Study protocol of a randomized, double-blind, placebo-controlled, multi-center trial to treat antipsychotic-induced weight gain: the Metformin-Lifestyle in antipsychotic users (MELIA) trial.

BACKGROUND: Antipsychotic-induced Weight Gain (AiWG) is a debilitating and common adverse effect of antipsychotics. AiWG negatively impacts life expectancy, quality of life, treatment adherence, likelihood of developing type-2 diabetes and readmission. Treatment of AiWG is currently challenging, and there is no consensus on the optimal management strategy. In this study, we aim to evaluate the use of metformin for the treatment of AiWG by comparing metformin with placebo in those receiving treatment as usual, which includes a lifestyle intervention. METHODS: In this randomized, double-blind, multicenter, placebo-controlled, pragmatic trial with a follow-up of 52 weeks, we aim to include 256 overweight participants (Body Mass Index (BMI) > 25 kg/m2) of at least 16 years of age. Patients are eligible if they have been diagnosed with schizophrenia spectrum disorder and if they have been using an antipsychotic for at least three months. Participants will be randomized with a 1:1 allocation to placebo or metformin, and will be treated for a total of 26 weeks. Metformin will be started at 500 mg b.i.d. and escalated to 1000 mg b.i.d. 2 weeks thereafter (up to a maximum of 2000 mg daily). In addition, all participants will undergo a lifestyle intervention as part of the usual treatment consisting of a combination of an exercise program and dietary consultations. The primary outcome measure is difference in body weight as a continuous trait between the two arms from treatment inception until 26 weeks of treatment, compared to baseline. Secondary outcome measures include: 1) Any element of metabolic syndrome (MetS); 2) Response, defined as ≥5% body weight loss at 26 weeks relative to treatment inception; 3) Quality of life; 4) General mental and physical health; and 5) Cost-effectiveness. Finally, we aim to assess whether genetic liability to BMI and MetS may help estimate the amount of weight reduction following initiation of metformin treatment. DISCUSSION: The pragmatic design of the current trial allows for a comparison of the efficacy and safety of metformin in combination with a lifestyle intervention in the treatment of AiWG, facilitating the development of guidelines on the interventions for this major health problem. TRIAL REGISTRATION: This trial was registered in the Netherlands Trial Register (NTR) at  https://www.trialregister.nl/trial/8440 as NTR NL8840 on March 8, 2020.

Effective But Not Adhered to: How Can We Improve Adherence to Evidence-Based Hamstring Injury Prevention in Amateur Football?

OBJECTIVES: To investigate adherence to a Nordic hamstring exercise (NHE) program in a real-world context of male amateur football, and the perceptions of end users (players) and intervention deliverers (coaches and medical staff) about adherence to this proven effective program. DESIGN: Retrospective cohort study. SETTING: Dutch amateur football. PARTICIPANTS: Two hundred sixty-four players, 23 coaches, and 29 medical staff from Dutch amateur football teams that participated in a national randomized controlled trial 2 years earlier. INDEPENDENT VARIABLES: Nordic hamstring exercise program. MAIN OUTCOME MEASURES: Nordic hamstring exercise program adherence during 2014 and 2015. Intervention or control group allocation during the trial, transfers, and personal perception about adherence to the program were also examined. RESULTS: Of all players, 69% reported never, 16% sometimes, 6% frequently, 5% often, and 4% always performing exercises of the NHE program. Adherence to the NHE program was higher among players who had been in the NHE arm of the previous trial and among players who had not been transferred to another club compared with players who had been transferred. Key factors in stimulating players to adhere to the NHE program were knowledge of the NHE and personal motivation. Coaches and medical staff members also mentioned personal motivation and consensus with team staff as key factors to encourage NHE adherence. CONCLUSIONS: Among high-level male amateur football players, adherence to an evidence-based hamstring injury-prevention program was very low. It is essential to recognize factors that stimulate or limit adherence to injury-prevention programs for effective programs to actually lead to a reduction in hamstring injuries in a real-world context.

Physical activity, sports participation and exercise-related constraints in adult women with primary hypothyroidism treated with thyroid hormone replacement therapy.

