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A Tailored Advice Tool to Prevent Injuries Among Novice Runners: Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Besides the beneficial health effects of being active, running is associated with a risk of sustaining injuries. Runners need to change their behavior to increase the use of effective measures and subsequently reduce the number of running-related injuries. OBJECTIVE:The RunFitCheck intervention was developed according to an evidence- and practice-based approach to stimulate injury-preventive behavior among novice runners. This paper describes the study design in detail. METHODS:A randomized controlled trial with a follow-up period of 5 months will be conducted. The participants will be novice runners. At enrollment, participants will be asked to report injury-preventive measures they usually take during their running activities. After completing the enrollment questionnaire, participants will be randomized to intervention and control groups. The intervention group will have access to the RunFitCheck intervention; the control group will perform their running activities as usual. Participants will be asked to report retrospectively in detail what they have done regarding injury prevention during their running activities at 1, 3, and 5 months after enrollment. Descriptive analyses will be conducted for different baseline variables in the intervention and control group. Relative risks and 95% CIs will be used to analyze behavioral changes according to the intention-to-treat principle. RESULTS:The project was funded in 2016 and enrollment was completed in 2017. Data analysis is currently under way and the results are expected to be submitted for publication in 2019. CONCLUSIONS:To nullify the negative side effects of running, prevention of training errors is desirable. As the use of injury prevention measures is not compulsory in running, a behavioral change is necessary to increase the use of effective injury-preventive measures and to prevent running-related injuries. TRIAL REGISTRATION:Netherlands Trial Register NTR6381; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6381 (Archived by WebCite at http://www.webcitation.org/736Xjm5jv). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR1-10.2196/9708.

SUBMITTER: Kemler E

PROVIDER: S-EPMC6315232 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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A Tailored Advice Tool to Prevent Injuries Among Novice Runners: Protocol for a Randomized Controlled Trial.

Kemler Ellen E Gouttebarge Vincent V

JMIR research protocols 20181219 12

<h4>Background</h4>Besides the beneficial health effects of being active, running is associated with a risk of sustaining injuries. Runners need to change their behavior to increase the use of effective measures and subsequently reduce the number of running-related injuries.<h4>Objective</h4>The RunFitCheck intervention was developed according to an evidence- and practice-based approach to stimulate injury-preventive behavior among novice runners. This paper describes the study design in detail. ...[more]

PMID: 30567686

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Project description:BACKGROUND: Distance running is a popular recreational exercise. It is a beneficial activity for health and well being. However, running may also cause injuries, especially of the lower extremities. In literature there is no agreement what intrinsic and extrinsic factors cause running related injuries (RRIs). In theory, most RRIs are elicited by training errors, this too much, too soon. In a preconditioning program runners can adapt more gradually to the high mechanical loads of running and will be less susceptible to RRIs. In this study the effectiveness of a 4-week preconditioning program on the incidence of RRIs in novice runners prior to a training program will be studied. METHODS/DESIGN: The GRONORUN 2 (Groningen Novice Running) study is a two arm randomized controlled trial studying the effect of a 4-week preconditioning (PRECON) program in a group of novice runners. All participants wanted to train for the recreational Groningen 4-Mile running event. The PRECON group started a 4-week preconditioning program with walking and hopping exercises 4 weeks before the start of the training program. The control (CON) and PRECON group started a frequently used 9-week training program in preparation for the Groningen 4-Mile running event.During the follow up period participants registered their running exposure, other sporting activities and running related injuries in an Internet based running log. The primary outcome measure was the number of RRIs. RRI was defined as a musculoskeletal ailment or complaint of the lower extremities or back causing a restriction on running for at least three training sessions. DISCUSSION: The GRONORUN 2 study will add important information to the existing running science. The concept of preconditioning is easy to implement in existing training programs and will hopefully prevent RRIs especially in novice runners. TRIAL REGISTRATION: The Netherlands National Trial Register NTR1906. The NTR is part of the WHO Primary Registries.

