E-health intervention for preventing recurrent ankle sprains: a randomised controlled trial in general practice.

BACKGROUND: Ankle sprains are frequent injuries in general practice. However, no effective treatment is available yet. AIM: To examine the effectiveness of an unsupervised e-health-supported neuromuscular training programme in combination with usual care compared with usual care alone in patients with acute lateral ankle sprains in general practice. DESIGN AND SETTING: Randomised controlled trial with 1-year follow-up among patients (14-65 years) who visited the GP with an acute lateral ankle sprain within 3 weeks of injury. METHOD: The intervention group received, in addition to usual care, an unsupervised e-health-supported neuromuscular training programme and the control group received usual care alone. The primary outcome was self-reported re-sprains during 52 weeks of follow-up. Secondary outcomes were ankle function, pain in rest and during activity, subjective recovery, and return to the same type and level of sport. RESULTS: In total, 165 participants (mean age 38.3 years and 69 [41.8%] male) were included. No statistically significant difference in the occurrence of a re-sprain were found between the intervention 20.7% (17/82) and control group 24.1% (20/83) (hazard ratio 1.14, 95% confidence interval = 0.59 to 2.21). Also, no statistically significant differences in secondary outcomes were found between groups. The adherence rate to the programme was low (6.1%, 5/82). CONCLUSION: The rate of re-sprains was relatively high and an unsupervised e-health-supported neuromuscular training programme does not yield meaningful effects and does not encourage adherence in preventing re-sprains in patients in general practice. More research is necessary to indicate the best treatment modality and way of delivery for these patients.

Implementing Individually Tailored Prescription of Physical Activity in Routine Clinical Care: Protocol of the Physicians Implement Exercise = Medicine (PIE=M) Development and Implementation Project.

BACKGROUND: The prescription of physical activity (PA) in clinical care has been advocated worldwide. This "exercise is medicine" (E=M) concept can be used to prevent, manage, and cure various lifestyle-related chronic diseases. Due to several challenges, E=M is not yet routinely implemented in clinical care. OBJECTIVE: This paper describes the rationale and design of the Physicians Implement Exercise = Medicine (PIE=M) study, which aims to facilitate the implementation of E=M in hospital care. METHODS: PIE=M consists of 3 interrelated work packages. First, levels and determinants of PA in different patient and healthy populations will be investigated using existing cohort data. The current implementation status, facilitators, and barriers of E=M will also be investigated using a mixed-methods approach among clinicians of participating departments from 2 diverse university medical centers (both located in a city, but one serving an urban population and one serving a more rural population). Implementation strategies will be connected to these barriers and facilitators using a systematic implementation mapping approach. Second, a generic E=M tool will be developed that will provide tailored PA prescription and referral. Requirements for this tool will be investigated among clinicians and department managers. The tool will be developed using an iterative design process in which all stakeholders reflect on the design of the E=M tool. Third, we will pilot-implement the set of implementation strategies, including the E=M tool, to test its feasibility in routine care of clinicians in these 2 university medical centers. An extensive learning process evaluation will be performed among clinicians, department managers, lifestyle coaches, and patients using a mixed-methods design based on the RE-AIM framework. RESULTS: This project was approved and funded by the Dutch grant provider ZonMW in April 2018. The project started in September 2018 and continues until December 2020 (depending on the course of the COVID-19 crisis). All data from the first work package have been collected and analyzed and are expected to be published in 2021. Results of the second work package are described. The manuscript is expected to be published in 2021. The third work package is currently being conducted in clinical practice in 4 departments of 2 university medical hospitals among clinicians, lifestyle coaches, hospital managers, and patients. Results are expected to be published in 2021. CONCLUSIONS: The PIE=M project addresses the potential of providing patients with PA advice to prevent and manage chronic disease, improve recovery, and enable healthy ageing by developing E=M implementation strategies, including an E=M tool, in routine clinical care. The PIE=M project will result in a blueprint of implementation strategies, including an E=M screening and referral tool, which aims to improve E=M referral by clinicians to improve patients' health, while minimizing the burden on clinicians.

Effects of acute bouts of physical activity on children's attention: a systematic review of the literature.

