A self-directed digital exercise program for hip osteoarthritis ("My Hip Exercise"): protocol for a randomised controlled trial.

BACKGROUND: Hip osteoarthritis (OA) is a leading global cause of chronic pain and disability. Given there is no cure for OA, patient self management is vital with education and exercise being core recommended treatments. However, there is under-utilisation of these treatments due to a range of clinician and patient factors. Innovative service models that increase patient accessibility to such treatments and provide support to engage are needed. This study primarily aims to determine the effects of a self-directed digital exercise intervention comprising online education and exercise supported by a mobile app to facilitate adherence on the primary outcomes of changes in hip pain during walking and patient-reported physical function at 24-weeks when compared to online education control for people with hip OA. METHODS: We will conduct a two-arm, superiority parallel-design, randomised controlled trial involving 182 community volunteers aged 45 years and over, with painful hip OA. After completing the baseline assessment, participants will be randomly assigned to either: i) digital exercise intervention; or ii) digital education (control). Participants randomised to the intervention group will have access to a website that provides information about hip OA and its management, advice about increasing their physical activity levels, a 24-week lower limb strength exercise program to be undertaken at home three times per week, and a mobile app to reinforce home exercise program adherence. Participants in the control group will have access to a website containing only information about hip OA and its management. All participants will be reassessed at 24 weeks after randomisation. Primary outcomes are severity of hip pain while walking using an 11-point numeric rating scale and physical function using the Western Ontario and McMaster Universities Osteoarthritis Index subscale. Secondary outcomes are the Hip dysfunction and Osteoarthritis Outcome Score subscales of pain, hip-related quality of life, and function, sports and recreational activities; global change in hip condition; health-related quality of life; measures of physical activity levels; fear of movement; self efficacy for pain and for exercise; and use of oral pain medications. DISCUSSION: Innovative and scalable approaches to OA education, physical activity, and exercise are required in order to improve exercise participation/engagement and mitigate physical inactivity in the hip OA population. This will help minimise the burden of this major public health issue on individuals and society. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry (ACTRN12622001533785).

Effects of a Massive Open Online Course on osteoarthritis knowledge and pain self-efficacy in people with hip and/or knee osteoarthritis: protocol for the MOOC-OA randomised controlled trial.

BACKGROUND: Osteoarthritis (OA) is a prevalent, chronic joint condition that commonly affects the knee and hip causing pain, impaired function, and reduced quality of life. As there is no cure, the main goal of treatment is to alleviate symptoms via ongoing self-management predominantly consisting of exercise and weight loss (if indicated). However, many people with OA do not feel adequately informed about their condition and management options to self-manage effectively. Patient education is recommended by all OA Clinical Practice Guidelines to support appropriate self-management, but little is known about the optimal delivery method and content. Massive Open Online Courses (MOOCs) are free, interactive, e-learning courses. They have been used to deliver patient education in other chronic health conditions but have not been used in OA. METHODS: A two-arm parallel-design, assessor- and participant-blinded superiority randomised controlled trial. People with persistent knee/hip pain consistent with a clinical diagnosis of knee/hip OA (n = 120) are being recruited from the Australia-wide community. Participants are randomly allocated into one of two groups i) electronic information pamphlet (control group) or ii) MOOC (experimental group). Those allocated to the control group receive access to an electronic pamphlet about OA and its recommended management, currently available from a reputable consumer organisation. Those allocated to the MOOC receive access to a 4-week 4-module interactive consumer-facing e-Learning course about OA and its recommended management. Course design was informed by behaviour theory and learning science, and consumer preferences. The two primary outcomes are OA knowledge and pain self-efficacy with a primary endpoint of 5 weeks and a secondary endpoint of 13 weeks. Secondary outcomes include measures of fear of movement, exercise self-efficacy, illness perceptions, OA management and health professional care seeking intentions, physical activity levels, and actual use of physical activity/exercise and weight loss, pain medication, and health professional care seeking to manage joint symptoms. Clinical outcomes and process measures are also collected. DISCUSSION: Findings will determine whether a comprehensive consumer-facing MOOC improves OA knowledge and confidence to self-manage joint pain compared to a currently available electronic OA information pamphlet. TRIAL REGISTRATION: Prospectively registered (Australian New Zealand Clinical Trials Registry ID: ACTRN12622001490763).

Exercise adherence Mobile app for Knee Osteoarthritis: protocol for the MappKO randomised controlled trial.

