Study design of 'Move More': Development and feasibility of a social-prescribing intervention to increase physical activity among inactive Danes.

AIM: This paper describes the design of the 'Move More' study, which aims to develop and assess the feasibility of a social-prescribing intervention to increase physical activity among physically inactive Danes. BACKGROUND: Physical inactivity constitutes a public-health challenge in Denmark. Social prescribing may be a promising tool to tackle physical inactivity by linking physical activity support from general practitioners with community-based activities in sports clubs, as this may help physically inactive citizens become more physically active. Given the range of stakeholders and behaviours required for social prescribing of physical activity, an intervention that harnesses this approach may constitute a complex intervention. The methods and decisions made in the stages of developing complex interventions are seldom reported. The present study enabled us to describe how co-creation can be used in a pragmatic development process for a complex intervention that considers the needs of stakeholders and the conditions of the delivery context. METHODS: The study is based on the core elements of the development and feasibility phases of the Medical Research Council Framework for Developing and Evaluating Complex Interventions. Additionally, it is informed by a framework for the co-creation and prototyping of public-health interventions, drawing from a scoping review, stakeholder consultations and co-creation workshops. Ultimately, a feasibility study will be conducted to refine the programme theory by introducing the proposed intervention in case studies. PERSPECTIVES: The study will result in a prototype intervention manual and recommendations for implementation of an adapted social-prescribing intervention targeting physical inactivity in Denmark.

The Effects of a Lifestyle Intervention Supported by the InterWalk Smartphone App on Increasing Physical Activity Among Persons With Type 2 Diabetes: Parallel-Group, Randomized Trial.

BACKGROUND: Effective and sustainable implementation of physical activity (PA) in type 2 diabetes (T2D) health care has in general not been successful. Efficacious and contemporary approaches to support PA adherence and adoption are required. OBJECTIVE: The primary objective of this study was to investigate the effectiveness of including an app-based (InterWalk) approach in municipality-based rehabilitation to increase moderate-and-vigorous PA (MVPA) across 52 weeks compared with standard care among individuals with T2D. METHODS: The study was designed as a parallel-group, randomized trial with 52 weeks' intervention and subsequent follow-up for effectiveness (52 weeks from baseline). Participants were recruited between January 2015 and December 2016 and randomly allocated (2:1) into 12 weeks of (1) standard care + InterWalk app-based interval walking training (IWT; IWT group; n=140), or (2) standard care + the standard exercise program (StC group; n=74). Following 12 weeks, the IWT group was encouraged to maintain InterWalk app-based IWT (3 times per week for 30-60 minutes) and the StC group was encouraged to maintain exercise without structured support. Moreover, half of the IWT group (IWTsupport group, n=54) received additional motivational support following the 12-week program until 52-week follow-up. The primary outcome was change in objectively measured MVPA time (minutes/day) from baseline to 52-week follow-up. Key secondary outcomes included changes in self-rated physical and mental health-related quality of life (HRQoL), physical fitness, weight, and waist circumference. RESULTS: Participants had a mean age of 59.6 (SD 10.6) years and 128/214 (59.8%) were men. No changes in MVPA time were observed from baseline to 52-week follow-up in the StC and IWT groups (least squares means [95% CI] 0.6 [-4.6 to 5.8] and -0.2 [-3.8 to 3.3], respectively) and no differences were observed between the groups (mean difference [95% CI] -0.8 [-8.1 to 6.4] minutes/day; P=.82). Physical HRQoL increased by a mean of 4.3 (95% CI 1.8 to 6.9) 12-item Short-Form Health Survey (SF-12) points more in the IWT group compared with the StC group (Benjamini-Hochberg adjusted P=.007) and waist circumference apparently decreased a mean of -2.3 (95% CI -4.1 to -0.4) cm more in the IWT group compared with the StC group but with a Benjamini-Hochberg adjusted P=.06. No between-group differences were observed among the remaining key secondary outcomes. CONCLUSIONS: Among individuals with T2D referred to municipality-based lifestyle programs, randomization to InterWalk app-based IWT did not increase objectively measured MVPA time over 52 weeks compared with standard health care, although apparent benefits were observed for physical HRQoL. TRIAL REGISTRATION: ClinicalTrials.gov NCT02341690; https://clinicaltrials.gov/ct2/show/NCT02341690.

Translation and Cross-Cultural Adaptation of the Exercise Adherence Rating Scale (EARS) into Danish.

