loading symmetry in patients after TKA.

Long‐term outcomes and costs of an integrated rehabilitation program for chronic knee pain: A pragmatic, cluster randomized, controlled trial

Chronic joint pain is a major cause of pain and disability. Exercise and self-management have short-term benefits, but few studies follow participants for more than 6 months. We investigated the long-term (up to 30 months) clinical and cost effectiveness of a rehabilitation program combining self-management and exercise: Enabling Self-Management and Coping of Arthritic Knee Pain Through Exercise (ESCAPE-knee pain). In this pragmatic, cluster randomized, controlled trial, 418 people with chronic knee pain (recruited from 54 primary care surgeries) were randomized to usual care (pragmatic control) or the ESCAPE-knee pain program. The primary outcome was physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] function), with a clinically meaningful improvement in physical function defined as a ≥15% change from baseline. Secondary outcomes included pain, psychosocial and physiologic variables, costs, and cost effectiveness. Compared to usual care, ESCAPE-knee pain participants had large initial improvements in function (mean difference in WOMAC function -5.5; 95% confidence interval [95% CI] -7.8, -3.2). These improvements declined over time, but 30 months after completing the program, ESCAPE-knee pain participants still had better physical function (difference in WOMAC function -2.8; 95% CI -5.3, -0.2); lower community-based health care costs (£-47; 95% CI £-94, £-7), medication costs (£-16; 95% CI £-29, £-3), and total health and social care costs (£-1,118; 95% CI £-2,566, £-221); and a high probability (80-100%) of being cost effective. Clinical and cost benefits of ESCAPE-knee pain were still evident 30 months after completing the program. ESCAPE-knee pain is a more effective and efficient model of care that could substantially improve the health, well-being, and independence of many people, while reducing health care costs.

Short-Term Changes In Pedometer-Determined Physical Activity In Knee Osteoarthritis Patients: Evidence From The IMPACT-P Trial

For older adults diagnosed with knee osteoarthritis (OA), physical activity (PA) is an efficacious adjuvant treatment approach that consistently results in meaningful improvements in physical function and quality of life. Despite the established benefits of PA, successfully promoting maintenance of regular PA participation remains a daunting challenge that frequently undermines the efficacy of interventions targeting knee OA patients. PURPOSE: The Improving Maintenance of Physical Activity - Pilot (IMPACT-P) is a single-blind, randomized controlled pilot trial designed to determine the comparable efficacy of traditional exercise training (TRAD) and a group-mediated cognitive behavioral exercise intervention (GMCB) in producing increased physical activity participation in older, knee OA patients. METHODS: Fifty-five knee OA patients (M age = 63 years) were randomly assigned to GMCB (n = 28) or TRAD (n = 27) interventions. Measurement of pedometer-determined PA was obtained at baseline and 3-month follow-up assessments. RESULTS: Results of an intention to treat analyses involving a 2 (Intervention) × 2 (Time) ANCOVA controlling for age yielded a significant Intervention × Time interaction (p < 0.01). Post hoc analyses revealed that pedometer-determined PA increased significantly from baseline in the GMCB intervention (d =.31) whereas a non-significant change (d = -.05) was observed following the TRAD intervention. CONCLUSIONS: The present findings demonstrate that the GMCB intervention produced superior short-term improvement in objectively-measured PA participation relative to a standardized approach to exercise training among older, knee OA patients. These results suggest that an exercise intervention designed to provide training and practice in activity-related behavioral self-regulatory skills may augment the short-term maintenance of PA participation beyond that observed with a traditional exercise training approach among older, knee OA patients. Accordingly, the differences in objectively-determined PA observed in IMPACT-P may have valuable implications for the design and delivery of future interventions targeting the promotion of PA participation in older, knee OA patients. Supported by NIH/NIAMS R21 AR054595