BACKGROUND: In people with knee osteoarthritis (OA), ongoing exercise participation, particularly with strengthening exercises, is central to management. Patient adherence to prescribed exercise typically declines once consultations with a clinician have ceased. Mobile applications (apps) can incorporate behaviour change techniques that may assist adherence, potentially optimising clinical outcomes. METHODS: This is a two-arm, pragmatic, superiority randomised trial. One hundred and eighty two Australians with chronic knee pain (clinical knee OA) and who have at least a mild level of physical dysfunction are being recruited. Participants are randomly allocated i) exercise (physiotherapist-prescribed exercise) or; ii) exercise plus app (physiotherapist-prescribed exercise plus access to the 'My Exercise Messages' mobile app). Exercise care comprises two videoconferencing consultations with a physiotherapist over two weeks (30 min each) for a strengthening exercise program, which is then conducted independently at home for 24 weeks without any further physiotherapist consultations. Participants are also provided with exercise resources to facilitate home-based exercise. Those randomised to exercise plus app will download the app after completing the two weeks of physiotherapy consultations and will be instructed by research staff to use the app for the 24 weeks of unsupervised home-based exercises. The app works by tracking completion of weekly exercise sessions, providing regular messages to facilitate weekly exercise and providing personalised messages to help overcome individual barriers to exercise participation. The two primary outcomes are i) self-reported physical function; and ii) number of days strengthening exercises were performed (previous fortnight), with a primary endpoint of 26 weeks and a secondary endpoint of 14 weeks. Secondary outcomes include knee pain severity; knee-related quality of life; global change; exercise program satisfaction; exercise self-efficacy; physical activity; sport and recreation function; another measure of exercise adherence; and willingness to undergo joint replacement. Process measures are also included. DISCUSSION: Findings will determine if a theory-informed mobile app improves exercise adherence and physical function in people with knee OA who have received a home-based strengthening program. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12621000724875. Prospectively registered 9/06/2021.

Moderators of the Effect of a Self-directed Digitally Delivered Exercise Program for People With Knee Osteoarthritis: Exploratory Analysis of a Randomized Controlled Trial.

BACKGROUND: A 24-week self-directed digitally delivered intervention was found to improve pain and function in people with knee osteoarthritis (OA). However, it is possible that this intervention may be better suited to certain subgroups of people with knee OA compared to others. OBJECTIVE: The aim of this study was to explore whether certain individual baseline characteristics moderate the effects of a self-directed digitally delivered intervention on changes in pain and function over 24 weeks in people with knee OA. METHODS: An exploratory analysis was conducted on data from a randomized controlled trial involving 206 people with a clinical diagnosis of knee OA. This trial compared a self-directed digitally delivered intervention comprising of web-based education, exercise, and physical activity program supported by automated exercise behavior change mobile phone text messages to web-based education alone (control). The primary outcomes were changes in overall knee pain (assessed on an 11-point numerical rating scale) and physical function (assessed using the Western Ontario and McMaster Universities Osteoarthritis Index function subscale [WOMAC]) at 24 weeks. Five baseline patient characteristics were selected as the potential moderators: (1) number of comorbidities, (2) number of other painful joints, (3) pain self-efficacy, (4) exercise self-efficacy, and (5) self-perceived importance of exercise. Separate linear regression models for each primary outcome and each potential moderator were fit, including treatment group, moderator, and interaction between treatment group and moderator, adjusting for the outcome at baseline. RESULTS: There was evidence that pain self-efficacy moderated the effect of the intervention on physical function compared to the control at 24 weeks (interaction P=.02). Posthoc assessment of the mean change in WOMAC function by treatment arm showed that each 1-unit increase in baseline pain self-efficacy was associated with a 1.52 (95% CI 0.27 to 2.78) unit improvement in the control group. In contrast, a reduction of 0.62 (95% CI -1.93 to 0.68) units was observed in the intervention group with each unit increase in pain self-efficacy. There was only weak evidence that pain self-efficacy moderated the effect of the intervention on pain and that number of comorbidities, number of other painful joints, exercise self-efficacy, or exercise importance moderated the effect of the intervention on pain or function. CONCLUSIONS: With the exception of pain self-efficacy, which moderated changes in function but not pain, we found limited evidence that our selected baseline patient characteristics moderated intervention outcomes. This indicates that people with a range of baseline characteristics respond similarly to the unsupervised digitally delivered exercise intervention. As these findings are exploratory in nature, they require confirmation in future studies.

Behavior Change Text Messages for Home Exercise Adherence in Knee Osteoarthritis: Randomized Trial.