The Exercise Adherence Rating Scale (EARS) is a self-administrated questionnaire designed to measure adherence to prescribed home-based exercises in a British population. In a Danish context, no reliable and valid questionnaires are available to measure exercise adherence. This study aimed to translate and cross-culturally adapt the EARS into Danish following international guidelines and to provide insights about construct validity in a Danish population with longstanding hip pain. The EARS was translated and cross-culturally adapted into Danish using a forward-backward method. The understanding and interpretability of the EARS were evaluated with semistructured interviews in 24 patients with longstanding hip pain due to hip dysplasia (22 females; median age 30 (IQR 24-37)). These patients were prescribed home-based exercises. Using Spearman's correlation, construct validity was evaluated by assessing if the Danish version of EARS was correlated with completed exercise sessions and self-reported pain and sport/recreation function. The EARS was translated and cross-culturally adapted into Danish following minor adjustments. The EARS was statistically significantly correlated to completed exercise sessions (p=0.005), self-reported pain (p=0.005), and sport/recreation function (p < 0.03). In patients with longstanding hip pain, the Danish EARS seems suitable to measure adherence to prescribed exercises; however, further evaluation of measurement properties may be needed.

A CHecklist for statistical Assessment of Medical Papers (the CHAMP statement): explanation and elaboration.

Misuse of statistics in medical and sports science research is common and may lead to detrimental consequences to healthcare. Many authors, editors and peer reviewers of medical papers will not have expert knowledge of statistics or may be unconvinced about the importance of applying correct statistics in medical research. Although there are guidelines on reporting statistics in medical papers, a checklist on the more general and commonly seen aspects of statistics to assess when peer-reviewing an article is needed. In this article, we propose a CHecklist for statistical Assessment of Medical Papers (CHAMP) comprising 30 items related to the design and conduct, data analysis, reporting and presentation, and interpretation of a research paper. While CHAMP is primarily aimed at editors and peer reviewers during the statistical assessment of a medical paper, we believe it will serve as a useful reference to improve authors' and readers' practice in their use of statistics in medical research. We strongly encourage editors and peer reviewers to consult CHAMP when assessing manuscripts for potential publication. Authors also may apply CHAMP to ensure the validity of their statistical approach and reporting of medical research, and readers may consider using CHAMP to enhance their statistical assessment of a paper.

Knee Injuries in Normal-Weight, Overweight, and Obese Runners: Does Body Mass Index Matter?

OBJECTIVE: To investigate whether the proportion of running-related knee injuries differed in normal-weight, overweight, and obese runners. DESIGN: Comparative study. METHODS: Data from 4 independent prospective studies were merged (2612 participants). The proportion of running-related knee injuries out of the total number of running-related injuries was calculated for normal-weight, overweight, and obese runners, respectively. The measure of association was absolute difference in proportion of running-related knee injuries with normal-weight runners as the reference group. RESULTS: A total of 571 runners sustained a running-related injury (181 running-related knee injuries and 390 running-related injuries in other anatomical locations). The proportion of running-related knee injuries was 13% lower (95% confidence interval: -22%, -5%; P = .001) among overweight runners compared with normal-weight runners. Similarly, the proportion of running-related knee injuries was 12% lower (95% confidence interval: -23%, -1%; P = .042) among obese runners compared with normal-weight runners. CONCLUSION: Overweight and obese runners had a lower proportion of running-related knee injuries than normal-weight runners. J Orthop Sports Phys Ther 2020;50(7):397-401. doi:10.2519/jospt.2020.9233.

Statement on methods in sport injury research from the 1st METHODS MATTER Meeting, Copenhagen, 2019.

High quality sports injury research can facilitate sports injury prevention and treatment. There is scope to improve how our field applies best practice methods-methods matter (greatly!). The 1st METHODS MATTER Meeting, held in January 2019 in Copenhagen, Denmark, was the forum for an international group of researchers with expertise in research methods to discuss sports injury methods. We discussed important epidemiological and statistical topics within the field of sports injury research. With this opinion document, we provide the main take-home messages that emerged from the meeting.

Methods matter: exploring the 'too much, too soon' theory, part 1: causal questions in sports injury research.

