Development and feasibility of a conceptual model for planning individualised physical exercise training (IPET) for older adults: a cross-sectional study.

OBJECTIVE: Older adults constitute a heterogeneous group, and the focus of the individual physical exercise is often subject to the reasoning and experience of health professionals or exercise physiologists who prescribe them. Thus, this is the first effort to explicitly conceptualise the planning of individualised physical exercise training (IPET) for older adults in an outpatient setting and investigate individual exercise preferences. DESIGN: The concept of IPET was developed by researchers, exercise physiologists and health professionals from a real-life outpatient setting using an iterative approach. Health indicators assessing aerobic capacity, strength, balance and musculoskeletal pain/discomfort sites form the basis of physical exercise recommendations. A cross-sectional study was conducted to assess the basis of implementing IPET. SETTING: Outpatient setting. PARTICIPANTS: We included 115 older adults (70 females) from an outpatient setting with a median age of 74 years. OUTCOME MEASURES: Health indicators assessing aerobic capacity, strength, balance and musculoskeletal pain/discomfort sites were collected and informed the concept of IPET that structures exercise programmes based on the individual citizen's needs and physical exercise preferences. Exceeding a health indicator cut-point results in exercise content mitigating the risk associated with the health indicator. RESULTS: We included 115 older adults (70 females) from an outpatient setting median age of 74 years. Approximately two-thirds of participants exceeded at least one health indicator cut-point for aerobic training. One-third of the participants exceeded the cut-point for upper extremity strength, and almost all participants >99% exceeded the cut-point for lower extremity strength. Approximately two-thirds of the participants exceeded the cut-point for functional/balance training. The most prevalent site of musculoskeletal pain was the lower extremities. Eight of 20 training combinations were used, clustering the 115 participants primarily in three main training combinations. DISCUSSION: This study shows that older adults vary in physical functioning, indicating that exercise preferences and rehabilitation needs are individual. TRIAL REGISTRATION NUMBER: NCT04862481.

Interest in mHealth Among Patients With Low Back Pain: Cross-Sectional Study.

BACKGROUND: Digitally supported self-management tailored to an individual's need, in addition to usual care, may reduce pain-related disability compared to usual care alone, and patients with low back pain (LBP) using mobile health (mHealth) solutions express positive experiences. Hence, implementing mHealth solutions designed to support self-management is desirable from a clinical and patient perspective. Easily accessible mHealth solutions that can support the self-management of patients with LBP are available, but interest may be subgroup specific. Understanding the characteristics and preferences of patients with LBP labeled as interested may help to reach relevant LBP patient groups and inform the development and implementation of effective interventions with mHealth for patients with LBP. OBJECTIVE: This study aims to explore the proportion of patients with LBP labeled as interested in testing an mHealth solution designed to support self-management in addition to usual care and to assess how these patients differ from those who were labeled as not interested. METHODS: This exploratory cross-sectional study analyzed demographic and patient-reported outcomes from the SpineData registry, a Danish registry of patients with LBP in an outpatient setting. Between February and December 2019, the SpineData registry was used to assess the preliminary eligibility of patients for a clinical trial (selfBACK). Patients were labeled as interested or uninterested depending on if they responded to an invitation to be tested for eligibility for the trial Outcomes were selected from the International Classification of Functioning core set of LBP using a clinical approach. Associations were assessed in a backward selection process, and the proportion of variance explained was assessed with pseudo-R2 statistic. RESULTS: This study included 843 patients, with 181 (21%) individuals labeled as interested in participating in the selfBACK trial. Notably, the cohort labeled as interested differed from their uninterested counterparts in two key aspects: age (36-65 years: 116/181, 64.1% vs 347/662, 52.4%; P=.003) and smoking status (smokers: 22/181, 12.5% vs 174/662, 26.6%; P<.001). Those aged 36-65 years had higher odds of being labeled as interested compared to individuals aged 18-35 years (odds ratio [OR] 0.43, 95% CI 0.26-0.71) and those 65 years or older (OR 0.77, 95% CI 0.53-1.15). Nevertheless, age accounted for only a modest proportion of variance (R2=0.014). Smokers demonstrated lower odds of being labeled as interested (OR 0.39, 95% CI 0.24-0.64), with smoking status explaining a similarly small proportion of variance (R2=0.019). Collectively, age and smoking status accounted for 3.3% of the variance. CONCLUSIONS: Our investigation revealed that 181 (21%) individuals with LBP invited to participate in the mHealth solution trial for self-management expressed interest. Generally, the characteristics of those labeled as interested and uninterested were comparable. Of note, patients aged 36-65 years had a higher frequency of being labeled as interested compared to their younger and older counterparts.

