Activity pacing for osteoarthritis symptom management: study design and methodology of a randomized trial testing a tailored clinical approach using accelerometers for veterans and non-veterans.
ABSTRACT: Osteoarthritis (OA) is a prevalent chronic disease and a leading cause of disability in adults. For people with knee and hip OA, symptoms (e.g., pain and fatigue) can interfere with mobility and physical activity. Whereas symptom management is a cornerstone of treatment for knee and hip OA, limited evidence exists for behavioral interventions delivered by rehabilitation professionals within the context of clinical care that address how symptoms affect participation in daily activities. Activity pacing, a strategy in which people learn to preplan rest breaks to avoid symptom exacerbations, has been effective as part of multi-component interventions, but hasn't been tested as a stand-alone intervention in OA or as a tailored treatment using accelerometers. In a pilot study, we found that participants who underwent a tailored activity pacing intervention had reduced fatigue interference with daily activities. We are now conducting a full-scale trial.This paper provides a description of our methods and rationale for a trial that evaluates a tailored activity pacing intervention led by occupational therapists for adults with knee and hip OA. The intervention uses a wrist accelerometer worn during the baseline home monitoring period to glean recent symptom and physical activity patterns and to tailor activity pacing instruction based on how symptoms relate to physical activity. At 10 weeks and 6 months post baseline, we will examine the effectiveness of a tailored activity pacing intervention on fatigue, pain, and physical function compared to general activity pacing and usual care groups. We will also evaluate the effect of tailored activity pacing on physical activity (PA).Managing OA symptoms during daily life activity performance can be challenging to people with knee and hip OA, yet few clinical interventions address this issue. The activity pacing intervention tested in this trial is designed to help people modulate their activity levels and reduce symptom flares caused by too much or too little activity. As a result of this trial, we will be able to determine if activity pacing is more effective than usual care, and among the intervention groups, if an individually tailored approach improves fatigue and pain more than a general activity pacing approach.ClinicalTrials.gov: NCT01192516.
Project description:Osteoarthritis (OA) of the lower extremities is a prevalent cause of disability in which symptoms interfere with mobility and activity participation. Behavioral self-management for OA symptomatology is commonly recommended; but these interventions are underutilized, unstandardized in application, and at times, unavailable in the context of clinical care. For people with chronic pain, rehabilitation professionals may select to apply activity pacing instruction as one behavioral strategy to manage symptoms. Activity pacing is widely used in combination with other pharmacological and behavioral interventions but has not been studied as a singular behavioral intervention for people with OA. The purpose of this study was to evaluate the effectiveness of an occupational therapist-delivered, time-based activity pacing program for treatment of pain, fatigue, and physical function in people with symptomatic knee or hip OA. A 3-arm randomized controlled trial was conducted in which 193 people were randomized into tailored activity pacing, general activity pacing, or usual care arms. Assessments were done at 10 weeks and 6 months after baseline. Using linear mixed models, Western Ontario and McMaster Universities Osteoarthritis Index pain scores changed over time, decreasing the most in the general and usual care groups; only the usual care group had decreased pain over 6 months. The tailored and general activity pacing groups reported higher frequency of pacing behaviors than the usual care group at 10 weeks, but pacing was not sustained at 6 months. This trial does not support the use of time-based pacing as a singular behavioral strategy for people with knee or hip OA.
Project description:Integrating physical therapy sessions and an online application (e-Exercise) might support people with hip osteoarthritis (OA), knee OA, or both (hip/knee OA) in taking an active role in the management of their chronic condition and may reduce the number of physical therapy sessions.The objective of this study was to investigate the short- and long-term effectiveness of e-Exercise compared to usual physical therapy in people with hip/knee OA.The design was a prospective, single-blind, multicenter, superiority, cluster- randomized controlled trial.The setting included 143 primary care physical therapist practices.The participants were 208 people who had hip/knee OA and were 40 to 80 years of age.e-Exercise is a 3-month intervention in which about 5 face-to-face physical therapy sessions were integrated with an online application consisting of graded activity, exercise, and information modules. Usual physical therapy was conducted according to the Dutch physical therapy guidelines on hip and knee OA.Primary outcomes, measured at baseline after 3 and 12 months, were physical functioning and free-living physical activity. Secondary outcome measures were pain, tiredness, quality of life, self-efficacy, and the number of physical therapy sessions.The e-Exercise group (n = 109) received, on average, 5 face-to-face sessions; the usual physical therapy group (n = 99) received 12. No significant differences in primary outcomes between the e-Exercise group and the usual physical therapy group were found. Within-group analyses for both groups showed a significant improvement in physical functioning. After 3 months, participants in the e-Exercise group reported an increase in physical activity; however, no objectively measured differences in physical activity were found. With respect to secondary outcomes, after 12 months, sedentary behavior significantly increased in the e-Exercise group compared with the usual physical therapy group. In both groups, there were significant improvements for pain, tiredness, quality of life, and self-efficacy.The response rate at 12 months was 65%.The blended intervention, e-Exercise, was not more effective than usual physical therapy in people with hip/knee OA.