The aim of this review was to describe the effects of acute bouts of physical activity on attention levels of children. A systematic review was performed of English studies from searches in PubMed, Sportdiscus and PsycINFO from 1990 to (May) 2014 according to the PRISMA statement. Only prospective studies of children aged 4-18 years old were included, detailing acute effects of physical activity bouts with the primary outcome attention. One reviewer extracted data on the study characteristics. Two reviewers conducted the methodological quality assessment independently using a criteria checklist, which was based on the Downs and Black checklist for non-randomised studies. Overall the evidence is thin and inconclusive. The methodological differences in study sample (size and age), study design and measurement of attention make it difficult to compare results. There is weak evidence for the effect of acute bouts of physical activity on attention. More experimental studies with a comparable methodology, especially in the school setting, are needed to strengthen this evidence.

Effects of a web-based intervention on physical activity and metabolism in older adults: randomized controlled trial.

BACKGROUND: Lack of physical activity leads to detrimental changes in body composition and metabolism, functional decline, and increased risk of disease in old age. The potential of Web-assisted interventions for increasing physical activity and improving metabolism in older individuals holds great promise but to our knowledge it has not been studied. OBJECTIVE: The goal of our study was to assess whether a Web-based intervention increases physical activity and improves metabolic health in inactive older adults. METHODS: We conducted a 3-month randomized, waitlist-controlled trial in a volunteer sample of 235 inactive adults aged 60-70 years without diabetes. The intervention group received the Internet program Philips DirectLife, which was directed at increasing physical activity using monitoring and feedback by accelerometer and digital coaching. The primary outcome was relative increase in physical activity measured objectively using ankle- and wrist-worn accelerometers. Secondary outcomes of metabolic health included anthropometric measures and parameters of glucose metabolism. RESULTS: In total, 226 participants (97%) completed the study. At the ankle, activity counts increased by 46% (standard error [SE] 7%) in the intervention group, compared to 12% (SE 3%) in the control group (P(difference)<.001). Measured at the wrist, activity counts increased by 11% (SE 3%) in the intervention group and 5% (SE 2%) in the control group (P(difference)=.11). After processing of the data, this corresponded to a daily increase of 11 minutes in moderate-to-vigorous activity in the intervention group versus 0 minutes in the control group (P(difference)=.001). Weight decreased significantly more in the intervention group compared to controls (-1.5 kg vs -0.8 kg respectively, P=.046), as did waist circumference (-2.3 cm vs -1.3 cm respectively, P=.036) and fat mass (-0.6% vs 0.07% respectively, P=.025). Furthermore, insulin and HbA1c levels were significantly more reduced in the intervention group compared to controls (both P<.05). CONCLUSIONS: This was the first study to show that in inactive older adults, a 3-month Web-based physical activity intervention was effective in increasing objectively measured daily physical activity and improving metabolic health. Such Web-based interventions provide novel opportunities for large scale prevention of metabolic deregulation in our rapidly aging population.

Effectiveness and cost-effectiveness of 'BeweegKuur', a combined lifestyle intervention in the Netherlands: rationale, design and methods of a randomized controlled trial.

BACKGROUND: Improving the lifestyle of overweight and obese adults is of increasing interest in view of its role in several chronic diseases. Interventions aiming at overweight or weight-related chronic diseases suffer from high drop-out rates. It has been suggested that Motivational Interviewing and more frequent and more patient-specific coaching could decrease the drop-out rate. 'BeweegKuur' is a multidisciplinary lifestyle intervention which offers three programmes for overweight persons. The effectiveness and the cost-effectiveness of intensively guided programmes, such as the 'supervised exercise programme' of 'BeweegKuur', for patients with high weight-related health risk, remain to be assessed. Our randomized controlled trial compares the expenses and effects of the 'supervised exercise programme' with those of the less intensively supervised 'start-up exercise programme'. METHODS/DESIGN: The one-year intervention period involves coaching by a lifestyle advisor, a physiotherapist and a dietician, coordinated by general practitioners (GPs). The participating GP practices have been allocated to the interventions, which differ only in terms of the amount of coaching offered by the physiotherapist. Whereas the 'start-up exercise programme' includes several consultations with physiotherapists to identify barriers hampering independent exercising, the 'supervised exercise programme' includes more sessions with a physiotherapist, involving exercise under supervision. The main goal is transfer to local exercise facilities. The main outcome of the study will be the participants' physical activity at the end of the one-year intervention period and after one year of follow-up. Secondary outcomes are dietary habits, health risk, physical fitness and functional capacity. The economic evaluation will consist of a cost-effectiveness analysis and a cost-utility analysis. The primary outcome measures for the economic evaluation will be the physical activity and the number of quality-adjusted life years. Costs will be assessed from a societal perspective with a time horizon of two years. Additionally, a process evaluation will be used to evaluate the performance of the intervention and the participants' evaluation of the intervention. DISCUSSION: This study is expected to provide information regarding the additional costs and effects of the 'supervised exercise programme' in adults with very high weight-related health risk. TRIAL REGISTRATION NUMBER: ISRCTN: ISRCTN46574304.