The Role of Pain Duration and Pain Intensity on the Effectiveness of App-Delivered Self-Management for Low Back Pain (selfBACK): Secondary Analysis of a Randomized Controlled Trial.

Background: Clinical guidelines for nonspecific low back pain (LBP) recommend self-management tailored to individual needs and capabilities as a first-line treatment. Mobile health solutions are a promising method for delivering tailored self-management interventions to patients with nonspecific LBP. However, it is not clear if the effectiveness of such self-management interventions depends on patients' initial pain characteristics. High pain intensity and long-term symptoms of LBP have been associated with an unfavorable prognosis, and current best evidence indicates that long-term LBP (lasting more than 3 months) requires a more extensive treatment approach compared to more acute LBP. The artificial intelligence-based selfBACK app supports tailored and evidence-based self-management of nonspecific LBP. In a recent randomized controlled trial, we showed that individuals who received the selfBACK app in addition to usual care had lower LBP-related disability at the 3-month follow-up compared to those who received usual care only. This effect was sustained at 6 and 9 months. Objective: This study aims to explore if the baseline duration and intensity of LBP influence the effectiveness of the selfBACK intervention in a secondary analysis of the selfBACK randomized controlled trial. Methods: In the selfBACK trial, 461 adults (18 years or older) who sought care for nonspecific LBP in primary care or at an outpatient spine clinic were randomized to receive the selfBACK intervention adjunct to usual care (n=232) or usual care alone (n=229). In this secondary analysis, the participants were stratified according to the duration of the current LBP episode at baseline (≤12 weeks vs >12 weeks) or baseline LBP intensity (≤5 points vs >5 points) measured by a 0-10 numeric rating scale. The outcomes were LBP-related disability measured by the Roland-Morris Disability Questionnaire (0- to 24-point scale), average LBP intensity, pain self-efficacy, and global perceived effect. To assess whether the duration and intensity of LBP influenced the effect of selfBACK, we estimated the difference in treatment effect between the strata at the 3- and 9-month follow-ups with a 95% CI. Results: Overall, there was no difference in effect for patients with different durations or intensities of LBP at either the 3- or 9-month follow-ups. However, there was suggestive evidence that the effect of the selfBACK intervention on LBP-related disability at the 3-month follow-up was largely confined to people with the highest versus the lowest LBP intensity (mean difference between the intervention and control group -1.8, 95% CI -3.0 to -0.7 vs 0.2, 95% CI -1.1 to 0.7), but this was not sustained at the 9-month follow-up. Conclusions: The results suggest that the intensity and duration of LBP have negligible influence on the effectiveness of the selfBACK intervention on LBP-related disability, average LBP intensity, pain self-efficacy, and global perceived effect.

Do age, gender, and education modify the effectiveness of app-delivered and tailored self-management support among adults with low back pain?-Secondary analysis of the selfBACK randomised controlled trial.

selfBACK is an artificial intelligence based self-management app for low back pain (LBP) recently reported to reduce LBP-related disability. The aim of this study was to examine if age, gender, or education modify the effectiveness of the selfBACK intervention using secondary analysis of the selfBACK randomized controlled trial. Persons seeking care for LBP were recruited from primary care in Denmark and Norway and an outpatient clinic (Denmark). The intervention group (n = 232) received the selfBACK app adjunct to usual care. The control group (n = 229) received usual care only. Analyses were stratified by age (18-34, 35-64, ≥65 years), gender (male, female), and education (≤12, >12 years) to investigate differences in effect at three and nine months follow-up on LBP-related disability (Roland-Morris Disability Questionnaire [RMDQ]), LBP intensity and pain self-efficacy. Overall, there was no effect modification for any of the sociodemographic factors. However, data on LBP-related disability suggest that the effect of the intervention was somewhat more beneficial in older than in younger participants. The difference between the intervention and control group due to interaction was 2.6 (95% CI: 0.4 to 4.9) RMDQ points for those aged ≥65 years as compared to those aged 35-64 years. In conclusion, age, gender, or education did not influence the effect of the selfBACK intervention on LBP-related disability. However, older participants may have an additional long-term positive effect compared to younger participants. Trial registration: ClinicalTrials.gov Identifier: NCT03798288.