Project description:<h4>Background</h4>Osteoarthritis (OA) of the hip and knee are among the most common chronic conditions, resulting in substantial pain and functional limitations. Adequate management of OA requires a combination of medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and the majority of patients with hip and knee OA are overweight and physically inactive. Consequently, interventions at the provider-level and patient-level both have potential for improving outcomes. This manuscript describes two ongoing randomized clinical trials being conducted in two different health care systems, examining patient-based and provider-based interventions for managing hip and knee OA in primary care.<h4>Methods / design</h4>One study is being conducted within the Department of Veterans Affairs (VA) health care system and will compare a Combined Patient and Provider intervention relative to usual care among n?=?300 patients (10 from each of 30 primary care providers). Another study is being conducted within the Duke Primary Care Research Consortium and will compare Patient Only, Provider Only, and Combined (Patient + Provider) interventions relative to usual care among n?=?560 patients across 10 clinics. Participants in these studies have clinical and / or radiographic evidence of hip or knee osteoarthritis, are overweight, and do not meet current physical activity guidelines. The 12-month, telephone-based patient intervention focuses on physical activity, weight management, and cognitive behavioral pain management. The provider intervention involves provision of patient-specific recommendations for care (e.g., referral to physical therapy, knee brace, joint injection), based on evidence-based guidelines. Outcomes are collected at baseline, 6-months, and 12-months. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function), and secondary outcomes are the Short Physical Performance Test Protocol (objective physical function) and the Patient Health Questionnaire-8 (depressive symptoms). Cost effectiveness of the interventions will also be assessed.<h4>Discussion</h4>Results of these two studies will further our understanding of the most effective strategies for improving hip and knee OA outcomes in primary care settings.<h4>Trial registration</h4>NCT01130740 (VA); NCT 01435109 (NIH).
Project description:BACKGROUND:Individuals with knee and hip osteoarthritis (OA) are less physically active than people in general, and many of these individuals have adopted a sedentary lifestyle. In this study we evaluate the outcome of education and supervised exercise on the level of physical activity in individuals with knee or hip OA. We also evaluate the effect on pain, quality of life and self-efficacy. METHODS:Of the 264 included individuals with knee or hip OA, 195 were allocated to the intervention group. The intervention group received education and supervised exercise that comprised information delivered by a physiotherapist and individually adapted exercises. The reference group consisted of 69 individuals with knee or hip OA awaiting joint replacement and receiving standard care. The primary outcome was physical activity (as measured with an accelerometer). The secondary outcomes were pain (Visual Analog Scale), quality of life (EQ-5D), and self-efficacy (Arthritis Self-Efficacy Scale, pain and other symptoms subscales). Participants in both groups were evaluated at baseline and after 3 months. The intervention group was also evaluated after 12 months. RESULTS:No differences were found in the number of minutes spent in sedentary or in physical activity between the intervention and reference groups when comparing the baseline and 3 month follow-up. However, there was a significant difference in mean change (mean diff; 95% CI; significance) between the intervention group and reference group favoring the intervention group with regard to pain (13; 7 to 19; p?<?0.001), quality of life (-?0.17; -?0.24 to -?0.10; p?<?0.001), self-efficacy/other symptoms (-?5; -?10 to -?0.3; p?<?0.04), and self-efficacy/pain (-?7; -?13 to -?2; p?<?0.01). Improvements in pain and quality of life in the intervention group persisted at the 12-month follow-up. CONCLUSIONS:Participation in an education and exercise program following the Swedish BOA program neither decreased the average amount of sedentary time nor increased the level of physical activity. However, participation in such a program resulted in decreased pain, increased quality of life, and increased self-efficacy. TRIAL REGISTRATION:The trial is registered with ClinicalTrials.gov. Registration number: NCT02022566 . Retrospectively registered 12/18/2013.