BACKGROUND: Exercise is a core recommended treatment for knee osteoarthritis (OA), yet adherence declines, particularly following cessation of clinician supervision. OBJECTIVE: This study aims to evaluate whether a 24-week SMS intervention improves adherence to unsupervised home exercise in people with knee OA and obesity compared with no SMS. METHODS: A two-group superiority randomized controlled trial was performed in a community setting. Participants were people aged 50 years with knee OA and BMI ≥30 kg/m2 who had undertaken a 12-week physiotherapist-supervised exercise program as part of a preceding clinical trial. Both groups were asked to continue their home exercise program unsupervised three times per week for 24 weeks and were randomly allocated to a behavior change theory-informed, automated, semi-interactive SMS intervention addressing exercise barriers and facilitators or to control (no SMS). Primary outcomes were self-reported home exercise adherence at 24 weeks measured by the Exercise Adherence Rating Scale (EARS) Section B (0-24, higher number indicating greater adherence) and the number of days exercised in the past week (0-3). Secondary outcomes included self-rated adherence (numeric rating scale), knee pain, physical function, quality of life, global change, physical activity, self-efficacy, pain catastrophizing, and kinesiophobia. RESULTS: A total of 110 participants (56 SMS group and 54 no SMS) were enrolled and 99 (90.0%) completed both primary outcomes (48/56, 86% SMS group and 51/54, 94% no SMS). At 24 weeks, the SMS group reported higher EARS scores (mean 16.5, SD 6.5 vs mean 13.3, SD 7.0; mean difference 3.1, 95% CI 0.8-5.5; P=.01) and more days exercised in the past week (mean 1.8, SD 1.2 vs mean 1.3, SD 1.2; mean difference 0.6, 95% CI 0.2-1.0; P=.01) than the control group. There was no evidence of between-group differences in secondary outcomes. CONCLUSIONS: An SMS program increased self-reported adherence to unsupervised home exercise in people with knee OA and obesity, although this did not translate into improved clinical outcomes. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry 12617001243303; https://tinyurl.com/y2ud7on5. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12891-019-2801-z.

Effectiveness of internet-delivered education and home exercise supported by behaviour change SMS on pain and function for people with knee osteoarthritis: a randomised controlled trial protocol.

BACKGROUND: Knee osteoarthritis (OA) is a prevalent and chronic condition with no known cure. Exercise is advocated in all clinical guidelines due to its positive effects on symptoms. Despite this, exercise participation is often poor in people with knee OA with access to exercise treatments a known barrier. Internet-delivered exercise interventions have the potential to improve access to evidence-based exercise treatments and can benefit OA outcomes, although non-usage and low adherence potentially limit their effectiveness. Short message services (SMS) show promise in facilitating exercise adherence and may be one solution to improve adherence to internet-delivered exercise interventions. The combination of internet-delivered exercise and SMS adherence support has not been specifically evaluated in people with knee OA. METHODS: This protocol reports a two-arm parallel-design, assessor- and participant-blinded randomised controlled trial. This trial is recruiting 206 people aged 45 years and older, with a clinical diagnosis of knee OA from the Australian-wide community. Eligible and consenting participants are enrolled and randomised to receive access to either i) 'My Knee Education', an education control website containing OA and exercise information only or ii) a combined intervention that includes a website, 'My Knee Exercise', containing the same educational information as the control, guidance to increase general physical activity, and the prescription of a 24-week self-directed home-based lower-limb strengthening program in addition to a 24-week behaviour change SMS exercise adherence program. Outcome measures are being collected at baseline and 24-weeks. Primary outcomes are self-reported knee pain and physical function. Secondary outcomes include another self-reported measure of knee pain, function in sport and recreation, quality-of-life, physical activity, self-efficacy, participant satisfaction and perceived global change. DISCUSSION: This randomised controlled trial will provide evidence about the effectiveness of a combined intervention of internet-delivered OA and exercise education, physical activity guidance and prescription of a 24-week lower-limb strengthening exercise program supported by a behaviour change SMS program compared to internet delivered OA and exercise education alone. TRIAL REGISTRATION: ACTRN12618001167257/13th July 2018.

Effect of a short message service (SMS) intervention on adherence to a physiotherapist-prescribed home exercise program for people with knee osteoarthritis and obesity: protocol for the ADHERE randomised controlled trial.