BACKGROUND: It is widely accepted that athletes sustain sports injury if they train 'too much, too soon'. However, not all athletes are built the same; some can tolerate more training than others. It is for this reason that prescribing the same training programme to all athletes to reduce injury risk is not optimal from a coaching perspective. Rather, athletes require individualised training plans. In acknowledgement of athlete diversity, it is therefore essential to ask the right causal research question in studies examining sports injury aetiology. PURPOSE: In this first part of a British Journal of Sports Medicine educational series, we present four different causal research questions related to the 'too much, too soon' theory and critically discuss their relevance to sports injury prevention. CONTENT: If it is true that there is no 'one size fits all' training programme, then we need to consider by how much training can vary depending on individual athlete characteristics. To provide an evidence-base for subgroup-specific recommendations, a stronger emphasis on the following questions is needed: (1) How much training is 'too much' before athletes with different characteristics sustain sports-related injury? and (2) Does the risk of sports injury differ among athletes with a certain characteristic (eg, high experience) compared with athletes with other characteristics (eg, low experience) depending on how much training they perform? CONCLUSION: We recommend that sports injury researchers aiming to examine the 'too much, too soon' theory should carefully consider how they, assisted by coaches, athletes and clinicians, pose their causal research question. In the light of the limitations of population-based prevention that intends to provide all athletes with the same advice, we argue that a stronger emphasis on research questions targeting subgroups of athletes is needed. In doing so, researchers may assist athletes, clinicians and coaches to understand what training advice/programme works best, for whom and under what circumstances.

Improved reporting of overuse injuries and health problems in sport: an update of the Oslo Sport Trauma Research Center questionnaires.

In 2013, the Oslo Sports Trauma Research Center Overuse Injury Questionnaire (OSTRC-O) was developed to record the magnitude, symptoms and consequences of overuse injuries in sport. Shortly afterwards, a modified version of the OSTRC-O was developed to capture all types of injuries and illnesses-The Oslo Sports Trauma Research Center Questionnaire on Health Problems (OSTRC-H). Since then, users from a range of research and clinical environments have identified areas in which these questionnaires may be improved. Therefore, the structure and content of the questionnaires was reviewed by an international panel consisting of the original developers, other user groups and experts in sports epidemiology and applied statistical methodology. Following a review panel meeting in October 2017, several changes were made to the questionnaires, including minor wording alterations, changes to the content of one question and the addition of questionnaire logic. In this paper, we present the updated versions of the questionnaires (OSTRC-O2 and OSTRC-H2), assess the likely impact of the updates on future data collection and discuss practical issues related to application of the questionnaires. We believe this update will improve respondent adherence and improve the quality of collected data.

Randomised controlled trials (RCTs) in sports injury research: authors-please report the compliance with the intervention.

BACKGROUND: In randomised controlled trials (RCTs) of interventions that aim to prevent sports injuries, the intention-to-treat principle is a recommended analysis method and one emphasised in the Consolidated Standards of Reporting Trials (CONSORT) statement that guides quality reporting of such trials. However, an important element of injury prevention trials-compliance with the intervention-is not always well-reported. The purpose of the present educational review was to describe the compliance during follow-up in eight large-scale sports injury trials and address compliance issues that surfaced. Then, we discuss how readers and researchers might consider interpreting results from intention-to-treat analyses depending on the observed compliance with the intervention. METHODS: Data from seven different randomised trials and one experimental study were included in the present educational review. In the trials that used training programme as an intervention, we defined full compliance as having completed the programme within ±10% of the prescribed running distance (ProjectRun21 (PR21), RUNCLEVER, Start 2 Run) or time-spent-running in minutes (Groningen Novice Running (GRONORUN)) for each planned training session. In the trials using running shoes as the intervention, full compliance was defined as wearing the prescribed running shoe in all running sessions the participants completed during follow-up. RESULTS: In the trials that used a running programme intervention, the number of participants who had been fully compliant was 0 of 839 (0%) at 24-week follow-up in RUNCLEVER, 0 of 612 (0%) at 14-week follow-up in PR21, 12 of 56 (21%) at 4-week follow-up in Start 2 Run and 8 of 532 (1%) at 8-week follow-up in GRONORUN. In the trials using a shoe-related intervention, the numbers of participants who had been fully compliant at the end of follow-up were 207 of 304 (68%) in the 21 week trial, and 322 of 423 (76%), 521 of 577 (90%), 753 of 874 (86%) after 24-week follow-up in the other three trials, respectively. CONCLUSION: The proportion of runners compliant at the end of follow-up ranged from 0% to 21% in the trials using running programme as intervention and from 68% to 90% in the trials using running shoes as intervention. We encourage sports injury researchers to carefully assess and report the compliance with intervention in their articles, use appropriate analytical approaches and take compliance into account when drawing study conclusions. In studies with low compliance, G-estimation may be a useful analytical tool provided certain assumptions are met.