Ankles back in randomized controlled trial (ABrCt): braces versus neuromuscular exercises for the secondary prevention of ankle sprains. Design of a randomised controlled trial.

BACKGROUND: Ankle sprains are the most common sports and physical activity related injury. There is extensive evidence that there is a twofold increased risk for injury recurrence for at least one year post injury. In up to 50% of all cases recurrences result in disability and lead to chronic pain or instability, requiring prolonged medical care. Therefore ankle sprain recurrence prevention in athletes is essential. This RCT evaluates the effect of the combined use of braces and neuromuscular training (e.g. proprioceptive training/sensorimotor training/balance training) against the individual use of either braces or neuromuscular training alone on ankle sprain recurrences, when applied to individual athletes after usual care. METHODS/DESIGN: This study was designed as three way randomized controlled trial with one year follow-up. Healthy individuals between 12 and 70 years of age, who were actively participating in sports and who had sustained a lateral ankle sprain in the two months prior to inclusion, were eligible for inclusion. After subjects had finished ankle sprain treatment by means of usual care, they were randomised to any of the three study groups. Subjects in group 1 received an eight week neuromuscular training program, subjects in group 2 received a sports brace to be worn during all sports activities for the duration of one year, and group 3 received a combination of the neuromuscular training program and a sports brace to be worn during all sports activities for the duration of eight weeks. Outcomes were assessed at baseline and every month for 12 months therafter. The primary outcome measure was incidence of ankle sprain recurrences. Secondary outcome measures included the direct and indirect costs of recurrent injury, the severity of recurrent injury, and the residual complaints during and after the intervention. DISCUSSION: The ABrCt is the first randomized controlled trial to directly compare the secondary preventive effect of the combined use of braces and neuromuscular training, against the use of either braces or neuromuscular training as separate secondary preventive measures. This study expects to identify the most effective and cost-efficient secondary preventive measure for ankle sprains. The study results could lead to changes in the clinical guidelines on the prevention of ankle sprains, and they will become available in 2012. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR2157.

Effectiveness of a school-based physical activity-related injury prevention program on risk behavior and neuromotor fitness a cluster randomized controlled trial.

BACKGROUND: To investigate the effects of a school-based physical activity-related injury prevention program, called 'iPlay', on risk behavior and neuromotor fitness. METHODS: In this cluster randomized controlled trial 40 primary schools throughout the Netherlands were randomly assigned in an intervention (n = 20) or control group (n = 20). The study includes 2,210 children aged 10-12 years.The iPlay-intervention takes one school year and consists of a teacher manual, informative newsletters and posters, a website, and simple exercises to be carried out during physical education classes.Outcomes measures were self-reported injury preventing behavior, self-reported behavioral determinants (knowledge, attitude, social-influence, self-efficacy, and intention), and neuromotor fitness. RESULTS: The iPlay-program was not able to significantly improve injury-preventing behavior. The program did significantly improve knowledge and attitude, two determinants of behavior. The effect of the intervention-program on behavior appeared to be significantly mediated by knowledge and attitude. Improved scores on attitude, social norm, self-efficacy and intention were significantly related to changes in injury preventing behavior. Furthermore, iPlay resulted in small non-significant improvements in neuromotor fitness in favor of the intervention group. CONCLUSION: This cluster randomized controlled trial showed that the iPlay-program did significantly improved behavioral determinants. However, this effect on knowledge and attitude was not strong enough to improve injury preventing behavior. Furthermore, the results confirm the hypothetical model that injury preventing behavior is determined by intention, attitude, social norm and self-efficacy. TRIAL NUMBER: ISRCTN78846684.