Project description:To assess the pain and functional disability levels corresponding to an indication for total joint replacement (TJR) in hip and knee osteoarthritis (OA).International cross-sectional study in 10 countries.Consecutive outpatients with definite hip or knee OA attending an orthopaedic outpatient clinic. Gold standard measure for recommendation for TJR: Surgeon's decision that TJR is justified.Pain (ICOAP: intermittent and constant osteoarthritis pain, 0-100) and functional impairment (HOOS-PS/KOOS-PS: Hip/Knee injury and Osteoarthritis Outcome Score Physical function Short-form, 0-100).Comparison of patients with vs without surgeons' indication for TJR. Receiver Operating Characteristic (ROC) curve analyses and logistic regression were applied to determine cut points of pain and disability defining recommendation for TJR.In all, 1909 patients were included (1130 knee/779 hip OA). Mean age was 66.4 [standard deviation (SD) 10.9] years, 58.1% were women; 628/1130 (55.6%) knee OA and 574/779 (73.7%) hip OA patients were recommended for TJR. Although patients recommended for TJR (yes vs no) had worse symptom levels [pain, 55.5 (95% confidence interval 54.2, 56.8) vs. 44.9 (43.2, 46.6), and functional impairment, 59.8 (58.7, 60.9) vs. 50.9 (49.3, 52.4), respectively, both P<0.0001], there was substantial overlap in symptom levels between groups, even when adjusting for radiographic joint status. Thus, it was not possible to determine cut points for pain and function defining 'requirement for TJR'.Although symptom levels were higher in patients recommended for TJR, pain and functional disability alone did not discriminate between those who were and were not considered to need TJR by the orthopaedic surgeon.
Project description:INTRODUCTION:Current guidelines recommend tailored interventions to optimise knee osteoarthritis (OA) management. However, models of care still have a 'one size fits all' approach, which is suboptimal as it ignores patient heterogeneity. This study aims to compare a stepped care strategy with standard care for overweight and obese persons with medial tibiofemoral OA. METHODS AND ANALYSIS:Participants will be randomised into two groups (85 each). The intervention will receive a diet and exercise programme for 18 weeks in the first step of the study. Disease remission will then be assessed using the Patient Acceptable Symptom State (PASS). PASS is defined as the highest level of symptom beyond which patients consider themselves well and takes into account pain intensity, patient's global assessment of disease activity and degree of functional impairment. In the second step, participants in remission will continue with diet and exercise. If remission is not achieved, participants will be assigned in a hierarchical order to cognitive behavioural therapy, knee brace or muscle strengthening for 12 weeks. The intervention will be decided based on their clinical presentation for symptoms of depression and varus malalignment. Participants without depression or varus malalignment will undertake a muscle strengthening programme. The control group will receive educational material related to OA management. Main inclusion criteria are age ?50 years, radiographic medial tibiofemoral OA, body mass index (BMI) ?28?kg/m2, knee pain ?40 (Visual Analogue Scale, 0-100), PASS (0-100) >32 for pain and global assessment, and 31 for functional impairment. Outcomes will be measured at 20-week and 32-week visits. The primary outcome is disease remission at 32 weeks. Other outcomes include functional mobility; patient-reported outcomes; BMI; waist-hip ratio; quadriceps strength; symptoms of depression, anxiety and stress; and knee range of motion. The analysis will be performed according to the intention-to-treat principle. ETHICS AND DISSEMINATION:The local ethics committee approved this protocol (HREC/14/HAWKE/381). Dissemination will occur through presentations at international conferences and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER:ACTRN12615000227594.
Project description:Purpose: To determine the face and content validity, construct validity, and test-retest reliability of the OA Go Away (OGA), a personalized self-management tool to promote adherence to exercise and physical activity for people with osteoarthritis (OA) of the hip or knee. Methods: The face and content validity of OGA version 1.0 were determined via interviews with 10 people with OA of the hip or knee and 10 clinicians. A revised OGA version 2.0 was then tested for construct validity and test-retest reliability with a new sample of 50 people with OA of the hip or knee by comparing key items in the OGA journal with validated outcome measures assessing similar health outcomes and comparing scores on key items of the journal 4-7 days apart. Face and content validity were then confirmed with a new sample of 5 people with OA of the hip or knee and 5 clinicians. Results: Eighteen of 30 items from the OGA version 1.0 and 41 of 43 items from the OGA version 2.0 journal, goals and action plan, and exercise log had adequate content validity. Construct validity and test-retest reliability were acceptable for the main items of the OGA version 2.0 journal. The OGA underwent modifications based on results and participant feedback. Conclusion: The OGA is a novel self-management intervention and assessment tool for people with OA of the hip or knee that shows adequate preliminary measurement properties.