Project description:BackgroundLower extremity overuse injuries are common among runners, especially first-time marathoners. Hip abductor and quadriceps strengthening is often recommended to reduce running-related injuries.HypothesisA 12-week strength training program would decrease the rate of overuse injuries resulting in marathon noncompletion and improve race finishing time.Study designRandomized trial.Level of evidenceLevel 2.MethodsTwelve weeks before the New York City Marathon, first-time marathon runners age 18 years and older were randomized into a strength training group or an observation group. The strength training group was instructed to perform a 10-minute program 3 times weekly using written and video instruction. This program targeted the quadriceps, hip abductor, and core muscle groups. Injuries were self-reported through biweekly surveys, with major injuries being those that resulted in marathon noncompletion and minor injuries being those that impaired training or race performance.ResultsA total of 720 runners were enrolled (mean age, 35.9 ± 9.4 years; 69.4% female), of whom 583 runners started the marathon and 579 completed it. The incidence of major injury was 8.9% and minor injury was 48.5%. Fifty two of 64 major injuries were overuse, of which 20 were bone stress injuries. The incidence of overuse injury resulting in marathon noncompletion was 7.1% in the strength training group and 7.3% in the observation group (risk ratio, 0.97; 95% CI, 0.57-1.63; P = 0.90). The mean finishing time was 5 hours 1 ± 60 minutes in the strength training group and 4 hours 58 ± 55 minutes in the observation group (P = 0.35).ConclusionThere is a high prevalence of injury among first-time marathon runners, but this self-directed strength training program did not decrease overuse injury incidence resulting in marathon noncompletion.Clinical relevancePrevention strategies such as strength training need to be developed and evaluated through clinical trials to reduce the high prevalence of overuse injuries in runners, especially for high-risk populations such as first-time marathon runners.

Project description:BACKGROUND:New technologies, internet accessibility, social media, and increased smartphone ownership provide new opportunities for health researchers to communicate and engage target audiences. An innovative burn prevention intervention was developed using these channels. OBJECTIVE:The aim of this study was to evaluate the efficacy of Cool Runnings, an app-based intervention to increase knowledge of childhood burn risk (specifically hot beverage scalds) and correct burn first aid among mothers of young children. METHODS:This was a 2-group, parallel, single-blinded randomized controlled trial (RCT). Participants were women aged 18 years and above, living in Queensland, Australia, with at least 1 child aged 5-12 months at time of enrollment. The primary outcome measures were change in knowledge about risk of burns and correct burn first aid assessed via 2 methods: (1) overall score and (2) categorized as adequate (score=4) versus inadequate (score<4). Efficacy of gamification techniques was also assessed. RESULTS:In total, 498 participants were recruited via social media and enrolled. At the 6-month follow-up, 244 participants completed the posttest questionnaire. Attrition rates in both groups were similar. Participants who remained in the study did not differ from those lost to follow-up on any characteristics except education level. Although similar at baseline, intervention group participants achieved significantly greater improvement in overall knowledge posttest than control group participants on both primary outcome measures (overall knowledge intervention: mean [SD] of overall knowledge 2.68 [SD 1.00] for intervention vs 2.13 [SD 1.03] for control; 20.7% [25/121] adequate in intervention vs 7.3% [2/123] in control). Consequently, the number needed to treat was 7.46. Logistic regression showed participants exposed to the highest level of disadvantage had 7.3 times higher odds of improved overall knowledge scores than participants in other levels of disadvantage. There were also significant correlations between gamification techniques and knowledge change (P<.001). In addition, odds of knowledge improvement between baseline and 6-month follow-up was higher in participants with low-moderate app activity compared with no app activity (odds ratio [OR] 8.59, 95% CI 2.9-25.02) and much higher in participants with high app activity (OR 18.26, 95% CI 7.1-46.8). CONCLUSIONS:Despite substantial loss to follow-up, this RCT demonstrates the Cool Runnings app was an effective intervention for improving knowledge about risks of hot beverage scalds and burn first aid in mothers of young children. The benefits of combining gamification elements in the intervention were also highlighted. Given the low cost and large reach of smartphone apps to deliver content to and engage with targeted populations, the results from this RCT provide important information on how smartphone apps can be used for widespread injury prevention campaigns and public health campaigns generally. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12616000019404; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369745&showOriginal=true&isReview=true (Archived by WebCite at http://www.webcitation.org/72b1E8gTW).

