Stratified exercise therapy does not improve outcomes compared with usual exercise therapy in people with knee osteoarthritis (OCTOPuS study): a cluster randomised trial.

QUESTION: In people with knee osteoarthritis, how much more effective is stratified exercise therapy that distinguishes three subgroups (high muscle strength subgroup, low muscle strength subgroup, obesity subgroup) in reducing knee pain and improving physical function than usual exercise therapy? DESIGN: Pragmatic cluster randomised controlled trial in a primary care setting. PARTICIPANTS: A total of 335 people with knee osteoarthritis: 153 in an experimental arm and 182 in a control arm. INTERVENTION: Physiotherapy practices were randomised into an experimental arm providing stratified exercise therapy (supplemented by a dietary intervention from a dietician for the obesity subgroup) or a control arm providing usual, non-stratified exercise therapy. OUTCOME MEASURES: Primary outcomes were knee pain severity (numerical rating scale for pain, 0 to 10) and physical function (Knee Injury and Osteoarthritis Outcome Score subscale activities of daily living, 0 to 100). Measurements were performed at baseline, 3 months (primary endpoint) and 6 and 12 months (follow-up). Intention-to-treat, multilevel, regression analysis was performed. RESULTS: Negligible differences were found between the experimental and control groups in knee pain (mean adjusted difference 0.2, 95% CI -0.4 to 0.7) and physical function (-0.8, 95% CI -4.3 to 2.6) at 3 months. Similar effects between groups were also found for each subgroup separately, as well as at other time points and for nearly all secondary outcome measures. CONCLUSION: This pragmatic trial demonstrated no added value regarding clinical outcomes of the model of stratified exercise therapy compared with usual exercise therapy. This could be attributed to the experimental arm therapists facing difficulty in effectively applying the model (especially in the obesity subgroup) and to elements of stratified exercise therapy possibly being applied in the control arm. REGISTRATION: Netherlands National Trial Register NL7463.

Evaluation of an educational course for primary care physiotherapists on comorbidity-adapted exercise therapy in knee osteoarthritis: an observational study.

OBJECTIVE: The objectives of the present study were to: (1) evaluate the effect of an educational course on competence (knowledge and clinical reasoning) of primary care physical therapists (PTs) in treating patients with knee osteoarthritis (KOA) and comorbidity according to the developed strategy; and (2) identify facilitators and barriers for usage. METHOD: The present research was an observational study with a pretest-posttest design using mixed methods. PTs were offered a postgraduate course consisting of e-learning and two workshops (blended education) on the application of a strategy for exercise prescription in patients with KOA and comorbidity. Competences were measured by questionnaire on knowledge (administered before and 2 weeks after the course), and a patient vignette to measure clinical reasoning (administered before the course and after a 6 month period of treating patients). Facilitators and barriers for using the strategy were assessed by a questionnaire and semi-structured interviews. RESULTS: Thirty-four PTs were included. Competence (knowledge and clinical reasoning) improved significantly (p < 0.01). Fourteen out of 34 PTs had actually treated patients with KOA and comorbidity, during a 6-month period. The strategy was found to be feasible in daily practice. The main barriers included the limited number of (self-) referrals of patients, limited number of reimbursed treatment sessions by insurance companies and a suboptimal collaboration with (referring) physicians. CONCLUSION: A blended course on exercise therapy for patients with KOA and comorbidity seems to improve PTs' competence through increasing knowledge and clinical reasoning skills. Identified barriers should be solved before large-scale implementation of exercise therapy can take place in these complex patients.

Structured clinical reasoning for exercise prescription in patients with comorbidity.

Purpose: Exercise therapy is an effective intervention in a variety of chronic diseases. The prescription of exercise therapy is usually directed toward an index disease. The presence of comorbidity may require adaptations to the exercise program as intended for the index disease. This paper aims to structure the clinical reasoning process of health professionals when prescribing exercise therapy for the individual patient with an index disease and comorbidity.Methods: We adapted the previously published strategy for developing guidelines and protocols on comorbidity-adapted exercise to a version that can be used for individual exercise prescription.Results: Essential steps and considerations involved in prescribing an exercise program to an individual patient with comorbidity are described. A case description is used as an example of how the proposed strategy leads to clinical decisions.Conclusions: The proposed strategy may have a role in educational and professional development. The advanced clinical expertise needed for safe and effective exercise therapy in patients with a complex health status is emphasized.Implications for RehabilitationThe presence of comorbidity may require adaptations to exercise therapy.We describe the essential steps and considerations involved in prescribing an exercise program to an individual patient with an index disease and comorbidity.The proposed strategy can be used to structure the clinical reasoning process of health professionals.