Towards a complex systems approach in sports injury research: simulating running-related injury development with agent-based modelling.

OBJECTIVES: There have been recent calls for the application of the complex systems approach in sports injury research. However, beyond theoretical description and static models of complexity, little progress has been made towards formalising this approach in way that is practical to sports injury scientists and clinicians. Therefore, our objective was to use a computational modelling method and develop a dynamic simulation in sports injury research. METHODS: Agent-based modelling (ABM) was used to model the occurrence of sports injury in a synthetic athlete population. The ABM was developed based on sports injury causal frameworks and was applied in the context of distance running-related injury (RRI). Using the acute:chronic workload ratio (ACWR), we simulated the dynamic relationship between changes in weekly running distance and RRI through the manipulation of various 'athlete management tools'. RESULTS: The findings confirmed that building weekly running distances over time, even within the reported ACWR 'sweet spot', will eventually result in RRI as athletes reach and surpass their individual physical workload limits. Introducing training-related error into the simulation and the modelling of a 'hard ceiling' dynamic resulted in a higher RRI incidence proportion across the population at higher absolute workloads. CONCLUSIONS: The presented simulation offers a practical starting point to further apply more sophisticated computational models that can account for the complex nature of sports injury aetiology. Alongside traditional forms of scientific inquiry, the use of ABM and other simulation-based techniques could be considered as a complementary and alternative methodological approach in sports injury research.

ProjectRun21: Do running experience and running pace influence the risk of running injury-A 14-week prospective cohort study.

OBJECTIVES: The health benefits from participation in half-marathon is challenged by a yearly running-related injury (RRI) incidence proportion exceeding 30%. Research in injury etiology is needed to successfully prevent injuries. The body's load capacity is believed to play an essential role for injury development. Therefore, the purpose of ProjectRun21 was to investigate the association between load capacity defined as running experience and running pace, and RRI when following a specific half-marathon running schedule. DESIGN: A 14-week prospective cohort study. METHODS: A cohort of 784 healthy runners followed a specific half-marathon running schedule. Data on running activity was collected objectively using a Global-Positioning-System watch or smartphone. RRI were collected using e-mail-based weekly questionnaires. Primary exposures were running experience and running pace, dichotomized into a high and a low group for runners running less or more than 15km/week and faster or slower than 6min/km, respectively. Data was analyses through time-to-event models with cumulative risk difference (RD) as measure of association. RESULTS: A total of 136 participants sustained a RRI during follow-up. Although not statistically significant, all estimates indicate a tendency toward fewer injuries amongst runners categorized as having high experience (RD=-11.3% (-27.2% to 4.6%)) or high pace (RD=-17.4% (-39.0% to 4.5%)), and a combination of both high experience and high pace (RD=-8.1% (-22.3% to 6.1%)) compared with their counterpart peers. CONCLUSIONS: Runners covering less than 15km per week, and/or runs slower than 6min/km, may sustain more RRI than their counterpart runners.

Time-to-event analysis for sports injury research part 1: time-varying exposures.

BACKGROUND: 'How much change in training load is too much before injury is sustained, among different athletes?' is a key question in sports medicine and sports science. To address this question the investigator/practitioner must analyse exposure variables that change over time, such as change in training load. Very few studies have included time-varying exposures (eg, training load) and time-varying effect-measure modifiers (eg, previous injury, biomechanics, sleep/stress) when studying sports injury aetiology. AIM: To discuss advanced statistical methods suitable for the complex analysis of time-varying exposures such as changes in training load and injury-related outcomes. CONTENT: Time-varying exposures and time-varying effect-measure modifiers can be used in time-to-event models to investigate sport injury aetiology. We address four key-questions (i) Does time-to-event modelling allow change in training load to be included as a time-varying exposure for sport injury development? (ii) Why is time-to-event analysis superior to other analytical concepts when analysing training-load related data that changes status over time? (iii) How can researchers include change in training load in a time-to-event analysis? and, (iv) Are researchers able to include other time-varying variables into time-to-event analyses? We emphasise that cleaning datasets, setting up the data, performing analyses with time-varying variables and interpreting the results is time-consuming, and requires dedication. It may need you to ask for assistance from methodological peers as the analytical approaches presented this paper require specialist knowledge and well-honed statistical skills. CONCLUSION: To increase knowledge about the association between changes in training load and injury, we encourage sports injury researchers to collaborate with statisticians and/or methodological epidemiologists to carefully consider applying time-to-event models to prospective sports injury data. This will ensure appropriate interpretation of time-to-event data.