Project description:PURPOSE:The purpose of this study was to evaluate pain, functional impairment, mental health, and daily activity in patients with end-stage hip and knee osteoarthritis (OA) during the COVID-19 lockdown. METHODS:The study included 63 patients, with hip or knee OA, who had been scheduled for arthroplasty that was postponed because of COVID-19. Patients were evaluated by telephone interviews during the first week after lockdown, in the fourth week, and again at the end of the lockdown. Patients rated their pain level on the basis of a visual analog scale (VAS) and completed WOMAC, SF-12 and Tegner activity scale (TAS) questionnaires. RESULTS:VAS and WOMAC scores increased significantly during lockdown, while physical activity significantly decreased. At the final evaluation, VAS and WOMAC showed a significant negative correlation with TAS. The SF-12 subscale scores showed a significant decrease of the physical component during the lockdown, while the mental component remained largely unchanged. Patients with knee OA showed a faster progress of pain compared to those with hip OA. 50 patients (79%) stated they wished to have arthroplasty as soon as possible. CONCLUSION:The COVID-19 lockdown had a significant impact on pain, joint function, physical function, and physical activity in patients with end-stage hip and knee OA. LEVEL OF EVIDENCE:II (Prospective cohort study).
Project description:The aim of this study was to characterise the genome-wide DNA methylation profile of osteoathritis (OA) chondrocytes from both knee and hip cartilage, providing the first comparison of DNA methylation between OA and non-OA hip cartilage, and between OA hip and OA knee cartilage. The study was performed using the Illumina Infinium HumanMethylation450 BeadChip array. Genome-wide methylation was assesed in chondrocyte DNA extracted from 23 OA hip, 73 OA knee and 21 healthy hip controls (NOF - neck of femure samples). Keywords: Methylation profiling by array Overall design: Bisulphite converted DNA from the 97 samples were hybridised to the Illumina Infinium HumanMethylation450 BeadChip array.
Project description:OBJECTIVE:The objective of this study was to assess the clinical significance of increased fluorine-18-fluorodeoxyglucose (F-FDG) uptake on PET/CT in joints for evaluation of symptomatic osteoarthritis (OA) and prediction of progression. PATIENTS AND METHODS:In this prospective study, shoulder, hip, and knee joints were imaged in 65 patients undergoing routine F-FDG PET/CT imaging. Patients completed the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire to assess joint pain, stiffness, and physical function. Standardized uptake values (SUVs) were measured in hip, knee, acromioclavicular (AC), and glenohumeral (GH) joints. Scout PET/CT images were evaluated for OA using the Kellgren and Lawrence (K/L) system. Patients were followed-up for 5 years to determine the progression of OA on the basis of follow-up imaging or surgical intervention. RESULTS:SUV of knee (r=0.309, P=0.0003), hip (r=0.260, P=0.0027), AC (r=0.186, P=0.0313), and GH (r=0.191, P=0.0271) joints correlated with WOMAC overall scores. Furthermore, SUV of knee (r=0.410, P<0.0001), hip (r=0.203, P=0.0199), and AC (r=0.364, P<0.0001) joints correlated with K/L scores. The area under the receiver operating characteristic curves for SUV were 0.734 (knee), 0.678 (hip), 0.661 (AC), and 0.544 (GH) for symptomatic OA detection based on WOMAC overall z-score greater or equal to 2. Compared with K/L score [hazard ratio (HR)=0.798, P=0.5324], age (HR=0.992, P=0.8978), and WOMAC overall score (HR=1.089, P=0.1265), only SUV (HR=5.653, P=0.0229) was an independent predictor of OA progression in the knees. CONCLUSION:F-FDG PET/CT may be helpful with localization of painful abnormalities in the inflamed regions of the joints, which could potentially be used to direct individualized treatment in moderate and severe OA. Furthermore, SUV measurement on F-FDG PET/CT could serve as an inflammation activity index in the knees that may be predictive of outcomes and progression rate of OA.