Stratified exercise therapy compared with usual care by physical therapists in patients with knee osteoarthritis: A randomized controlled trial protocol (OCTOPuS study).

OBJECTIVES: Knee osteoarthritis (OA) is characterized by its heterogeneity, with large differences in clinical characteristics between patients. Therefore, a stratified approach to exercise therapy, whereby patients are allocated to homogeneous subgroups and receive a stratified, subgroup-specific intervention, can be expected to optimize current clinical effects. Recently, we developed and pilot tested a model of stratified exercise therapy based on clinically relevant subgroups of knee OA patients that we previously identified. Based on the promising results, it is timely to evaluate the (cost-)effectiveness of stratified exercise therapy compared with usual, "nonstratified" exercise therapy. METHODS: A pragmatic cluster randomized controlled trial including economic and process evaluation, comparing stratified exercise therapy with usual care by physical therapists (PTs) in primary care, in a total of 408 patients with clinically diagnosed knee OA. Eligible physical therapy practices are randomized in a 1:2 ratio to provide the experimental (in 204 patients) or control intervention (in 204 patients), respectively. The experimental intervention is a model of stratified exercise therapy consisting of (a) a stratification algorithm that allocates patients to a "high muscle strength subgroup," "low muscle strength subgroup," or "obesity subgroup" and (b) subgroup-specific, protocolized exercise therapy (with an additional dietary intervention from a dietician for the obesity subgroup only). The control intervention will be usual best practice by PTs (i.e., nonstratified exercise therapy). Our primary outcome measures are knee pain severity (Numeric Rating Scale) and physical functioning (Knee Injury and Osteoarthritis Outcome Score subscale daily living). Measurements will be performed at baseline, 3-month (primary endpoint), 6-month (questionnaires only), and 12-month follow-up, with an additional cost questionnaire at 9 months. Intention-to-treat, multilevel, regression analysis comparing stratified versus usual care will be performed. CONCLUSION: This study will demonstrate whether stratified care provided by primary care PTs is effective and cost-effective compared with usual best practice from PTs.

Tailoring exercise interventions to comorbidities and treatment-induced adverse effects in patients with early stage breast cancer undergoing chemotherapy: a framework to support clinical decisions.

PURPOSE: Delivery of exercise interventions to patients with early-stage breast cancer undergoing chemotherapy requires complex clinical decisions. The purpose of this study was to develop a framework to support clinical decisions for tailoring exercise interventions to common comorbidities and cancer treatment-induced adverse effects. METHOD: Tailored exercise prescriptions were developed in four steps, following the i3-S strategy. All steps were based on current best available evidence, complemented with expert opinions. First, common comorbidities and treatment-induced adverse effects were identified. In the subsequent steps, contra-indications and restrictions for exercise were described, along with possible exercise adaptations. In the final step, the obtained information was synthesized into a framework. RESULTS: Prevalent comorbidities were hypertension, heart disease, diabetes mellitus, (osteo)arthritis, chronic obstructive pulmonary disease, and obesity. Adverse effects included conditions induced by pretreatment (e.g., lymphedema as a result of surgery) or by chemotherapy (e.g., reduced blood cell counts). Adaptations to the recommended exercise program were related to exercise tolerance, safety, and hygiene. A framework was proposed to guide clinical decisions during the exercise intervention. CONCLUSION: Comorbidities and adverse effects of breast cancer treatment require exercise adaptations. The proposed framework provides guidance on tailored exercise prescriptions in patients with breast cancer undergoing chemotherapy. Implications for Rehabilitation Exercise is recommended for patients with breast cancer undergoing chemotherapy, but requires complex clinical decisions of the health professional. We identified the most important comorbidities and adverse effects of breast cancer treatment, and the resultant contra-indications and restrictions to exercise. We incorporated these findings into a clinical decision framework that provides suggestions for exercise adaptations in patients with breast cancer undergoing chemotherapy.

Subgrouping and TargetEd Exercise pRogrammes for knee and hip OsteoArthritis (STEER OA): a systematic review update and individual participant data meta-analysis protocol.

