Telehealth exercise for continence after gynaecological cancer treatment (TELE-CONNECT): a protocol for a co-designed pragmatic randomised controlled trial.

BACKGROUND: Urinary incontinence (UI) is the most prevalent pelvic floor disorder following treatment for gynaecological cancer with a distressing impact on quality-of-life in survivors. Physiotherapist-supervised pelvic floor muscle (PFM) training is recommended as the first-line intervention for UI in community-dwelling women. However, it is not known if this intervention is effective in women following treatment for gynaecological cancer, nor whether PFM training can be delivered entirely remotely. The primary aim of this study is to investigate if a telehealth-delivered PFM training program incorporating a novel biofeedback device reduces UI compared with usual care, following gynaecological cancer. METHODS: This is a pragmatic, two-arm parallel-group, stratified superiority randomised controlled trial recruiting 72 participants (ACTRN12622000580774). Recruitment sites include gynaecology-oncology outpatient clinics, supplemented by advertisements through community foundations/social media/care groups. Participants must have completed primary cancer treatment at least 6 months prior or adjuvant therapy at least 3 months prior, for Stage I, II or III uterine, cervical, fallopian tube, primary peritoneal or ovarian cancer or borderline ovarian tumour, and have UI occurring at least weekly. Participants randomised to the usual care group will receive bladder and bowel advice handouts and one audio telehealth physiotherapist consultation to answer any queries about the handouts. Participants randomised to the intervention group will receive the same handouts plus eight video telehealth physiotherapist consultations for PFM training with a biofeedback device (femfit®), alongside a home-based program over 16 weeks. The primary outcome measure is a patient-reported outcome of UI frequency, amount and interference with everyday life (measured using the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form), immediately post-intervention compared with baseline. Secondary outcomes include quality-of-life measures, bother of pelvic floor symptoms, leakage episodes, use of continence pads and global impression of change. We will also investigate if the intervention improves intra-vaginal resting and squeeze pressure in women in the intervention arm, using data from the biofeedback device. DISCUSSION: If clinical effectiveness of telehealth-delivered physiotherapist-supervised PFM training, supplemented with home biofeedback is shown, this will allow this therapy to enter pathways of care, and provide an evidence-based option for treatment of post-cancer UI not currently available. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR), ID 12622000580774. Registered 20 April 2022.

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.

Effectiveness of an Internet-Delivered Exercise and Pain-Coping Skills Training Intervention for Persons With Chronic Knee Pain: A Randomized Trial.

BACKGROUND: Effective, accessible biopsychosocial treatments are needed to manage chronic knee pain on a population level. OBJECTIVE: To evaluate the effectiveness of Internet-delivered, physiotherapist-prescribed home exercise and pain-coping skills training (PCST). DESIGN: Pragmatic parallel-group randomized, controlled trial. (Australian New Zealand Clinical Trials Registry: ACTRN12614000243617). SETTING: Community (Australia). PATIENTS: 148 persons aged 50 years or older with chronic knee pain. INTERVENTION: The intervention was delivered via the Internet and included educational material, 7 videoconferencing (Skype [Microsoft]) sessions with a physiotherapist for home exercise, and a PCST program over 3 months. The control was Internet-based educational material. MEASUREMENTS: Primary outcomes were pain during walking (11-point numerical rating scale) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index) at 3 months. Secondary outcomes were knee pain, quality of life, global change (overall, pain, and functional status), arthritis self-efficacy, coping, and pain catastrophizing. Outcomes were also measured at 9 months. RESULTS: Of participants enrolled, 139 (94%) completed primary outcome measures at 3 months and 133 (90%) completed secondary outcome measures at 9 months; multiple imputation was used for missing data. The intervention group reported significantly more improvement in pain (mean difference, 1.6 units [95% CI, 0.9 to 2.3 units]) and physical function (mean difference, 9.3 units [CI, 5.9 to 12.7 units]) than the control group at 3 months, and improvements were sustained at 9 months (mean differences, 1.1 units [CI, 0.4 to 1.8 units] and 7.0 units [CI, 3.4 to 10.5 units], respectively). Intervention participants showed significantly more improvement in most secondary outcomes than control participants. At both time points, significantly more intervention participants reported global improvements. LIMITATION: Participants were unblinded. CONCLUSION: For persons with chronic knee pain, Internet-delivered, physiotherapist-prescribed exercise and PCST provide clinically meaningful improvements in pain and function that are sustained for at least 6 months. PRIMARY FUNDING SOURCE: National Health and Medical Research Council.

Moderators of Effects of Internet-Delivered Exercise and Pain Coping Skills Training for People With Knee Osteoarthritis: Exploratory Analysis of the IMPACT Randomized Controlled Trial.

