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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.

ABSTRACT: 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.

SUBMITTER: Nelligan RK

PROVIDER: S-EPMC6661079 | biostudies-other | 2019 Jul

REPOSITORIES: biostudies-other

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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.

Nelligan Rachel K RK Hinman Rana S RS Kasza Jessica J Bennell Kim L KL

BMC musculoskeletal disorders 20190727 1

<h4>Background</h4>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 ...[more]

PMID: 31351449

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Project description:BACKGROUND:Osteoarthritis of the knee is the most common cause for disability and limited mobility in the elderly, with considerable individual suffering and high direct and indirect disease-related costs. Nonsurgical interventions such as exercise, enhanced physical activity, and self-management have shown beneficial effects for pain reduction, physical function, and quality of life (QoL), but access to these treatments may be limited. Therefore, home therapy is strongly recommended. However, adherence to these programs is low. Patients report lack of motivation, feedback, and personal interaction as the main barriers to home therapy adherence. To overcome these barriers, electronic health (eHealth) is seen as a promising opportunity. Although beneficial effects have been shown in the literature for other chronic diseases such as chronic pain, cardiovascular disease, and diabetes, a systematic literature review on the efficacy of eHealth interventions for patients with osteoarthritis of knee is missing so far. OBJECTIVE:The aim of this study was to compare the efficacy of eHealth-supported home exercise interventions with no or other interventions regarding pain, physical function, and health-related QoL in patients with osteoarthritis of the knee. METHODS:MEDLINE, CENTRAL, CINAHL, and PEDro were systematically searched using the keywords osteoarthritis knee, eHealth, and exercise. An inverse variance random-effects meta-analysis was carried out pooling standardized mean differences (SMDs) of individual studies. The Cochrane tool was used to assess risk of bias in individual studies, and the quality of evidence across studies was evaluated following the Grading of Recommendations, Assessment, Development, and Evaluation approach. RESULTS:The literature search yielded a total of 648 results. After screening of titles, abstracts, and full-texts, seven randomized controlled trials were included. Pooling the data of individual studies demonstrated beneficial short-term (pain SMD=−0.31, 95% CI −0.58 to −0.04, low quality; QoL SMD=0.24, 95% CI 0.05-0.43, moderate quality) and long-term effects (pain −0.30, 95% CI −0.07 to −0.53, moderate quality; physical function 0.41, 95% CI 0.17-0.64, high quality; and QoL SMD=0.27, 95% CI 0.06-0.47, high quality). CONCLUSIONS:eHealth-supported exercise interventions resulted in less pain, improved physical function, and health-related QoL compared with no or other interventions; however, these improvements were small (SMD<0.5) and may not make a meaningful difference for individual patients. Low adherence is seen as one limiting factor of eHealth interventions. Future research should focus on participatory development of eHealth technology integrating evidence-based principles of exercise science and ways of increasing patient motivation and adherence.

Project description:BackgroundExercise is a core recommended treatment for knee osteoarthritis (OA), yet adherence declines, particularly following cessation of clinician supervision.ObjectiveThis 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.MethodsA 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.ResultsA 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.ConclusionsAn 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 registrationAustralian New Zealand Clinical Trials Registry 12617001243303; https://tinyurl.com/y2ud7on5.International registered report identifier (irrid)RR2-10.1186/s12891-019-2801-z.

Project description:BackgroundInternet-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.ObjectiveThe 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.MethodsExploratory 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.ResultsParticipants 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.ConclusionsPeople 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 registrationAustralian 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).

Project description:The purpose of this study was to determine the efficacy of a home-based kinesthesia, balance and agility (KBA) exercise program to improve symptoms among persons age ? 50 years with knee osteoarthritis (OA). Forty-four persons were randomly assigned to 8-weeks, 3 times per week KBA, resistance training (RT), KBA + RT, or Control. KBA utilized walking agility exercises and single-leg static and dynamic balancing. RT used elastic resistance bands for open chain lower extremity exercises. KBA + RT performed selected exercises from each technique. Control applied inert lotion daily. Outcomes included the OA specific WOMAC Index of Pain, Stiffness, and Physical Function (PF), community activity level, exercise self-efficacy, self-report knee stability, and 15m get up & go walk (GUG). Thirty-three participants [70.7 (SD 8.5) years] completed the trial. Analysis of variance comparing baseline, mid-point, and follow-up measures revealed significant (p < 0.05) improvements in WOMAC scores among KBA, RT, KBA + RT, and Control, with no differences between groups. However, Control WOMAC improvements peaked at mid-point, whereas improvement in the exercise conditions continued at 8-weeks. There were no significant changes in community activity level. Only Control improved exercise self-efficacy. Knee stability was improved in RT and Control. GUG improved in RT and KBA+RT. These results indicate that KBA, RT, or a combination of the two administered as home exercise programs are effective in improving symptoms and quality of life among persons with knee OA. Control results indicate a strong placebo effect in the short term. A combination of KBA and RT should be considered as part of the rehabilitation program, but KBA or RT alone may be appropriate for some patients. Studies with more statistical power are needed to confirm or refute these results. Patient presentation, preferences, costs, and convenience should be considered when choosing an exercise rehabilitation approach for persons with knee OA.