Project description:BackgroundOsteoarthritis is a common and disabling condition that places heavy burden to individuals and healthcare systems. Patient education is a facilitator in the treatment decision making process, aiming to develop a treatment plan for the disease management. Electronic health (eHealth) is an alternative forum for the delivery of patient education and given the prevailing of eHealth in healthcare, introducing patient education programs using the technology has the potential to improve patient engagement, self-management and outcomes in patients with osteoarthritis. The study will evaluate the efficacy of eHealth patient education tool on patients' perception of knee osteoarthritis and treatment options, satisfaction and compliance to treatments.MethodsThis study is a prospective randomized controlled trial with a 1:1 allocation in two groups. We will recruit 216 patients diagnosed with knee osteoarthritis from the outpatient physiatry/physiotherapy clinic at West China Hospital, Sichuan University in Southwest China. Both groups will receive usual care and additionally, the intervention group will use eHealth patient education tool during the process. Measurements will be taken at baseline, post-intervention, 1 month, 3- and 6-months follow-up. Primary outcome will be patients' knowledge about disease and treatment options, measured by the validated osteoarthritis patient knowledge questionnaire. Secondary outcomes include patients' satisfaction with the consultation, the eHealth patient education tool, and their trust of the physiotherapist.DiscussionThe eHealth patient education tool is designed to provide participants with an innovative model of care delivery and this trial will assess the efficacy of the tool and whether this new model of patient education will have the potential to increase patient knowledge and empower self-management. Results collected from this study will further inform future research employing eHealth tool as interventions for the management of a range of other chronic conditions and help participants in communities or rural areas having the equal access to health care services.Trial registrationThis study was prospectively registered on the Chinese Clinical Trials Registry ( ChiCTR2100051083 ) registered 12.09.2021.

Project description:Elevated low-density lipoprotein (LDL) cholesterol is a leading risk factor for cardiovascular disease. Despite the availability of proven interventions to lower LDL cholesterol, their use remains subobtimal. Many websites provide interactive, tailored advice on cardiovascular risk in an attempt to help bridge this evidence-practice gap, yet there is little evidence that provision of such a tool is effective in changing practice.The objective was to define the effects on use of cholesterol-lowering interventions of a consumer-targeted tailored advice website.This was a prospective, double-blind, randomized controlled trial open to any adult Australian with access to the Internet. A total of 2099 participants were randomized. Of these, 45% were male, the mean age of all participants was 56, and 1385 (66%) self-reported hypercholesterolemia. Follow-up information was obtained for 1945 (93%). Participants completed a brief online questionnaire. Individuals assigned to intervention received immediate, fully automated, personally tailored advice (based on current guidelines) regarding the need for commencement of statin therapy, increased statin therapy in those already on treatment, and nondrug intervention strategies. Control group participants were directed to static Web pages providing general information about cholesterol management.The primary outcome was the proportion of participants that commenced or increased use of prescribed cholesterol-lowering therapy. Of the total 2099 randomized participants, 304 (14%) met eligibility criteria for cholesterol-lowering therapy but were not prescribed treatment, and 254 (12%) were prescribed treatment but were not achieving the recommended target level. Treatment was commenced or increased in 64 (6.0%) of the 1062 intervention group participants and 79 (7.6%) of the 1037 control group participants (% difference = -1.6%, 95% confidence interval [CI] -3.75 to 0.57, P = .15). No differences were found between the randomized groups for the secondary outcomes of "discussed treatment with a health professional" (% difference = -3.8%, 95% confidence interval [CI] -8.16 to 0.19, P = .08), "had their cholesterol checked" (% difference = -1.5%, 95% CI -5.79 to 2.71, P = .48), "had their blood pressure checked" (% difference = 1.4%, 95% CI -2.55 to 5.34, P = .49) or made a lifestyle change (P values between .49 and .96).Despite providing specific carefully tailored advice, this website had no detectable effect on cholesterol management strategies. This finding raises considerable uncertainty about the value of Internet-based tools providing tailored advice directly to consumers.NCT00220974; http://clinicaltrials.gov/ct2/show/NCT00220974 (Archived by WebCite at http://www.webcitation.org/5sdq63rrY).