Awareness of physical activity (PA) constraints in patients with primary hypothyroidism on thyroid hormone replacement therapy (THR) is important. Hence, this cross-sectional matched case-control study aimed to determine PA and sports participation (SP) in patients with hypothyroidism on THR in comparison to control subjects. Accordingly, survey questions were selected from the National Survey on Injuries and Physical Activity in the Netherlands (IPAN), supplemented with questions related to self-reported clinical characteristics and exercise-related constraints (ERC) of patients. In total, 1,724 female patients (mean age 53.0 years ±11.6) and 1,802 controls (mean age 52.6 ± 13.2) were included. Compared to controls, patients were less likely to comply with the moderate-intensity PA guideline (OR 0.70; 95% CI: 0.611-0.803), although patients were more actively participating in sports (OR 1.40; 95% CI: 1.156-1.706). Two-thirds of patients reported that hypothyroidism was limiting their PA performance. These limitations were more pronounced in patients with autoimmune thyroiditis (AIT) than in patients with hypothyroidism from other aetiology (OR 1.93; 95% CI: 1.518-2.457), representing disease-specific exercise intolerance. In order to establish effective intervention programmes to encourage regular PA in hypothyroid patients on THR with exercise intolerance, further research is warranted to better understand PA barriers.

Sports Participation, Physical Activity, and Health-Related Fitness in Youth With Chronic Diseases or Physical Disabilities: The Health in Adapted Youth Sports Study.

ABSTRACT: Lankhorst, K, Takken, T, Zwinkels, M, van Gaalen, L, Velde, St, Backx, F, Verschuren, O, Wittink, H, and de Groot, J. Sports participation, physical activity, and health-related fitness in youth with chronic diseases or physical disabilities: the health in adapted youth sports study. J Strength Cond Res 35(8): 2327-2337, 2021-Youth with chronic diseases or physical disabilities (CDPD) often show reduced fitness and physical activity (PA) levels and participate less in organized sports compared with healthy peers. The purpose of this study was to examine the associations between participation in sports and health-related fitness and PA in youth with CDPD. A total of 163 subjects (mean age 14 years; range 8-19 years) with CDPD were included in this cross-sectional study, with 81 participating in organized sports and 82 not. Subjects were recruited between October 2014 and November 2016. Aerobic and anaerobic fitness, agility, and muscle strength were assessed in the laboratory, whereas PA was monitored in daily life using accelerometry during 1 week. Linear regression analyses were used to assess the associations of sports participation (independent variable) with health-related fitness and PA (dependent variables). Results show that youth with CDPD participating in organized sports 2 times a week performed better on all outcome measures. They reached a higher peak oxygen uptake (difference of 4.9 ml O2·kg-1·min-1, P = 0.001) compared with their peers not participating in sports. Also, anaerobic fitness, agility, muscle strength, and PA were all positively associated with sports participation. Moreover, the association between sports participation and aerobic fitness was mediated by PA for 31% (P = 0.045). In conclusion, participation in sports is associated with both higher levels of PA and health-related fitness in youth with CDPD. Promotion and stimulation of participation in sports seems a good way to promote health-related fitness as well as a healthy active lifestyle in youth with CDPD.

The preventive effect of a soccer-specific ankle brace on acute lateral ankle sprains in girls amateur soccer players: study protocol of a cluster-randomised controlled trial.

BACKGROUND: Acute lateral ankle sprains are the single most often diagnosed injury in female soccer players and often result in an inability to play. This highlights the need for effective prevention strategies. Proprioceptive training and/or the use of an external support to decrease inversion of the ankle joint can prevent or reduce the number of acute lateral ankle sprains. The effectiveness of a soccer-specific ankle brace in reducing first-time and recurrent acute lateral ankle sprains has never been investigated in girl soccer players. If effective, ankle braces could be introduced into soccer. STUDY DESIGN: Cluster-randomised controlled trial. METHODS: Girl amateur soccer players (aged 14-18 years) will be allocated to an intervention or control group. The intervention group will be instructed to wear soccer-specific ankle braces on both ankles during soccer training and matches; the control group will continue playing soccer as usual. Primary outcomes are the incidence and severity of acute lateral ankle sprains. Secondary outcomes are the prognostic value of generalised joint hypermobility and functional stability on the risk of acute lateral ankle sprains and compliance with the intervention. DISCUSSION: The findings from this study may provide evidence to support the use of a soccer-specific ankle brace to prevent lateral ankle sprains during soccer. We hypothesise that this brace will reduce the incidence of ankle sprains among young amateur girl soccer players by 50%. The prevention of such injuries will be beneficial to players, clubs and society. TRIAL REGISTRATION NUMBER: The Netherlands Trial Register (NTR): NTR6045; Pre-results.

Does a bounding exercise program prevent hamstring injuries in adult male soccer players? - A cluster-RCT.