Internal consistency and construct validity of the Short Musculoskeletal Function Assessment (SMFA) in older adults.

OBJECTIVE: The primary objectives of this study were to 1) investigate the internal consistency 2) and construct validity of the Short Musculoskeletal Function Assessment Questionnaire (SMFA) in older adults commencing physical rehabilitation in an outpatient setting. METHODS: This cross-sectional study recruited older adults who had commenced physical rehabilitation in an outpatient setting. The SMFA consists of two indices: 1) dysfunction capturing the impact of musculoskeletal disorders on physical limitations, and 2) bothering capturing how the individual is emotionally affected by their disorder. SMFA holds four categories: 'mobility', 'daily activities', 'emotional status', and 'function of the arm and hand'. Participants answered the SMFA alongside other patient-reported questionnaires (such as the 36-Item Short Form Survey, SF-36) and similar) and objectively measured muscle strength for the upper and lower body and functional capacity. RESULTS: We included 115 older adults with a median age of 74 years (IQR 9). Adequate internal consistency was seen with Cronbach's alpha values of 0.90-0.94 for the SMFA indices and 0.77-0.91 for the SMFA categories. The strongest correlations between the SMFA indices were observed with the SF-36 physical component summary (SMFA-Dysfunction r = 0.74, p < 0.05, SMFA-Bother r = 0.72, p < 0.05). Only fair correlations were found between SMFA index scores and clinical outcome measures. DISCUSSION: This study demonstrated that the SMFA has adequate internal consistency and construct validity for self-reported health status in older adults, especially when considering components covering physical health status. However, we only observed fair correlations between SMFA and clinical outcome measures, indicating that SMFA does not adequately capture muscle strength and functional capacity.

Intelligent Physical Exercise Training (IPET) in the offshore wind industry: a feasibility study with an adjusted conceptual model.

BACKGROUND: Good physical health and capacity is a requirement for offshore wind service technicians (WTs) who have substantial physical work demands and are exposed to numerous health hazards. Workplace physical exercise has shown promise for improving physical health and work ability among various occupational groups. Therefore, we aimed to assess the feasibility and preliminary efficacy of Intelligent Physical Exercise Training (IPET) among WTs in the offshore wind industry. METHODS: A within-subject design was used to assess the feasibility and preliminary efficacy of IPET (one hour/week individualized exercise during working hours). The intervention period was 12 weeks, with the first eight weeks performed on site as supervised or partly supervised exercise during work hours and the last four weeks planned as home-administered exercise after the seasonal offshore service period. Three assessments, T1 (six months prior to intervention start), T2 (start of intervention) and T3 (end of intervention), of physical health and capacity (self-reported and objective measurements) were conducted and the period between T1 and T2 served as a within-subject control period. Primary outcome was feasibility measured as compliance, adherence, adverse events, and participant acceptability. Descriptive statistics were used to present feasibility outcomes. Preliminary efficacy was reported as mean differences with 95% confidence intervals for health and physical capacity outcomes between T1 and T2, between T2 and T3 and between T1 and T3. RESULTS: All WTs at the included wind farm (n=24, age: 40 years (SD±8)) participated in the study. No serious adverse events were reported. Compliance and adherence of 95 and 80% respectively, were reached in the eight-week supervised part, but were lower when exercise was home-administered (<20%). Acceptability was high for the supervised part, with 83% indicating that the exercise program worked well and 100% that exercise should be implemented as an integrated part of the working structure. Changes in physical capacity and health indicators, such as VO2max (ml O2/kg/min) at T1 (38.6 (SD±7.2)), T2 (44.1 (SD±9)) and T3 (45.8 (SD±6.5)), may indicate seasonal fluctuations as well as improvements from the intervention. CONCLUSION: On-site Intelligent Physical Exercise Training during working hours was feasible and well received among WTs in the offshore wind industry. The proceeding of larger-scale evaluation and implementation is therefore recommended. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT04995718 ). Retrospectively registered on August 6, 2021.