BACKGROUND: Internet-delivered exercise, education, and pain coping skills training is effective for people with knee osteoarthritis, yet it is not clear whether this treatment is better suited to particular subgroups of patients. OBJECTIVE: The aim was to explore demographic and clinical moderators of the effect of an internet-delivered intervention on changes in pain and physical function in people with knee osteoarthritis. METHODS: Exploratory analysis of data from 148 people with knee osteoarthritis who participated in a randomized controlled trial comparing internet-delivered exercise, education, and pain coping skills training to internet-delivered education alone. Primary outcomes were changes in knee pain while walking (11-point Numerical Rating Scale) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index function subscale) at 3 and 9 months. Separate regression models were fit with moderator variables (age, gender, expectations of outcomes, self-efficacy [pain], education, employment status, pain catastrophizing, body mass index) and study group as covariates, including an interaction between the two. RESULTS: Participants in the intervention group who were currently employed had significantly greater reductions in pain at 3 months than similar participants in the control group (between-group difference: mean 2.38, 95% CI 1.52-3.23 Numerical Rating Scale units; interaction P=.02). Additionally, within the intervention group, pain at 3 months reduced by mean 0.53 (95% CI 0.28-0.78) Numerical Rating Scale units per unit increase in baseline self-efficacy for managing pain compared to mean 0.11 Numerical Rating Scale units (95% CI -0.13 to 0.35; interaction P=.02) for the control group. CONCLUSIONS: People who were employed and had higher self-efficacy at baseline were more likely to experience greater improvements in pain at 3 months after an internet-delivered exercise, education, and pain coping skills training program. There was no evidence of a difference in the effect across gender, educational level, expectation of treatment outcome, or across age, body mass index, or tendency to catastrophize pain. Findings support the effectiveness of internet-delivered care for a wide range of people with knee osteoarthritis, but future confirmatory research is needed. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12614000243617; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365812&isReview=true (Archived by WebCite at http://www.webcitation.org/6z466oTPs).

General practitioners' perspectives on a proposed new model of service delivery for primary care management of knee osteoarthritis: a qualitative study.

BACKGROUND: Effective management of people with knee osteoarthritis (OA) requires development of new models of care, and successful implementation relies on engagement of general practitioners (GPs). This study used a qualitative methodology to identify potential factors influencing GPs' engagement with a proposed new model of service delivery to provide evidence-based care for patients with knee OA and achieve better patient outcomes. METHODS: Semi-structured telephone interviews with 11 GPs were conducted. Based on a theoretical model of behaviour, interview questions were designed to elicit perspectives on a remotely-delivered (telephone-based) service to support behaviour change and self-management for patients with knee OA, with a focus on exercise and weight loss. Transcripts were analysed using an inductive thematic approach, and GPs' opinions were organised using the APEASE (affordability, practicability, effectiveness, acceptability, safety/side effects and equity) criteria as themes. RESULTS: GPs expressed concerns about potential for confusion, incongruence of information and advice, disconnect with other schemes and initiatives, loss of control of patient care, lack of belief in the need and benefits of proposed service, resistance to change because of lack of familiarity with the procedures and the service, and reluctance to trust in the skills and abilities of the health professionals providing the care support. GPs also recognised the potential benefits of the extra support for patients, and improved access for remote patients to clinicians with specialist knowledge. CONCLUSION: The findings can be used to optimise implementation and engagement with a remotely-delivered 'care support team' model by GPs.

Internet-mediated physiotherapy and pain coping skills training for people with persistent knee pain (IMPACT - knee pain): a randomised controlled trial protocol.

BACKGROUND: Persistent knee pain in people over 50 years of age is often attributable to knee osteoarthritis (OA), a common joint condition that causes physical and psychological dysfunction. Exercise and pain coping skills training (PCST) can help reduce the impact of persistent knee pain, however, access to health professionals who deliver these services can be challenging. With increasing access to the Internet, remotely delivered Internet-based treatment approaches may provide alternatives for healthcare delivery. This pragmatic randomised controlled trial will investigate whether an Internet-delivered intervention that combines PCST and physiotherapist-guided exercise (PCST + Ex) is more effective than online educational material (educational control) in people with persistent knee pain. METHODS/DESIGN: We will recruit 148 people over 50 years of age with self-reported persistent knee pain consistent with knee OA from the Australian community. Following completion of baseline questionnaires, participants will be randomly allocated to access a 3-month intervention of either (i) online educational material, or (ii) the same online material plus an 8-module (once per week) Internet-based PCST program and seven Internet-delivered physiotherapy sessions with a home exercise programs to be performed 3 times per week. Outcomes will be measured at baseline, 3 months and 9 months with the primary time point at 3 months. Primary outcomes are average knee pain on walking (11-point numeric rating scale) and self-reported physical function (Western Ontario and McMaster Universities Osteoarthritis Index subscale). Secondary outcomes include additional measures of knee pain, health-related quality-of-life, perceived global change in symptoms, and potential moderators and mediators of outcomes including self-efficacy for pain management and function, pain coping attempts and pain catastrophising. Other measures of adherence, adverse events, harms, use of health services/co-interventions, and process measures including appropriateness and satisfaction of the intervention, will be collected at 3, 6 and 9 months. DISCUSSION: The findings will help determine the effectiveness and acceptability of Internet access to a combination of interventions that are known to be beneficial to people with persistent knee pain. This study has the potential to guide clinical practice towards innovative modes of healthcare provision. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry reference: ACTRN12614000243617.