BACKGROUND: Although the Nordic Hamstring Exercise (NHE) prevents hamstring injury in soccer players effectively, the annual incidence of these injuries still increases. This may be because of poor long-term compliance with the program. Furthermore, the timing and amplitude of gluteal and core muscle activation seem to play an important role in hamstring injury prevention, the NHE program was not designed to improve activation of these muscles. Therefore, we propose plyometric training as an alternative to reduce hamstring injuries in soccer players. PURPOSE: To determine the preventive effect of the Bounding Exercise Program (BEP) on hamstring injury incidence and severity in adult male amateur soccer players. STUDY DESIGN: A cluster-Randomized Controlled Trial. METHODS: Thirty-two soccer teams competing in the first-class amateur league were cluster-randomized into the intervention or control group. Both groups were instructed to perform their regular training program, and the intervention group additionally performed BEP. Information about player characteristics was gathered at baseline and exposure, hamstring injuries and BEP compliance were weekly registered during one season (2016-2017). RESULTS: The data of 400 players were analyzed. In total, 57 players sustained 65 hamstring injuries. The injury incidence was 1.12/1000 hours in the intervention group and 1.39/1000 hours in the control group. There were no statistically significant differences in hamstring injury incidence (OR = 0.89, 95% CI 0.46-1.75) or severity between the groups (P > 0.48). CONCLUSION: In this large cluster-randomized controlled trial, no evidence was found for plyometric training in its current form to reduce hamstring injuries in amateur soccer players.

Physical activity in wheelchair-using youth with spina bifida: an observational study.

BACKGROUND: Even though typically developing youth are already at risk for physical inactivity, youth with spina bifida may be even at higher risk as a consequence of their reduced mobility. No objective data is available for youth with spina bifida who use a manual wheelchair, so the seriousness of the problem is unknown. The purpose of this observational study was to quantify physical activity in wheelchair-using youth with spina bifida and evaluate the intensity of activities. METHODS: Fifty-three children and adolescents (5-19 years) with spina bifida who use a manual wheelchair for daily life, long distances or sports were included. To assess time spent in several types of activities VitaMove data of 34 participants were used and were presented as time spent sedentary and time spent physically active. This was compared to reference data of typically developing youth. To assess time spent in several intensities Actiheart data of 36 participants were used. The intensities were categorized according to the American College of Sports Medicine, ranging from very light intensity to near to maximal intensity. Data of 25 participants were used to combine type of activity and intensity. RESULTS: Children and adolescents with spina bifida who use a manual wheelchair were more sedentary (94.3% versus 78.0% per 24 h, p < 0.000) and less physically active (5.0% versus 12.2% per 24 h, p < 0.000) compared to typically developing peers. Physical activity during weekend days was worse compared to school days; 19% met the Guidelines of Physical Activity during school days and 8% during weekend days. The intensities per activity varied extensively between participants. CONCLUSIONS: Children and adolescents with spina bifida who use a manual wheelchair are less physically active and more sedentary than typically developing youth. The physical activity levels on school days seem to be more favorable than the physical activity levels on a weekend day. The low levels of physical activity need our attention in pediatric rehabilitation practice. The different intensities during activities indicate the importance of individually tailored assessments and interventions.

Effects of High-Intensity Interval Training on Fitness and Health in Youth With Physical Disabilities.

PURPOSE: To investigate the effects of high-intensity interval training (HIT) on physical fitness and cardiometabolic health in youth with physical disabilities. METHODS: For this quasi-experimental study 70 participants were recruited from schools for special education and divided into runners and users of wheelchairs. HIT was performed for 8 weeks, twice a week, containing 30 seconds all-out exercises. RESULTS: Exercise adherence was 84.5%. Following HIT, there were improvements in anaerobic performance, agility, aerobic performance, and systolic and diastolic blood pressure. There were no changes in peak oxygen uptake ((Equation is included in full-text article.)O2peak), arterial stiffness, body composition, lipid profile, and fasting glucose. CONCLUSIONS: Both anaerobic and aerobic performance improved after HIT, with no changes in (Equation is included in full-text article.)O2peak. There were no effects on cardiometabolic health, except for a decrease in blood pressure.

Validity of injury self-reports by novice runners: comparison with reports by sports medicine physicians.

This study examined the criterion validity of self-reported running-related injuries (RRI) by novice runners. Fifty-eight participants (41 females; age 46 ± 11 yrs) of the "Start-to-Run" program provided self-reports on their RRIs using an online questionnaire. Subsequently, they attended injury consultations with sports medicine physicians who provided physician-reports (blinded for the self-reports) as a reference standard. Self-reports and physician-reports included information on injury location (i.e., hip/groin, upper leg, knee, lower leg, and ankle/foot) and injury type (i.e., muscle-tendon unit, joint, ligament, or bone). Sensitivity, specificity, and positive predictive values were 100% for all five injury locations. For injury type, sensitivity was low (66% for muscle-tendon unit, 50% for ligament, and 40% for bone) and lowest for joint injuries (17%). In conclusion, the validity of self-reported RRIs by novice runners is good for injury locations but not for injury types. In particular for joint injuries, the validity of novice runners' self-reports is low. Abbreviations: RRI: Running Related Injury; SMC: Sports Medicine Centre; MTU: Muscle Tendon Unit; PPV: Positive Predictive Value.