BACKGROUND: Knee osteoarthritis (OA) is a highly prevalent condition. People with knee OA often have other co-morbidities such as obesity. Exercise is advocated in all clinical guidelines for the management of knee OA. It is often undertaken as a home-based program, initially prescribed by a physiotherapist or other qualified health care provider. However, adherence to home-based exercise is often poor, limiting its ability to meaningfully change clinical symptoms of pain and/or physical function. While the efficacy of short message services (SMS) to promote adherence to a range of health behaviours has been demonstrated, its ability to promote home exercise adherence in people with knee OA has not been specifically evaluated. Hence, this trial is investigating whether the addition of an SMS intervention to support adherence to prescribed home-based exercise is more effective than no SMS on self-reported measures of exercise adherence. METHODS: We are conducting a two-arm parallel-design, assessor-and participant-blinded randomised controlled trial (ADHERE) in people with knee OA and obesity. The trial is enrolling participants exiting from another randomised controlled trial, the TARGET trial, where participants are prescribed a 12-week home-based exercise program (either weight bearing functional exercise or non-weight bearing quadriceps strengthening exercise) for their knee by a physiotherapist and seen five times over the 12 weeks for monitoring and supervision. Following completion of outcome measures for the TARGET trial, participants are immediately enrolled into the ADHERE trial. Participants are asked to continue their prescribed home exercise program unsupervised three times a week for 24-weeks and are randomly allocated to receive a behaviour change theory-informed SMS intervention to support home exercise adherence or to have no SMS intervention. Outcomes are measured at baseline and 24-weeks. Primary outcomes are self-reported adherence measures. Secondary outcomes include self-reported measures of knee pain, physical function, quality-of-life, physical activity, self-efficacy, kinesiophobia, pain catastrophising, participant-perceived global change and an additional adherence measure. DISCUSSION: Findings will provide new information into the potential of SMS to improve longer-term exercise adherence and ultimately enhance exercise outcomes in knee OA. TRIAL REGISTRATION: Prospectively registered with the Australian New Zealand Clinical Trials Registry. Reference: ACTR N12617001243303 Date/version: August 2019/two.

Comparison of weight bearing functional exercise and non-weight bearing quadriceps strengthening exercise on pain and function for people with knee osteoarthritis and obesity: protocol for the TARGET randomised controlled trial.

BACKGROUND: Clinical guidelines recommend exercise as a core treatment for individuals with knee osteoarthritis (OA). However, the best type of exercise for clinical benefits is not clear, particularly in different OA subgroups. Obesity is a common co-morbidity in people with knee OA. There is some evidence suggesting that non-weight bearing exercise may be more effective than weight bearing exercise in patients with medial knee OA and obesity. METHODS: To compare the efficacy of two different exercise programs (weight bearing functional exercise and non-weight bearing quadriceps strengthening) on pain and physical function for people ≥50 years with painful medial knee OA and obesity (body mass index ≥30 kg/m2) 128 people in Melbourne, Australia will be recruited for a two group parallel-design, assessor- and participant-blinded randomised controlled trial. Participants will be randomly allocated to undertake a program of either weight bearing functional exercise or non-weight bearing quadriceps strengthening exercise. Both groups will attend five individual sessions with a physiotherapist who will teach, monitor and progress the exercise program. Participants will be asked to perform the exercises at home four times per week for 12 weeks. Outcomes will be measured at baseline and 12 weeks. Primary outcomes are self-reported knee pain and physical function. Secondary outcomes include other measures of knee pain, physical function, quality-of-life, participant-perceived global change, physical performance, and lower limb muscle strength. DISCUSSION: This study will compare the efficacy of two different 12-week physiotherapist-prescribed, home-based exercise programs for people with medial knee OA and obesity. Findings will provide valuable information to help inform exercise prescription in this common OA patient subgroup. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry reference: ACTRN12617001013358 , 14/7/2017.

Virtual Tools to Enable Management of Knee Osteoarthritis.

Purpose of review: There is increasing recognition that virtual tools, enabled by the internet and telecommunications technology, can increase access to health care. We review evidence about the clinical effectiveness and acceptability of telephone-delivered and videoconferencing clinician consultations, websites and internet-delivered programs, and SMS and mobile applications in enabling the management of people with knee osteoarthritis (OA). We discuss barriers to using virtual tools and suggest strategies to facilitate implementation in clinical settings. Recent findings: An increasing number of systematic reviews, meta-analyses, and clinical trials provide evidence showing the effectiveness of virtual tools for improving knee OA management. Qualitative research shows that virtual tools increase patient access to knee OA care, are generally acceptable and convenient for patients, but can be associated with barriers to use from patient and clinician perspectives. Summary: Virtual tools offer new opportunities to enable people with knee OA to manage their condition and receive care that may otherwise be difficult or not possible to access. Telephone calls and videoconferencing can be used for real-time synchronous consultations between clinicians and patients, increasing the geographic reach of health services. Websites and internet-based programs can be used to educate patients about their condition, as well as deliver exercise, weight management, and psychological interventions. Mobile apps can monitor and track OA symptoms, exercise, and physical activity, while SMS can facilitate positive behaviour changes for self-management over the long-term when sustained clinician contact may not be possible.

Development of a consumer involvement strategy for a small university-based musculoskeletal research centre.