Project description:Background In contrast to severe gestational hypertension, it is questioned whether antihypertensive medication for mild to moderate gestational hypertension prevents adverse maternal and offspring outcomes. Hypertensive drugs halve the risk of severe hypertension, but do not seem to prevent progression to preeclampsia or reduce the risk of complications in offspring. In fact, beta-blockers, a first line therapy option, are suspected to impair foetal growth. Disappointing effects of antihypertensive medication can be anticipated when the pharmacological mode of action does not match the underlying haemodynamic imbalance. Hypertension may result from 1) high cardiac output, low vascular resistance state, in which beta blockade is expected to be most effective, or 2) low cardiac output, high vascular resistance state where dihydropyridine calcium channel blockers or central-acting alpha agonists might be the best corrective medication. In the latter, beta-blockade might be maternally ineffective and even contribute to impaired foetal growth by keeping cardiac output low. We propose a randomized controlled trial to determine whether correcting the haemodynamic imbalance in women with mild to moderate hypertension reduces the development of severe hypertension and/or preeclampsia more than non-pharmacological treatment does, without alleged negative effects on foetal growth. Methods Women diagnosed with mild to moderate hypertension without proteinuria or signs of other organ damage before 37?weeks of pregnancy are invited to participate in this randomized controlled trial. Women randomized to the intervention group will be prescribed tailored antihypertensive medication, using a simple diagnostic and treatment algorithm based on the mean arterial pressure/heart rate ratio, which serves as an easy-to-determine proxy for maternal circulatory state. Women randomized to the control group will receive non-pharmacological standard care according to national and international guidelines. In total, 208 women will be randomized in a 1:1 ratio. The primary outcome is progression to severe hypertension and preeclampsia and the secondary outcomes are adverse maternal and neonatal outcomes. Discussion This trial will provide evidence of whether tailoring treatment of mild to moderate gestational hypertension to the individual haemodynamic profile prevents maternal disease progression. Trial registration NCT02531490, registered on 24 August 2015.

Project description:BackgroundLung cancer screening is a US Preventive Services Task Force Grade B recommendation that has been shown to decrease lung cancer-related mortality by approximately 20%. However, making the decision to screen, or not, for lung cancer is a complex decision because there are potential risks (eg, false positive results, overdiagnosis). Shared decision making was incorporated into the lung cancer screening guideline and, for the first time, is a requirement for reimbursement of a cancer screening test from Medicare. Awareness of lung cancer screening remains low in both the general and screening-eligible populations. When a screening-eligible person visits their clinician never having heard about lung cancer screening, engaging in shared decision making to arrive at an informed decision can be a challenge. Methods to effectively prepare patients for these clinical encounters and support both patients and clinicians to engage in these important discussions are needed.ObjectiveThe aim of the study was to estimate the effects of a computer-tailored decision support tool that meets the certification criteria of the International Patient Decision Aid Standards that will prepare individuals and support shared decision making in lung cancer screening decisions.MethodsA pilot randomized controlled trial with a community-based sample of 60 screening-eligible participants who have never been screened for lung cancer was conducted. Approximately half of the participants (n=31) were randomized to view LungTalk-a web-based tailored computer program-while the other half (n=29) viewed generic information about lung cancer screening from the American Cancer Society. The outcomes that were compared included lung cancer and screening knowledge, lung cancer screening health beliefs (perceived risk, perceived benefits, perceived barriers, and self-efficacy), and perception of being prepared to engage in a discussion about lung cancer screening with their clinician.ResultsKnowledge scores increased significantly for both groups with greater improvement noted in the group receiving LungTalk (2.33 vs 1.14 mean change). Perceived self-efficacy and perceived benefits improved in the theoretically expected directions.ConclusionsLungTalk goes beyond other decision tools by addressing lung health broadly, in the context of performing a low-dose computed tomography of the chest that has the potential to uncover other conditions of concern beyond lung cancer, to more comprehensively educate the individual, and extends the work of nontailored decision aids in the field by introducing tailoring algorithms and message framing based upon smoking status in order to determine what components of the intervention drive behavior change when an individual is informed and makes the decision whether to be screened or not to be screened for lung cancer.International registered report identifier (irrid)RR2-10.2196/resprot.8694.

Dataset Information

A Tailored Advice Tool to Prevent Injuries Among Novice Runners: Protocol for a Randomized Controlled Trial.

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A Tailored Advice Tool to Prevent Injuries Among Novice Runners: Protocol for a Randomized Controlled Trial.

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