INTRODUCTION: Knee and hip osteoarthritis (OA) is a leading cause of disability worldwide. Therapeutic exercise is a recommended core treatment for people with knee and hip OA, however, the observed effect sizes for reducing pain and improving physical function are small to moderate. This may be due to insufficient targeting of exercise to subgroups of people who are most likely to respond and/or suboptimal content of exercise programmes. This study aims to identify: (1) subgroups of people with knee and hip OA that do/do not respond to therapeutic exercise and to different types of exercise and (2) mediators of the effect of therapeutic exercise for reducing pain and improving physical function. This will enable optimal targeting and refining the content of future exercise interventions. METHODS AND ANALYSIS: Systematic review and individual participant data meta-analyses. A previous comprehensive systematic review will be updated to identify randomised controlled trials that compare the effects of therapeutic exercise for people with knee and hip OA on pain and physical function to a non-exercise control. Lead authors of eligible trials will be invited to share individual participant data. Trial-level and participant-level characteristics (for baseline variables and outcomes) of included studies will be summarised. Meta-analyses will use a two-stage approach, where effect estimates are obtained for each trial and then synthesised using a random effects model (to account for heterogeneity). All analyses will be on an intention-to-treat principle and all summary meta-analysis estimates will be reported as standardised mean differences with 95% CI. ETHICS AND DISSEMINATION: Research ethical or governance approval is exempt as no new data are being collected and no identifiable participant information will be shared. Findings will be disseminated via national and international conferences, publication in peer-reviewed journals and summaries posted on websites accessed by the public and clinicians. PROSPERO REGISTRATION NUMBER: CRD42017054049.

Efficacy of Tailored Exercise Therapy on Physical Functioning in Patients With Knee Osteoarthritis and Comorbidity: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the efficacy on physical functioning and safety of tailored exercise therapy in patients with knee osteoarthritis (OA) and comorbidities. METHODS: In a randomized controlled trial, 126 participants were included with a clinical diagnosis of knee OA and at least 1 of the following target comorbidities: coronary disease, heart failure, type 2 diabetes mellitus, chronic obstructive pulmonary disease, or obesity (body mass index ≥30 kg/m2 ), with severity score ≥2 on the Cumulative Illness Rating Scale. The intervention group received a 20-week, individualized, comorbidity-adapted exercise program consisting of aerobic and strength training and training of daily activities. The control group received their current medical care for knee OA and were placed on a waiting list for exercise therapy. Primary outcome measures were the Western Ontario and McMaster Universities Osteoarthritis Index, subscale physical functioning (WOMAC-pf), and the 6-minute walk test (6MWT). Measurements were performed at baseline, after 20 weeks (directly posttreatment), and at 3 months posttreatment. RESULTS: Statistically significant physical functioning differences over time were found between the intervention and control group (WOMAC: B = -7.43 [95% confidence interval (95% CI) -9.99, -4.87], P < 0.001; and 6MWT: B = 34.16 [95% CI 17.68, 50.64], P < 0.001) in favor of the intervention group. At 3 months followup, the mean improvements in the intervention group were 33% on the WOMAC scale and 15% on the 6MWT. These improvements are of clinical relevance. No serious adverse events occurred during the intervention. CONCLUSION: This is the first study showing that tailored exercise therapy is efficacious in improving physical functioning and safe in patients with knee OA and severe comorbidities.

Course and predictors of pain and physical functioning in patients with hip osteoarthritis: Systematic review and meta-analysis.

OBJECTIVE: To systematically summarize the literature on: (i) the course of pain and physical functioning; and (ii) predictors of deterioration of pain and physical functioning in patients with osteoarthritis of the hip. METHODS: A literature search was conducted in PubMed, CINAHL, Embase, PsychINFO and SPORTDiscus up to July 2015. Meta-analyses and qualitative data syntheses were performed. RESULTS: Eleven of the 15 included studies were of high quality. With regard to the course of pain and physical functioning, high heterogeneity was found across studies (I² > 71%) and within study populations (reflected by large standard deviations (SDs) of change scores). Therefore, the course of pain and physical functioning was interpreted to be indistinct. Clinical characteristics (higher comorbidity count and presence of knee osteoarthritis), health behaviour factors (no supervised exercise and physical inactivity) and socio-demographics (lower education) were found to predict deterioration of pain (weak evidence). Higher comorbidity count and lower vitality were found to predict deterioration of physical functioning (strong evidence). For several other predictive factors weak evidence was found (e.g. bilateral hip pain, increase in hip pain (change), bilateral knee pain, presence of knee osteoarthritis). CONCLUSION: Because of high heterogeneity across studies and within study populations, no conclusions can be drawn with regard to the course of pain and physical functioning. Several clinical characteristics, health behaviours and psychosocial factors prognosticate deterioration of pain and physical functioning. These findings may guide future research aimed at the identification of subgroups of patients with hip osteoarthritis.