OBJECTIVE: To develop a Consumer Involvement Strategy which adheres to best practice recommendations and is feasible to implement in a small musculoskeletal research centre funded solely by external grants. METHODS: The Strategy development involved five collaborative and iterative stages: (1) conceptualisation and initial consultation; (2) formation of the Consumer Involvement Strategy Action Group; (3) defining the scope and developing the strategy; (4) consultation and refinement; and (5) presentation and implementation. The final three stages were overseen by a Consumer Involvement Strategy Action Group comprising two post-doctoral research fellows, a PhD student representative, and two consumers (people with osteoarthritis), all with experience in consumer involvement activities in research. RESULTS: The final strategy aligns with best practice recommendations and includes five unique levels of consumer involvement that were devised to encompass the wide variety of consumer involvement activities across the research centre. It includes a policy document with five strategic aims, each supported by an implementation plan, and includes a suite of resources for researchers and consumers to support its application. CONCLUSION: The Consumer Involvement Strategy and its described development may serve as a template for other research teams facing similar resource constraints, both at a national and international level.

Absence of Improvement With Exercise in Some Patients With Knee Osteoarthritis: A Qualitative Study of Responders and Nonresponders.

OBJECTIVE: To compare the perceptions of patients about why they did, or did not, respond to a physical therapist-supported exercise and physical activity program. METHODS: This was a qualitative study within a randomized controlled trial. Twenty-six participants (of 40 invited) with knee osteoarthritis sampled according to response (n = 12 responders, and 14 nonresponders based on changes in both pain and physical function at 3 and 9 months after baseline) to an exercise and physical activity intervention. Semistructured individual interviews were conducted. Inductive thematic analysis was undertaken within each subgroup using grounded theory principles. A deductive approach compared themes and subthemes across subgroups. Findings were triangulated with quantitative data. RESULTS: (Sub)themes common to responders and nonresponders included the intervention components that facilitated engagement, personal attitudes and expectations, beliefs about osteoarthritis and exercise role, importance of adherence, and perceived strength gains with exercise. In contrast to responders who felt empowered to self-manage, nonresponders accepted responsibility for lack of improvement in pain and function with exercise, acknowledging that their adherence to the intervention was suboptimal (confirmed by quantitative adherence data). Nonresponders believed that their excess body weight (supported by quantitative data) contributed to their outcomes, encountered exercise barriers (comorbidities, stressors, and life events), and perceived that the trial measurement tools did not adequately capture their response to exercise. CONCLUSION: Responders and nonresponders shared some similar perceptions of exercise. However, along with perceived limitations in trial outcome measurements, nonresponders encountered challenges with excess weight, comorbidities, stressors, and life events that led to suboptimal adherence and collectively were perceived to contribute to nonresponse.

Adherence to a Web-based Exercise Programme: A Feasibility Study Among Patients with Hip or Knee Osteoarthritis.

OBJECTIVES: To describe adherence to a 12-week web-based aerobic exercise programme, to compare characteristics between those who adhere or not, and to identify barriers for exercising in patients with hip or knee osteoarthritis. DESIGN: Single-arm feasibility study. SUBJECTS: Patients with hip or knee osteoarthritis in specialist healthcare, age 40-80 years, and not candidates for joint surgery. METHODS: Adherence to a 12-week exercise programme was defined as having completed ≥ 2 exercise sessions a week for at least 8 weeks. Baseline differences between adherent and non-adherent groups in demographics, symptoms, disability, physical activity and fitness were assessed using Mann-Whitney U or χ2 tests. Reasons for not completing exercise sessions were reported in weekly diaries.  Results: A total of 29 patients (median age 64 years, 72% female) were included. Median baseline pain (numerical rating scale 0-10) was 5. Fifteen patients adhered to the exercise programme, 14 did not. Non-adherent patients were less active (p = 0.032) and had lower cardiorespiratory fitness (p = 0.031). The most frequently reported barrier to exercising was sickness. Less than 10% reported pain as a barrier. CONCLUSION: Half of the patients with hip or knee osteoarthritis adhered to the digitally delivered exercise programme and the most frequently reported barrier for adherence was sickness, while less than 10% reported pain as a reason for not exercising. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04084834. The Regional Committee for Medical and Health Research Ethics South-East, 2018/2198.

The AktiWeb study: feasibility of a web-based exercise program delivered by a patient organisation to patients with hip and/or knee osteoarthritis.

