The physical activity paradox revisited: a prospective study on compositional accelerometer data and long-term sickness absence

Background The 'physical activity paradox' advocates that leisure physical activity (PA) promotes health while high occupational PA impairs health. However, this paradox can be explained by methodological limitations of the previous studies-self-reported PA measures, insufficient adjustment for socioeconomic confounding or not addressing the compositional nature of PA. Therefore, this study investigated if we still observe the PA paradox in relation to long-term sick absence (LTSA) after adjusting for the abovementioned limitations. Methods Time spent on moderate-to-vigorous physical activity (MVPA) and remaining physical behaviors (sedentary behavior, standing, light PA and time in bed) at work and in leisure was measured for 929 workers using thigh accelerometry and expressed as isometric log-ratios (ilrs). LTSA was register-based first event of >= 6 consecutive weeks of sickness absence during 4-year follow-up. The association betweenilrsand LTSA was analyzed using a Cox proportional hazards model adjusted for remaining physical behaviors and potential confounders, then separately adjusting for and stratifying by education and type of work. Results During the follow-up, 21% of the workers experienced LTSA. In leisure, more relative MVPA time was negatively associated with LTSA (20% lower risk with 20 min more MVPA,p = 0.02). At work, more relative MVPA time was positively associated with LTSA (15% higher risk with 20 min more MVPA,p = 0.02). Results remained unchanged when further adjusted for or stratified by education and type of work. Conclusion These findings provide further support to the 'PA paradox'

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

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

Effectiveness of app-delivered, tailored self-management support for adults with lower back pain–related disability

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: NCT0379828

Operationalizing a model to quantify implementation of a multi-component intervention in a stepped-wedge trial

Abstract Background It is challenging to interpret the results of multifaceted interventions due to complex program theories that are difficult to measure in a quantifiable manner. The aims of this paper were, first, to develop a model for a comprehensive quantitative implementation evaluation and, second, to operationalize it in the process evaluation of the stepped-wedge cluster randomized controlled trial: “Prevention of low back pain and its consequences among nurses’ aides in elderly care” to investigate if implementation differed across intervention components, steps, and settings (workplaces). Methods Operationalization of a quantifiable measure of implementation requires three steps: (1) development of a program logic and intervention protocol, (2) description of a complete and acceptable delivery of the intervention, and (3) description of what determines the receipt of the intervention. Program logic from a previously developed multifaceted stepped-wedge intervention was used. The optimal delivery of the intervention was defined as the deliverers’ full understanding and following of the intervention protocol and that they performed their best and contributed to the participants’ attention and motivation (fidelity). The optimal receipt of the intervention was defined as participants being fully present at all intervention activities (participation), being motivated and satisfied, and having a good social support (responsiveness). Measurements of the fidelity, participation, and responsiveness were obtained from logbooks and questionnaires. Fidelity was multiplied by participation to measure exposure of the intervention to the individual. The implementation was determined from optimal delivery and optimal receipt on a scale from 0 (no implementation) to 100 (full implementation) on individual and organizational level. Results Out of 753 sessions, 95% were delivered. The sessions were delivered with 91% success (fidelity) across the organization. Average participation, fidelity, exposure, and responsiveness were 50, 93, 48, and 89% across all participants. The implementation of the intervention was uniform across steps (p = 0.252) and workplaces (p = 0.125) but not for intervention components (p = 0.000). However, participation, fidelity, exposure, and responsiveness varied between workplaces. Conclusions This study developed a quantifiable implementation evaluation measuring participation, fidelity, exposure, and responsiveness. The quantifiable implementation evaluation was suitable for comparing implementation across steps, components, and settings and can be applied in the analyses on the impact of implementation of complex interventions

Does occupational forward bending of the back increase long-term sickness absence risk? A 4-year prospective register-based study using device-measured compositional data analysis

Objective Forward bending of the back is common in many jobs and a risk factor for sickness absence. However, this knowledge is based on self-reported forward bending that is generally imprecise. Thus, we aimed to investigate the dose-response relation between device-measured forward bending at work and prospective register-based risk of long-term sickness absence (LTSA). Methods At baseline, 944 workers (93% from blue-collar jobs) wore accelerometers on their upper back and thigh over 1-6 workdays to measure worktime with forward bending (>30 degrees and >60 degrees) and body positions. The first event of LTSA (>= 6 consecutive weeks) over a 4-year follow-up were retrieved from a national register. Compositional Cox proportional hazard analyses were used to model the association between worktime with forward bending of the back in an upright body position and LTSA adjusted for age, sex, body mass index (BMI), occupational lifting/carrying, type of work, and, in an additional step, for leisure time physical activity (PA) on workdays. Results During a mean worktime of 457 minutes/day, the workers on average spent 40 and 10 minutes on forward bending >30 degrees and >60 degrees in the upright position, respectively. Five more minutes forward bending >30 degrees and >60 degrees at work were associated with a 4% [95% confidence interval (CI) 1.01-1.07] and 8% (95% CI 1.01-1.16) higher LTSA risk, respectively. Adjustment for leisure-time PA did not influence the results. Conclusion We found a dose-response association between device-measured forward bending of the back and prospective LTSA risk. This knowledge can be integrated into available feasible methods to measure forward bending of the back for improved workplace risk assessment and prevention