Development of a 12-Week Unsupervised Online Tai Chi Program for People With Hip and Knee Osteoarthritis: Mixed Methods Study.

BACKGROUND: Osteoarthritis is a leading contributor to global disability. While evidence supports the effectiveness of Tai Chi in improving symptoms for people with hip/knee osteoarthritis, access to in-person Tai Chi classes may be difficult for many people. An unsupervised online Tai Chi intervention for people with osteoarthritis can help overcome accessibility barriers. The Approach to Human-Centered, Evidence-Driven Adaptive Design (AHEAD) framework provides a practical guide for co-designing such an intervention. OBJECTIVE: This study aims to develop an unsupervised online Tai Chi program for people with hip/knee osteoarthritis. METHODS: An iterative process was conducted using the AHEAD framework. Initially, a panel of Tai Chi instructors and people with osteoarthritis was assembled. A literature review was conducted to inform the content of a survey (survey 1), which was completed by the panel and additional Australian Tai Chi instructors to identify Tai Chi movements for potential inclusion. Selection of Tai Chi movements was based on 3 criteria: those that were appropriate (for people with hip/knee osteoarthritis aged 45+ years), safe (to be performed at home unsupervised), and practical (to be delivered online using prerecorded videos). Movements that met these criteria were then ranked in a second survey (survey 2; using conjoint analysis methodology). Survey findings were discussed in a focus group, and the Tai Chi movements for program use were identified. A draft of the online Tai Chi program was developed, and a final survey (survey 3) was conducted with the panel to rate the appropriateness and safety of the proposed program. The final program was developed, and usability testing (think-aloud protocol) was conducted with people with knee osteoarthritis. RESULTS: The panel consisted of 10 Tai Chi instructors and 3 people with osteoarthritis. The literature review identified Yang Style 24 as a common and effective Tai Chi style used in hip/knee osteoarthritis studies. Surveys 1 (n=35) and 2 (n=27) produced a ranked list of 24 Tai Chi movements for potential inclusion. This list was refined and informed by a focus group, with 10 Tai Chi movements being selected for inclusion (known as the Yang Style 10 form). Survey 3 (n=13) found that 92% (n=12) of the panel members believed that the proposed draft Tai Chi program was appropriate and safe, resulting in its adoption. The final program was produced and hosted on a customized website, "My Joint Tai Chi," which was further refined based on user feedback (n=5). "My Joint Tai Chi" is currently being evaluated in a randomized controlled trial. CONCLUSIONS: This study demonstrates the use of the AHEAD framework to develop an unsupervised online Tai Chi intervention ("My Joint Tai Chi") for people with hip/knee osteoarthritis. This intervention is now being tested for effectiveness and safety in a randomized controlled trial.

Exploring Experiences of People With Knee Osteoarthritis Who Received a Physiotherapist-Delivered Dietary Weight Loss and Exercise Intervention: A Mixed Methods Study.

OBJECTIVE: Explore the experiences of people with knee osteoarthritis (OA) who received a very low energy diet (VLED) and exercise program from a physiotherapist. METHODS: Mixed methods study involving questionnaires (n = 42) and semistructured interviews (n = 22) with randomized control trial participants with knee OA who had received a 6-month physiotherapist-delivered VLED weight loss and exercise intervention. Questionnaires measured participant satisfaction and perceptions about physiotherapist's skills/knowledge in delivery of the dietary intervention (measured on 5-7 point Likert scales). Interviews explored participant's experiences and were analyzed based on the principles of reflexive thematic analysis. RESULTS: Questionnaire response: 90%. Participants were satisfied with the program (95%), confident their physiotherapist had the required skills (84%) and knowledge (79%) to deliver the dietary intervention, felt comfortable talking to the physiotherapist about weight (74%), and would recommend others see a physiotherapist for the intervention they undertook (71%). The following four themes were developed from the interviews: (1) one-stop-shop of exercise and diet; (2) physiotherapist-delivered weight loss works (unsure initially; successfully lost weight); (3) physiotherapists knowledge and skills (exercise is forte; most thought physiotherapists had the necessary weight loss skills/knowledge, but some disagreed); and (4) physiotherapists have a role in weight loss (physiotherapists are intelligent, credible, and trustworthy; specific training in weight loss necessary). CONCLUSION: This study provides, to our knowledge, the first documented perspectives from people with OA who have received a physiotherapist-delivered weight loss intervention. Findings suggest physiotherapists may have a role in delivering a protocolized dietary intervention for some people with knee OA with overweight and obesity.

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).