BACKGROUND: Patient organisations may be an under-utilised resource in follow-up of patients requiring long-term exercise as part of their disease management. The purpose of this study was to explore the feasibility of a web-based exercise program delivered by a patient organisation to patients with hip and/or knee osteoarthritis (OA). METHODS: In this pre-post feasibility study, patients aged 40-80 years with hip and/or knee OA were recruited from Diakonhjemmet Hospital. The 12-week intervention was delivered through a patient organisation's digital platform. Feasibility was evaluated by proportion of eligible patients enrolled, proportion of enrolled patients who provided valid accelerometer data at baseline, and proportion completing the cardiorespiratory exercise test according to protocol at baseline and completed follow-up assessments. Patient acceptability was evaluated for website usability, satisfaction with the initial exercise level and comprehensibility of the exercise program. Change in clinical outcomes were assessed for physical activity, cardiorespiratory fitness and patient-reported variables. RESULTS: In total, 49 eligible patients were identified and 35 were enrolled. Thirty (86%) of these attended baseline assessments and provided valid accelerometer data and 18 (51%) completed the maximal cardiorespiratory exercise test according to protocol. Twenty-two (63%) patients completed the follow-up questionnaire, and they rated the website usability as 'acceptable' [median 77.5 out of 100 (IQR 56.9, 85.6)], 19 (86%) reported that the initial exercise level was 'just right' and 18 (82%) that the exercise program was 'very easy' or 'quite easy' to comprehend. Improvement in both moderate to vigorous physical activity (mean change 16.4 min/day; 95% CI 6.9 to 25.9) and cardiorespiratory fitness, VO2peak (mean change 1.83 ml/kg/min; 95% CI 0.29 to 3.36) were found in a subgroup of 8 patients completing these tests. Across all patient-reported outcomes 24-52% of the patients had a meaningful improvement (n = 22). CONCLUSION: A web-based exercise program delivered by a patient organisation was found to be feasible and acceptable in patients with hip and/or knee OA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04084834 (registered 10 September 2019). The Regional Committee for Medical and Health Research Ethics south-east, 2018/2198. URL: Prosjekt #632074 - Aktiv med web-basert støtte. - Cristin (registered 7 June 2019).

Evaluation of two electronic-rehabilitation programmes for persistent knee pain: protocol for a randomised feasibility trial.

INTRODUCTION: Persistent, knee pain is a common cause of disability. Education and exercise treatment are advocated in all clinical guidelines; however, the increasing prevalence of persistent knee pain presents challenges for health services regarding appropriate and scalable delivery of these treatments. Digital technologies may help address this, and this trial will evaluate the feasibility and acceptability of two electronic-rehabilitation interventions: 'My Knee UK' and 'Group E-Rehab'. METHODS AND ANALYSIS: This protocol describes a non-blinded, randomised feasibility trial with three parallel groups. The trial aims to recruit 90 participants (45 years or older) with a history of persistent knee pain consistent with a clinical diagnosis of knee osteoarthritis. Participants will be randomly assigned in a 1:1:1 allocation ratio. The 'My Knee UK' intervention arm will receive a self-directed unsupervised internet-based home exercise programme plus short message service support (targeting exercise behaviour change) for 12 weeks; the 'Group E-Rehab' intervention arm will receive group-based physiotherapist-prescribed home exercises delivered via videoconferencing accompanied by internet-interactive educational sessions for 12 weeks; the control arm will receive usual physiotherapy care or continue with their usual self-management (depending on their recruitment path). Feasibility variables, patient-reported outcomes and clinical findings measured at baseline, 3 and 9 months will be assessed and integrated with qualitative interview data from a subset of Group E-Rehab and My Knee UK participants. If considered feasible and acceptable, a definitive randomised controlled trial can be conducted to investigate the clinical effectiveness and cost-effectiveness of one or both interventions with a view to implementation in routine care. ETHICS AND DISSEMINATION: The trial was approved by the West of Scotland Research Ethics Committee 5 (Reference: 20/WS/0006). The results of the study will be disseminated to study participants, the study grant funder and will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN15564385.

Effects of a Self-directed Web-Based Strengthening Exercise and Physical Activity Program Supported by Automated Text Messages for People With Knee Osteoarthritis: A Randomized Clinical Trial.