The objectively measured physical work demands and physical capacity of offshore wind technicians: An observational field study.

We aimed to assess the physical capacity and physical work demands of wind service technicians (WT) in different field conditions (onshore and offshore workdays). We recruited 27 male WTs (mean age of 31 years (SD: ±7), VO2max of 46 mL O2/kg/min (SD: ±7)) and assessed their physical work demands for a total of 110 workdays using heart rate monitors and accelerometers at five body placements. On average, each day, sitting was the most recorded activity (43%), followed by standing (19%), lying (13%) moving (9%), walking (8%) and high intensity physical activities (1%). Additionally, 1 minute was spent on vertical climbing, 20 minutes on work with forward bent trunk, 13 minutes on work with elevated arms and 6 minutes kneeling. The average cardiovascular load was 22% and 4 minutes per day were spent at high cardiovascular intensities. We found significantly higher demands on offshore compared with onshore workdays.

Using Intervention Mapping to Develop a Decision Support System-Based Smartphone App (selfBACK) to Support Self-management of Nonspecific Low Back Pain: Development and Usability Study.

BACKGROUND: International guidelines consistently endorse the promotion of self-management for people with low back pain (LBP); however, implementation of these guidelines remains a challenge. Digital health interventions, such as those that can be provided by smartphone apps, have been proposed as a promising mode of supporting self-management in people with chronic conditions, including LBP. However, the evidence base for digital health interventions to support self-management of LBP is weak, and detailed descriptions and documentation of the interventions are lacking. Structured intervention mapping (IM) constitutes a 6-step process that can be used to guide the development of complex interventions. OBJECTIVE: The aim of this paper is to describe the IM process for designing and creating an app-based intervention designed to support self-management of nonspecific LBP to reduce pain-related disability. METHODS: The first 5 steps of the IM process were systematically applied. The core processes included literature reviews, brainstorming and group discussions, and the inclusion of stakeholders and representatives from the target population. Over a period of >2 years, the intervention content and the technical features of delivery were created, tested, and revised through user tests, feasibility studies, and a pilot study. RESULTS: A behavioral outcome was identified as a proxy for reaching the overall program goal, that is, increased use of evidence-based self-management strategies. Physical exercises, education, and physical activity were the main components of the self-management intervention and were designed and produced to be delivered via a smartphone app. All intervention content was theoretically underpinned by the behavior change theory and the normalization process theory. CONCLUSIONS: We describe a detailed example of the application of the IM approach for the development of a theory-driven, complex, and digital intervention designed to support self-management of LBP. This description provides transparency in the developmental process of the intervention and can be a possible blueprint for designing and creating future digital health interventions for self-management.

Effectiveness of App-Delivered, Tailored Self-management Support for Adults With Lower Back Pain-Related Disability: A selfBACK Randomized Clinical Trial.

Importance: Lower back pain (LBP) is a prevalent and challenging condition in primary care. The effectiveness of an individually tailored self-management support tool delivered via a smartphone app has not been rigorously tested. Objective: To investigate the effectiveness of selfBACK, an evidence-based, individually tailored self-management support system delivered through an app as an adjunct to usual care for adults with LBP-related disability. Design, Setting, and Participants: This randomized clinical trial with an intention-to-treat data analysis enrolled eligible individuals who sought care for LBP in a primary care or an outpatient spine clinic in Denmark and Norway from March 8 to December 14, 2019. Participants were 18 years or older, had nonspecific LBP, scored 6 points or higher on the Roland-Morris Disability Questionnaire (RMDQ), and had a smartphone and access to email. Interventions: The selfBACK app provided weekly recommendations for physical activity, strength and flexibility exercises, and daily educational messages. Self-management recommendations were tailored to participant characteristics and symptoms. Usual care included advice or treatment offered to participants by their clinician. Main Outcomes and Measures: Primary outcome was the mean difference in RMDQ scores between the intervention group and control group at 3 months. Secondary outcomes included average and worst LBP intensity levels in the preceding week as measured on the numerical rating scale, ability to cope as assessed with the Pain Self-Efficacy Questionnaire, fear-avoidance belief as assessed by the Fear-Avoidance Beliefs Questionnaire, cognitive and emotional representations of illness as assessed by the Brief Illness Perception Questionnaire, health-related quality of life as assessed by the EuroQol-5 Dimension questionnaire, physical activity level as assessed by the Saltin-Grimby Physical Activity Level Scale, and overall improvement as assessed by the Global Perceived Effect scale. Outcomes were measured at baseline, 6 weeks, 3 months, 6 months, and 9 months. Results: A total of 461 participants were included in the analysis; the population had a mean [SD] age of 47.5 [14.7] years and included 255 women (55%). Of these participants, 232 were randomized to the intervention group and 229 to the control group. By the 3-month follow-up, 399 participants (87%) had completed the trial. The adjusted mean difference in RMDQ score between the 2 groups at 3 months was 0.79 (95% CI, 0.06-1.51; P = .03), favoring the selfBACK intervention. The percentage of participants who reported a score improvement of at least 4 points on the RMDQ was 52% in the intervention group vs 39% in the control group (adjusted odds ratio, 1.76; 95% CI, 1.15-2.70; P = .01). Conclusions and Relevance: Among adults who sought care for LBP in a primary care or an outpatient spine clinic, those who used the selfBACK system as an adjunct to usual care had reduced pain-related disability at 3 months. The improvement in pain-related disability was small and of uncertain clinical significance. Process evaluation may provide insights into refining the selfBACK app to increase its effectiveness. Trial Registration: ClinicalTrials.gov Identifier: NCT03798288.