Prognosis of Pain and Physical Functioning in Patients With Knee Osteoarthritis: A Systematic Review and Meta-Analysis.

OBJECTIVE: To systematically summarize the literature on the course of pain in patients with knee osteoarthritis (OA), prognostic factors that predict deterioration of pain, the course of physical functioning, and prognostic factors that predict deterioration of physical functioning in persons with knee OA. METHODS: A search was conducted in PubMed, CINAHL, Embase, Psych-INFO, and SPORTDiscus up to January 2014. A meta-analysis and a qualitative data synthesis were performed. RESULTS: Of the 58 studies included, 39 were of high quality. High heterogeneity across studies (I(2) >90%) and within study populations (reflected by large SDs of change scores) was found. Therefore, the course of pain and physical functioning was interpreted to be indistinct. We found strong evidence for a number of prognostic factors predicting deterioration in pain (e.g., higher knee pain at baseline, bilateral knee symptoms, and depressive symptoms). We also found strong evidence for a number of prognostic factors predicting deterioration in physical functioning (e.g., worsening in radiographic OA, worsening of knee pain, lower knee extension muscle strength, lower walking speed, and higher comorbidity count). CONCLUSION: Because of high heterogeneity across studies and within study populations, no conclusions can be drawn with regard to the course of pain and physical functioning. These findings support current research efforts to define subgroups or phenotypes within knee OA populations. Strong evidence was found for knee characteristics, clinical factors, and psychosocial factors as prognostics of deterioration of pain and physical functioning.

Exercise and comorbidity: the i3-S strategy for developing comorbidity-related adaptations to exercise therapy.

PURPOSE: Exercise therapy is effective in a wide range of chronic diseases. Comorbid disease necessitates adaptations to exercise therapy. Guidance on how to develop such adaptations is currently not available. We present an innovative strategy for the development of comorbidity-related adaptations to exercise therapy in an index disease. METHOD: We previously developed comorbidity-related adaptations to exercise therapy in osteoarthritis. We now broaden this approach into a general strategy for the development of comorbidity-related adaptations to exercise therapy in an index disease. RESULTS: The i3-S strategy consists of four steps. The first three steps involve creating an inventory of comorbid disease, an inventory of contraindications and restrictions on exercise therapy, and an inventory of potential adaptations to exercise therapy. In the fourth step, this information is synthesized into guidance on comorbidity-related adaptations to exercise therapy in the index disease. The adaptations concern physiological, behavioural and environmental factors. CONCLUSION: In view of the general effectiveness of exercise therapy and the high prevalence of comorbidity in older people, there is a great need for comorbidity-related adaptations to exercise therapy. We recommend to use and evaluate the i3-S strategy in future research. IMPLICATIONS FOR REHABILITATION: Exercise therapy is effective in a wide range of chronic diseases. Comorbid disease necessitates adaptations to exercise therapy. Guidance on how to develop such adaptations is currently not available. We present an innovative strategy for the development of comorbidity-related adaptations to exercise therapy in an index disease. Researchers and clinicians can use this strategy to develop guidance on the adaptation of exercise therapy to comorbidity.

Knee joint stabilization therapy in patients with osteoarthritis of the knee and knee instability: subgroup analyses in a randomized, controlled trial.