Importance: Exercise therapies are advocated in osteoarthritis (OA) clinical guidelines. However, challenges to accessing exercise may be limiting widespread uptake. Objective: To evaluate the effects of a self-directed web-based strengthening exercise and physical activity program supported by automated behavior-change text messages on knee pain and function for people with knee OA. Design, Setting, and Participants: The participant-blinded and assessor-blinded randomized clinical trial enrolled 206 people who met clinical criteria for knee OA in communities across Australia from July 2018 to August 2019, with follow-up taking place at 24 weeks. Interventions: The control group was given access to a custom-built website with information on OA and the importance of exercise and physical activity. The intervention group was given access to the same information plus a prescription for a 24-week self-directed strengthening regimen and guidance to increase physical activity, supported by automated behavior-change text messages encouraging exercise adherence. Main Outcomes and Measures: Primary outcomes were change in overall knee pain (numeric rating scale, 0-10) and difficulty with physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0-68) over 24 weeks. Secondary outcomes were another knee pain measure, sport and recreation function, quality of life, physical activity, self-efficacy, overall improvement, and treatment satisfaction. Results: Of 206 participants, 180 (87%; mean [SD] age, 60 [8.4] years; 109 [61%] women) completed both 24-week primary outcomes. The intervention group showed greater improvements in overall knee pain (mean difference, 1.6 units; 95% CI, 0.9-2.2 units; P < .001) and physical function (mean difference, 5.2 units; 95% CI, 1.9-8.5 units; P = .002) compared with the control. There was evidence of differences in the proportion of participants exceeding the minimal clinically important improvement in pain (intervention group, 72.1%, vs control, 42.0%; risk difference, 0.30 [95% CI, 0.16-0.44]; P <. 001) and function (intervention group, 68%, vs control, 40.8%; risk difference, 0.27 [95% CI, 0.13-0.41]; P < .001) favoring the intervention. Between-group differences for all secondary outcomes favored the intervention except for physical activity, self-efficacy for function, and self-efficacy for exercise, for which there was no evidence of differences. Conclusions and Relevance: This randomized clinical trial found that a self-directed web-based strengthening exercise regimen and physical activity guidance supported by automated behavior-change text messages to encourage exercise adherence improved knee pain and function at 24 weeks. This unsupervised, free-to-access digital intervention is an effective option to improve patient access to recommended OA exercise and/or to support clinicians in providing exercise management for people with knee OA at scale across the population. Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12618001167257.

Comparative effectiveness of exercise programs for psychological well-being in knee osteoarthritis: A systematic review and network meta-analysis.

OBJECTIVES: The benefits of exercise are well established for psychological well-being, but it is unknown whether one type of exercise can be recommended over another for psychological well-being in knee osteoarthritis (OA). This study aimed to compare the effectiveness of different types of exercise on psychological well-being in people with knee OA. METHODS: Five databases including MEDLINE, EMBASE, Cochrane Register of Controlled Trials, CINAHL and PEDro) were searched from inception until April 2021. Randomised controlled trials comparing the effect of exercise with a non-exercise control or another type of exercise on overall mental health, depressive symptoms or anxiety in people with knee OA. Trial data were extracted independently by two researchers. Network meta-analyses using random-effect models were conducted. The Grading of Recommendations, Assessment, Development and Evaluation framework was used to appraise evidence certainty. RESULTS: Strengthening exercise was more beneficial for overall mental health on the Short Form survey compared to aerobic (mean difference 15.88, 95%CI [6.77, 24.99]), mixed (12.77, 95%CI [5.12, 20.42]) and mind-body (12.51, [4.25, 20.77]) exercise based on 13 trials (n = 796). Strengthening exercise (standardised mean difference 6.81, [5.03, 8.58]), and mixed exercise (6.64, [4.88, 8.40]),) were more beneficial for depressive symptoms than stretching exercise based on 6 trials (n = 627). No differences were observed for anxiety based on 4 trials (n = 557). Certainty of the evidence ranged from very low to low. CONCLUSION: The available evidence supports the recommendation of strengthening exercise as the most beneficial for overall mental health, and strengthening exercise or mixed exercise over stretching exercise for depressive symptoms. No exercise recommendations can be made for anxiety.

Exploring Attitudes and Experiences of People With Knee Osteoarthritis Toward a Self-Directed eHealth Intervention to Support Exercise: Qualitative Study.

BACKGROUND: Knee osteoarthritis (OA) is a highly prevalent and debilitating condition. Exercise is a recommended treatment because of its effectiveness at improving pain and function. However, exercise is underutilized in OA management. Difficulty accessing health care has been identified as a key barrier to exercise uptake. Innovative and scalable methods of delivering exercise treatments to people with knee OA are needed. We developed a self-directed eHealth intervention to enable and encourage exercise participation. The effectiveness of this intervention on pain and function in people with knee OA is being evaluated in a randomized clinical trial. OBJECTIVE: This study aimed to explore the attitudes and experiences of people with knee OA who accessed the self-directed eHealth intervention and the features perceived as useful to facilitate self-directed exercise. METHODS: This was a qualitative study embedded within a randomized controlled trial. Individual, semistructured phone interviews were conducted with 16 people with knee OA who had accessed a 24-week eHealth intervention (website and behavior change SMS program) designed to support exercise participation. Interviews were audiorecorded, transcribed verbatim, and thematically analyzed using an inductive approach. RESULTS: Five themes arose: (1) technology easy to use and follow (website ease of use, SMS ease of use), (2) facilitators to exercise participation (credible OA and exercise information, website features, prescribed exercises simple to do unsupervised, freedom to adapt the exercise to suit needs, influence of other health care experiences), (3) sense of support and accountability (SMS good reminder and prompt, accountable, SMS tone and automation could trigger negative emotions [eg, guilt or shame], inability to contact someone when needed), (4) positive outcomes (knee symptom improvements, confidence to self-manage, encouraged active living), (5) suggestions for real-world application (provided by a health professional preferred, should be provided at subsidized or low out-of-pocket cost). CONCLUSIONS: People with knee OA had mostly positive experiences with and attitudes towards the use of an eHealth intervention that supported exercise participation independent of a health professional. A human connection associated with the eHealth intervention appeared important.