Barriers to, and Facilitators of, Exercising in Fitness Centres among Adults with and without Physical Disabilities: A Scoping Review.

Fitness centres are an obvious arena for performing physical activity for the general population but representation of adults with physical disabilities (AwPD) is lacking. To increase possibilities for AwPD to exercise in fitness centres together with adults without physical disabilities (AwoPD), the aim of this study was to identify, synthesise, and compare barriers to, and facilitators of, exercising in fitness centres for each group. A scoping review was conducted and data extraction of the barriers and facilitators was performed independently by two researchers on six categories of contextual factors based on the framework of Di Blasi: (1) The fitness centre setting; (2) The fitness centre user characteristics; (3) The fitness instructor/staff characteristics; (4) The fitness centre user-instructor/management relationship; and (5) The fitness/exercise characteristics. An extra category, (6) Other relationships, was added. The PRISMA Extension for Scoping Reviews was used for reporting. Of the 102 included papers, only 26 (25%) of the papers were on AwPD, which focused mainly on physical barriers (category 1: inaccessible settings). In contrast, the remaining 76 papers involving AwoPD focused primarily on facilitators (category 2: motivational factors and exercising effects). In categories 3-6, the two groups had similar results, as both groups preferred skilled instructors, a welcoming and comfortable fitness centre environment, an ability to exercise at their preferred type and level, and good social connections. Since most data were based on AwoPD, more studies on actual experiences from AwPD are needed, to reveal the facilitators/motivational factors for fitness centre use.

Fitness for all: how do non-disabled people respond to inclusive fitness centres?

BACKGROUND: Representation of people with disabilities in fitness centres is lacking, despite initiatives to promote inclusion mainly in the UK and USA. Success creating these inclusive spaces is mixed and few were crafted taking into account attitudes and biases of non-disabled co-members. Inclusive fitness centres have not gained much attention in Denmark, and the campaign 'Fitness for All - fitness for people with physical disabilities' was initiated. The aim of this study was shaped by two key questions; 1) what is the ideal fitness space from the perception of non-disabled fitness users? and 2) how might their dis/ableist attitudes negate inclusion in three future pilot inclusive fitness centres across Denmark? METHOD: Three focus groups involving 5-7 (total n = 18) adult non-disabled participants were conducted. Aged ranged between 19 and 75 years, both men and women were involved, with fitness centre experiences ranging from 0 to 20+ years. Interviews were transcribed and analysed using Malterud's four-step method of systematic text condensation. RESULTS: Of most importance was a pleasant atmosphere which should make them feel welcome and comfortable. Good social relations within the space were also highly valued. Participants welcomed people with physical disabilities but predicted many challenges with an inclusive fitness centre and expressed unconscious ableist attitudes. CONCLUSION: The current study adds essential knowledge regarding how non-disabled people perceive the ideal inclusive fitness centre. A welcoming and inviting atmosphere is essential whereas social skills, ableism, ignorance, and preconceptions are important barriers that may hinder inclusion of participants with disabilities in inclusive fitness centres.