OBJECTIVE: To test whether knee stabilization therapy, prior to strength/functional training, may have added value in reducing activity limitations only in patients with knee osteoarthritis who have knee instability and (i) low upper leg muscle strength, (ii) impaired knee proprioception, (iii) high knee laxity, or (iv) frequent episodes of knee instability. DESIGN: Subgroup analyses in a randomized controlled trial comparing 2 exercise programmes (with/without knee stabilization therapy) (STABILITY; NTR1475). PATIENTS: Participants from the STABILITY-trial with clinical knee osteoarthritis and knee instability (n = 159). METHODS: Effect modification by upper leg muscle strength, knee proprioception, knee laxity, and patient-reported knee instability were determined using the interaction terms "treatment group subgroup factor", with the outcome measures WOMAC physical function (primary), numeric rating scale pain and the Get up and Go test (secondary). RESULTS: Effect modification by muscle strength was found for the primary outcome (p = 0.01), indicating that patients with greater muscle strength tend to benefit more from the experimental programme with additional knee stabilization training, while patients with lower muscle strength benefit more from the control programme. CONCLUSION: Knee stabilization therapy may have added value in patients with instability and strong muscles. Thus it may be beneficial if exercises target muscle strength prior to knee stabilization.

Development of comorbidity-adapted exercise protocols for patients with knee osteoarthritis.

BACKGROUND: Exercise therapy is generally recommended for patients with osteoarthritis (OA) of the knee. Comorbidity, which is highly prevalent in OA, may interfere with exercise therapy. To date, there is no evidence-based protocol for the treatment of patients with knee OA and comorbidity. Special protocols adapted to the comorbidity may facilitate the application of exercise therapy in patients with knee OA and one or more comorbidities. PURPOSE: The purpose of this study was to develop comorbidity-adapted exercise protocols for patients with knee OA and comorbidity. METHOD: Several steps were undertaken to develop comorbidity-adapted protocols: selection of highly prevalent comorbidities in OA, a literature search to identify restrictions and contraindications for exercise therapy for the various comorbid diseases, consultation of experts on each comorbid disease, and field testing of the protocol in eleven patients with knee OA and comorbidity. RESULTS: Based on literature and expert opinion, comorbidity-adapted protocols were developed for highly prevalent comorbidities in OA. Field testing showed that the protocols provided guidance in clinical decision making in both the diagnostic and the treatment phase. Because of overlap, the number of exercise protocols could be reduced to three: one for physiological adaptations (coronary disease, heart failure, hypertension, diabetes type 2, chronic obstructive pulmonary diseases, obesity), one for behavioral adaptations (chronic a-specific pain, nonspecific low back pain, depression), and one for environmental adaptations (visual or hearing impairments). Evaluation of patient outcome after treatment showed significant (P<0.05) and clinically relevant improvements in activity limitations and pain. CONCLUSION: Comorbidity-adapted exercise protocols for patients with knee OA were developed, providing guidance in clinical reasoning with regard to diagnostics and treatment. To evaluate the effectiveness of treatment in line with our protocols, a randomized clinical trial should be performed.

Osteoarthritis of the hip or knee: which coexisting disorders are disabling?

Exercise therapy is generally recommended in osteoarthritis (OA) of the hip or knee. However, coexisting disorders may bring additional impairments, which may necessitate adaptations to exercise for OA of the hip or knee. For the purpose of developing an adapted protocol for exercise therapy in OA patients with coexisting disorders, information is needed on which specific coexisting disorders in OA are associated with activity limitations and pain. To describe the relationship between specific coexisting disorders, activity limitations, and pain in patients with OA of the hip or knee, a cross-sectional cohort study among 288 older adults (50-85 years of age) with OA of hip or knee was conducted. Subjects were recruited from three rehabilitation centers and two hospitals. Demographic data, clinical data, information about coexisting disorders (i.e., comorbidity and other disorders), activity limitations (WOMAC: physical functioning domain), and pain (visual analogue scale (VAS)) were collected by questionnaire. Statistical analysis included descriptive statistics and multivariate regression analysis. Coexisting disorders associated with activity limitations were chronic back pain or hernia, arthritis of the hand or feet, and other chronic rheumatic diseases (all musculoskeletal disorders); diabetes and chronic cystitis (non-musculoskeletal disorders); hearing impairments in a face-to-face conversation, vision impairments in long distances, and dizziness in combination with falling (all sensory impairments); and overweight and obesity. Coexistent disorders associated with pain were arthritis of the hand or feet, other chronic rheumatic diseases (musculoskeletal disorders), and diabetes (non-musculoskeletal disorder). Specific disorders coexisting next to OA and associated with additional activity limitations and pain were identified. These coexisting disorders need to be addressed in exercise therapy and rehabilitation for patients with OA of the hip or knee.