"I Could Do It in My Own Time and When I Really Needed It": Perceptions of Online Pain Coping Skills Training For People With Knee Osteoarthritis.

OBJECTIVE: To qualitatively explore the perceptions and experiences of people with knee osteoarthritis (OA) who used an online automated pain coping skills training program (PCST). METHODS: This was a descriptive qualitative study (based on interpretivist methodology) embedded within a randomized controlled trial. Individual semistructured interviews were conducted with 12 people with knee OA who had participated in an 8-week automated online PCST program while also receiving exercise advice and support from a physical therapist via Skype. Interviews in this study focused specifically on the online PCST program, rather than the physical therapy component. Interviews were audiorecorded, transcribed verbatim, and thematically analyzed. RESULTS: Five themes arose: 1) easy to understand and follow (clearly explained, presented well), 2) better able to cope with pain (controlling pain, helping relax, pacing self, incorporating skills into exercise program), 3) anonymity and flexibility (no judgement by clinician, work at own pace, accessibility), 4) not always relatable or engaging (some techniques not useful, Americanization of the program, annoying character examples, time consuming and slow-paced), and 5) support from clinician desirable (follow-up from a clinician would be beneficial, worked in tandem with physical therapist-prescribed exercise, desire referral to the program by a trusted source). CONCLUSION: People with knee OA had generally positive experiences using an online PCST program, suggesting that online PCST is a broadly acceptable and accessible way to help people with OA to manage their pain. User engagement may be enhanced by redesigning some aspects of the program and by provision of support from a clinician.

A Short Message Service Intervention to Support Adherence to Home-Based Strengthening Exercise for People With Knee Osteoarthritis: Intervention Design Applying the Behavior Change Wheel.

BACKGROUND: Knee osteoarthritis is a chronic condition with no known cure. Treatment focuses on symptom management, with exercise recommended as a core component by all clinical practice guidelines. However, long-term adherence to exercise is poor among many people with knee osteoarthritis, which limits its capacity to provide sustained symptom relief. To improve exercise outcomes, scalable interventions that facilitate exercise adherence are needed. SMS (short message service) interventions show promise in health behavior change. The Behavior Change Wheel (BCW) is a widely used framework that provides a structured approach to designing behavior change interventions and has been used extensively in health behavior change intervention design. OBJECTIVE: The study aimed to describe the development of, and rationale for, an SMS program to support exercise adherence in people with knee osteoarthritis using the BCW framework. METHODS: The intervention was developed in two phases. Phase 1 involved using the BCW to select the target behavior and associated barriers, facilitators, and behavior change techniques (BCTs). Phase 2 involved design of the program functionality and message library. Messages arranged into a 24-week schedule were provided to an external company to be developed into an automated SMS program. RESULTS: The target behavior was identified as participation in self-directed home-based strengthening exercise 3 times a week for 24 weeks. A total of 13 barriers and 9 facilitators of the behavior and 20 BCTs were selected to use in the intervention. In addition, 198 SMS text messages were developed and organized into a 24-week automated program that functions by prompting users to self-report the number of home exercise sessions completed each week. Users who reported ≥3 exercise sessions/week (adherent) received positive reinforcement messages. Users who reported <3 exercise sessions/week (nonadherent) were asked to select a barrier (from a list of standardized response options) that best explains why they found performing the exercises challenging in the previous week. This automatically triggers an SMS containing a BCT suggestion relevant to overcoming the selected barrier. Users also received BCT messages to facilitate exercise adherence, irrespective of self-reported adherence. CONCLUSIONS: This study demonstrates application of the BCW to guide development of an automated SMS intervention to support exercise adherence in knee osteoarthritis. Future research is needed to assess whether the intervention improves adherence to the prescribed home-based strengthening exercise.