Barriers and facilitators to patient uptake and utilisation of digital interventions for the self-management of low back pain: a systematic review of qualitative studies.

OBJECTIVES: Low back pain (LBP) is a leading contributor to disability globally. Self-management is a core component of LBP management. We aimed to synthesise published qualitative literature concerning digital health interventions (DHIs) to support LBP self-management to: (1) determine engagement strategies, (2) identify barriers and facilitators affecting patient uptake/utilisation and (3) develop a preliminary conceptual model of barriers and facilitators to uptake/utilisation. DESIGN: Systematic review following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. DATA SOURCES: MEDLINE, Embase, CINAHL, PsycINFO, Cochrane Library, DoPHER, TRoPHI, Web of Science and OT Seeker, from January 2000 to December 2018, using the concepts: LBP, DHI and self-management. ELIGIBILITY CRITERIA: Peer-reviewed qualitative study (or component) examining engagement with, or barriers and/or facilitators to the uptake/utilisation of an interactive DHI for self-management of LBP in adults (community, primary or secondary care settings). DATA EXTRACTION AND SYNTHESIS: Standardised data extraction form was completed. COREQ (Consolidated criteria for Reporting Qualitative research) checklist was used to assess methodology. Data was synthesised narratively for engagement strategies, thematically for barriers/facilitators to uptake/utilisation and normalisation process theory was applied to produce a conceptual model. RESULTS: We identified 14 191 citations, of which 105 full-text articles were screened, and five full-text articles from four studies included. These were from community and primary care contexts in Europe and the USA, and involved 56 adults with LBP and 19 healthcare professionals. There was a lack of consideration on how to sustain engagement with DHIs. Examination of barriers and facilitators for uptake/utilisation identified four major themes: IT (information technology) usability-accessibility; quality-quantity of content; tailoring-personalisation; and motivation-support. These themes informed the development of a preliminary conceptual model for uptake/utilisation of a DHI for LBP self-management. CONCLUSIONS: We highlight key barriers and facilitators that should be considered when designing DHIs for LBP self-management. Our findings are in keeping with reviews of DHIs for other long-term conditions, implying these findings may not be condition specific. SYSTEMATIC REVIEW REGISTRATION: A protocol for this systematic review was registered with https://www.crd.york.ac.uk/PROSPERO/ (CRD42016051182) on 10 November 2016. https://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42016051182.

Individualised physical exercise training and enhanced protein intake in older citizens during municipality-based rehabilitation: protocol for a randomised controlled trial.

INTRODUCTION: Successful rehabilitation of the growing number of older citizens receiving healthcare services can lead to preservation of functional independence and improvement in quality of life. Adequate intake of dietary protein and physical training are key factors in counteracting the age-related decline in strength performance and physical function. However, during rehabilitation, many older people/persons have insufficient protein intake, and difficulties in performing exercise training with sufficient intensity and volume. The primary aim of this trial is to investigate if individualised physical exercise training programmes combined with increased protein intake (IPET+P) can improve measures on all International Classification of Functioning, Disability and Health levels, such as strength, gait speed and health-related quality of life, when compared with care as usual in municipality-based rehabilitation alone (usual care, UC) or care as usual in combination with increased protein intake (UC+P). Further, the trial investigates whether UC+P will potentiate more significant improvements in outcome measures than UC. METHODS AND ANALYSIS: The trial is a three-armed multicentre, block-randomised controlled trial consisting of a 12-week intervention period with a 1-year follow-up. Citizens above 65 years referred to rehabilitation in the municipality without restricting comorbidities are eligible. Participants are randomised to either a UC group, a UC group with protein supplementation receiving 27.5 g protein/day (UC+P), or an IPET+P supplementation of 27.5 g protein/day. The Short Musculoskeletal Function Assessment questionnaire is the primary outcome. ETHICS AND DISSEMINATION: Approvals from The Ethics Committee in Region Zealand, Denmark (SJ-758), and the General Data Protection Regulation at the University of Southern Denmark, Odense (10.330) have been obtained. TRIAL REGISTRATION NUMBER: NCT04091308.

App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation.