Project description:BackgroundKnee 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.MethodsWe 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.DiscussionFindings will provide new information into the potential of SMS to improve longer-term exercise adherence and ultimately enhance exercise outcomes in knee OA.Trial registrationProspectively registered with the Australian New Zealand Clinical Trials Registry. Reference: ACTR N12617001243303 Date/version: August 2019/two.

Project description:BackgroundKnee osteoarthritis (KOA) is common in elderly people, causes pain, loss of physical functioning, and disability. This was a two-arm, superiority, quasi-experimental trial. The aim of this study was to evaluate the effectiveness of a home-based exercise intervention (HBEI) to reduce KOA symptoms and improve the physical functioning of elderly patients.MethodsA total of 171 elderly patients (60 years of age or older) with KOA were recruited from four community centers. Patients from two community centers were randomly assigned to the intervention group (IG) and the other two centers were randomly assigned to the control group (CG). Participants in the IG received a 12-week HBEI (including four 2-h sessions supervised by a physiotherapist and fortnightly telephone support) combined with health education, while patients in the CG only received health education. The participants and physiotherapists were aware of the group assignment and alternative treatment components, but the study's hypotheses were not disclosed to the participants. Pain intensity, joint stiffness, lower-limb muscle strength, balance, mobility, and quality of life were measured before and after the intervention by the same blinded assessor.ResultsA total of 171 patients (IG: n = 84, CG: n = 87) were enrolled. Data were obtained from 141 patients with an average age of 68 (range, 60-86 years) who completed the 12-week study (IG: n = 71, CG: n = 70). No significant group differences were found in any outcome measures at baseline. At week 12, the pretest/posttest changes 3significant between-group differences in decreases in pain intensity (- 1.60 (CI, - 2.75 to - 0.58)) and stiffness (- 0.79 (CI, - 1.37 to - 0.21)), with the IG exhibiting significantly larger improvements on both measures than the CG. The IG also showed significantly greater improvements on all the secondary outcomes than the CG did.ConclusionsHBEI may be effective for relieving KOA symptoms, increasing the physical functioning, and improving quality of life in community-dwelling KOA elderly patients. A large randomized controlled trial with long-term follow-up is needed to confirm these findings.Trial registrationChinese Clinical Trails Registry number ChiCTR1800017026 (retrospectively registered). Registered 9 July 2018.

Project description:BackgroundOne in five patients experience chronic pain 1 year after total knee arthroplasty (TKA), highlighting the need for enhanced treatment strategies to improve outcomes. This feasibility trial aimed to optimize the content and delivery of a complex intervention tailored to osteoarthritis (OA) patients at risk of poor outcome after TKA and assess the feasibility of initiating a full-scale multicenter randomized controlled trial (RCT).MethodsPatients scheduled for TKA were included between August 2019 and June 2020 and block-randomized into one of three groups: (a) 12-week exercise therapy and education (ExE) and 10-module internet-delivered cognitive behavioral therapy (iCBT), (b) TKA followed by ExE and iCBT and (c) TKA and standard postoperative care. Outcomes were (i) recruitment and retention rate, (ii) compliance to the intervention and follow-up, (iii) crossover, and (iv) adverse events, reported by descriptive statistics.ResultsFifteen patients were included in the study. Only 1 out of 146 patients screened for eligibility was included during the first 4 months. During the next 3 months, 117 patients were not included since they lived too far from the hospital. To increase the recruitment rate, we made three amendments to the inclusion criteria; (1) at-risk screening of poor TKA outcome was removed as an eligibility criterion, (2) patients across the country could be included in the study and (3) physiotherapists without specific certification were included, receiving thorough information and support. No patients withdrew from the study or crossed over to surgery during the first year. Nine out of 10 patients completed the ExE program and six out of 10 completed the iCBT program. Fourteen out of 15 patients completed the 1-year follow-up. One minor adverse event was registered.ConclusionsExcept for recruitment and compliance to iCBT, feasibility was demonstrated. The initial recruitment process was challenging, and necessary changes were made to increase the recruitment rate. The findings informed how a definitive RCT should be undertaken to test the effectiveness of the complex intervention.Trial registrationThe MultiKnee RCT, including the feasibility study, is pre-registered at ClinicalTrials.gov: NCT03771430 11/12/2018.

Dataset Information

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.

Publications

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.

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