BACKGROUND: Implementation and process evaluation is vital for understanding how interventions function in different settings, including if and why interventions have different effects or do not work at all. OBJECTIVE: This paper presents the protocol for an implementation and process evaluation embedded in a multicenter randomized controlled trial conducted in Denmark and Norway (the selfBACK project). selfBACK is a data-driven decision support system that provides participants with weekly self-management plans for low back pain. These plans are delivered through a smartphone app and tailored to individual participants by using case-based reasoning methodology. In the trial, we compare selfBACK in addition to usual care with usual care alone. METHODS: The aim of this study is to conduct a convergent mixed-methods implementation and process evaluation of the selfBACK app by following the reach, effectiveness, adoption, implementation, and maintenance framework. We will evaluate the process of implementing selfBACK and investigate how participants use the intervention in daily life. The evaluation will also cover the reach of the intervention, health care provider willingness to adopt it, and participant satisfaction with the intervention. We will gather quantitative measures by questionnaires and measures of data analytics on app use and perform a qualitative exploration of the implementation using semistructured interviews theoretically informed by normalization process theory. Data collection will be conducted between March 2019 and October 2020. RESULTS: The trial opened for recruitment in February 2019. This mixed-methods implementation and evaluation study is embedded in the randomized controlled trial and will be collecting data from March 2019 to October 2020; dissemination of trial results is planned thereafter. The results from the process evaluation are expected 2021-2022. CONCLUSIONS: This study will provide a detailed understanding of how self-management of low back pain can be improved and how a digital health intervention can be used as an add-on to usual care to support patients to self-manage their low back pain. We will provide knowledge that can be used to explore the possibilities of extending the generic components of the selfBACK system and key drivers that could be of use in other conditions and diseases where self-management is an essential prevention or treatment strategy. TRIAL REGISTRATION: ClinicalTrials.gov NCT03798288; https://www.clinicaltrials.gov/ct2/show/NCT03798288. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/20308.

A digital decision support system (selfBACK) for improved self-management of low back pain: a pilot study with 6-week follow-up.

BACKGROUND: Very few of the publicly available apps directed towards self-management of low back pain (LBP) have been rigorously tested and their theoretical underpinnings seldom described. The selfBACK app was developed in collaboration with end-users and clinicians and its content is supported by best evidence on self-management of LBP. The objectives of this pilot study were to investigate the basis for recruitment and screening procedures for the subsequent randomized controlled trial (RCT), to test the inclusion process in relation to questionnaires and app installation, and finally to investigate the change in primary outcome over time. METHODS: This single-armed pilot study enrolled 51 participants who had sought help for LBP of any duration from primary care (physiotherapy, chiropractic, or general practice) within the past 8 weeks. Participants were screened for eligibility using the PROMIS-Physical-Function-4a questionnaire. Participants were asked to use the selfBACK app for 6 weeks. The app provided weekly tailored self-management plans targeting physical activity, strength and flexibility exercises, and education. The construction of the self-management plans was achieved using case-based reasoning (CBR) methodology to capture and reuse information from previous successful cases. Participants completed the primary outcome pain-related disability (Roland-Morris Disability Questionnaire [RMDQ]) at baseline and 6-week follow-up along with a range of secondary outcomes. Metrics of app use were collected throughout the intervention period. RESULTS: Follow-up data at 6 weeks was obtained for 43 participants. The recruitment procedures were feasible, and the number needed to screen was acceptable (i.e., 1.6:1). The screening questionnaire was altered during the pilot study. The inclusion process, answering questionnaires and app installation, were feasible. The primary outcome (RMDQ) improved from 8.6 (SD 5.1) at baseline to 5.9 (SD 4.0) at 6-week follow-up (change score 1.8, 95% CI 0.7 to 2.9). Participants spent on average 134 min (range 0-889 min) using the app during the 6-week period. CONCLUSION: The recruitment, screening, and inclusion procedures were feasible for the subsequent RCT with a small adjustment. The improvement on the RMDQ from baseline to follow-up was small. Time pattern of app usage varied considerably between the participants. TRIAL REGISTRATION: NCT03697759. Registered on August 10, 2018. https://clinicaltrials.gov/ct2/show/NCT03697759.

An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial.

BACKGROUND: Low back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile apps are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system made available for the user via an app intended to support tailored self-management of nonspecific LBP. OBJECTIVE: The trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with nonspecific LBP. METHODS: This is a single-blinded, randomized controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of plans is achieved by using case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centered intervention based on what has and has not been successful in previous cases. Participants in the RCT are people with LBP who consulted a health care professional in primary care within the preceding 8 weeks. Participants are randomized to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants (175 participants in each arm). Outcomes are collected at baseline, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months. RESULTS: The trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020. CONCLUSIONS: This RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with nonspecific LBP and inform future interventions for other painful musculoskeletal conditions. TRIAL REGISTRATION: ClinicalTrial.gov NCT03798288; https://clinicaltrials.gov/ct2/show/NCT03798288. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14720.

Exploring the effect of space and place on response to exercise therapy for knee and hip pain--a protocol for a double-blind randomised controlled clinical trial: the CONEX trial.

INTRODUCTION: Context effects are described as effects of a given treatment, not directly caused by the treatment itself, but rather caused by the context in which treatment is delivered. Exercise is a recommended core treatment in clinical guidelines for musculoskeletal disorders. Although moderately effective overall, variation is seen in size of response to exercise across randomised controlled trial (RCT) studies. Part of this variation may be related to the fact that exercise interventions are performed in different physical environments, which may affect participants differently. The study aims to investigate the effect of exercising in a contextually enhanced physical environment for 8 weeks in people with knee or hip pain. METHODS AND ANALYSIS: The study is a double-blind RCT. Eligible participants are 35 years or older with persisting knee and/or hip pain for 3 months. Participants are randomised to one of three groups: (1) exercise in a contextually enhanced environment, (2) exercise in a standard environment and (3) waiting list. The contextually enhanced environment is located in a newly built facility, has large windows providing abundant daylight and overlooks a recreational park. The standard environment is in a basement, has artificial lighting and is marked by years of use; that is, resembling many clinical environments. The primary outcome is the participant's global perceived effect rated on a seven-point Likert scale after 8 weeks exercise. Patient-reported and objective secondary outcomes are included. ETHICS AND DISSEMINATION: The Regional Scientific Ethical Committee for Southern Denmark has approved the study. Study findings will be disseminated in peer-reviewed publications and presented at national and international conferences. TRIAL REGISTRATION NUMBER: NCT02043613.

Vibratory perception threshold in young and middle-aged patients at high risk of knee osteoarthritis compared to controls.

OBJECTIVE: Vibratory perception threshold (VPT) is impaired in patients with knee osteoarthritis (OA). It is, however, not known if sensory deficits precede or follow as a consequence of OA. The aim of this study was to investigate VPT in 2 independent groups of patients with high risk of future OA (young anterior cruciate ligament [ACL]-injured patients and middle-aged meniscectomized patients) and compare them to age-matched controls. METHODS: VPT was assessed at the medial malleolus (MM) and medial femoral condyle (MFC) in 2 independent groups of patients and matched controls: ACL-injured patients (n = 39, mean ± SD age 24.0 ± 5.2 years, mean ± SD BMI 24.0 ± 2.9 kg/m(2) , mean ± SD time since injury 21.9 ± 21.6 months) and controls (n = 28, mean ± SD age 25.6 ± 4.4 years, mean ± SD BMI 23.6 ± 2.2 kg/m(2) ), and meniscectomized patients (n = 22, mean ± SD age 49.6 ± 4.8 years, mean ± SD BMI 24.7 ± 2.7 kg/m(2) , mean ± SD time since surgery 49.6 ± 5.0 months) and controls (n = 25, mean ± SD age 49.4 ± 5.2 years, mean ± SD BMI 25.2 ± 4.9 kg/m(2) ). RESULTS: ACL-injured patients had a better VPT than controls at the MM (P = 0.030), which persisted after adjusting for age and sex (P = 0.034). At the MFC, there was a similar trend in favor of ACL injured patients (unadjusted P = 0.093, adjusted P = 0.122). No differences were seen in VPT at the MM between meniscectomized patients and controls, whereas there was a tendency for better VPT in meniscectomized patients at the MFC (unadjusted P = 0.085, adjusted P = 0.092). CONCLUSION: Impaired vibratory sensation could not be confirmed in 2 independent groups of patients compared to age-matched controls, suggesting that impaired vibratory sense is not present in knee-injured patients at high risk or in the very early phase of knee OA.