The 2017 Dutch Physical Activity Guidelines.

BACKGROUND: The objective of this study was to derive evidence-based physical activity guidelines for the general Dutch population. METHODS: Two systematic reviews were conducted of English language meta-analyses in PubMed summarizing separately randomized controlled trials and prospective cohort studies on the relation between physical activity and sedentary behaviour on the one hand and the risk of all-cause mortality and incidence of 15 major chronic diseases and conditions on the other hand. Other outcome measures were risk factors for cardiovascular disease and type 2 diabetes, physical functioning, and fitness. On the basis of these reviews, an expert committee derived physical activity guidelines. In deriving the guidelines, the committee first selected only experimental and observational prospective findings with a strong level of evidence and then integrated both lines of evidence. RESULTS: The evidence found for beneficial effects on a large number of the outcome measures was sufficiently strong to draw up guidelines to increase physical activity and reduce sedentary behaviour, respectively. At the same time, the current evidence did not provide a sufficient basis for quantifying how much physical activity is minimally needed to achieve beneficial health effects, or at what amount sedentary behaviour becomes detrimental. A general tenet was that at every level of current activity, further increases in physical activity provide additional health benefits, with relatively larger effects among those who are currently not active or active only at light intensity. Three specific guidelines on (1) moderate- and vigorous-intensity physical activity, (2) bone- and muscle-strengthening activities, and (3) sedentary behaviour were formulated separately for adults and children. CONCLUSIONS: There is an unabated need for evidence-based physical activity guidelines that can guide public health policies. Research in which physical activity is measured both objectively (quantity) and subjectively (type and quality) is needed to provide better estimates of the type and actual amount of physical activity required for health.

Validity and Reliability of Skill-Related Fitness Tests for Wheelchair-Using Youth With Spina Bifida.

OBJECTIVES: To determine content validity of the Muscle Power Sprint Test (MPST), and construct validity and reliability of the MPST, 10×5 Meter Sprint Test (10×5MST), slalom test, and One Stroke Push Test (1SPT) in wheelchair-using youth with spina bifida (SB). DESIGN: Clinimetric study. SETTING: Rehabilitation centers, SB outpatient services, and private practices. PARTICIPANTS: A convenience sample of children and adolescents (N=53; 32 boys, 21 girls; age range, 5-19y) with SB who use a manual wheelchair. Participants were recruited through rehabilitation centers, SB outpatient services, pediatric physical therapists, and the BOSK (Association of Physically Disabled Persons and their Parents). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Construct validity of the MPST was determined by comparing results with the arm-cranking Wingate Anaerobic Test (WAnT) using paired t tests and Pearson correlation coefficients, while content validity was assessed using time-based criteria for anaerobic testing. Construct validity of the 10×5MST, slalom test, and 1SPT was analyzed by hypothesis testing using Pearson correlation coefficients and multiple regression. For reliability, intraclass correlation coefficients (ICCs) and smallest detectable changes (SDCs) were calculated. RESULTS: For the MPST, the mean ± SD exercise time of 4 sprints was 28.1±6.6 seconds. Correlations between the MPST and arm-cranking WAnT were high (r>.72, P<.01). Excellent correlations were found between the 10×5MST and slalom test (r=.93, P<.01), while correlations between the 10×5MST or slalom test and MPST and 1SPT were moderate (r=-.56 to -.70; r=.56, P<.01). The variation of the 1SPT was explained for 38% by wheelchair mass (ß=-.489) and total upper muscle strength (ß=.420). All ICCs were excellent (ICCs>.95), but the SDCs varied widely. CONCLUSIONS: The MPST is a valid and reliable test in wheelchair-using youth with SB for measuring anaerobic performance. The 10×5MST and slalom test are valid and reliable for measuring agility. For the 1SPT, both validity and reliability are questionable.

Alfredson versus Silbernagel exercise therapy in chronic midportion Achilles tendinopathy: study protocol for a randomized controlled trial.

BACKGROUND: Midportion Achilles tendinopathy (AT) is a common overuse injury, usually requiring several months of rehabilitation. Exercise therapy of the ankle plantar flexors (i.e. tendon loading) is considered crucial during conservative rehabilitation. Alfredson's isolated eccentric and Silbernagel's combined concentric-eccentric exercise programs have both shown beneficial results, but it is unknown whether any of these programs is superior for use in clinical practice. Therefore, the primary objective of this study is to compare the effectiveness of both programs on clinical symptoms. Secondary objectives are to compare the effectiveness of both programs on quality of life and functional outcome measures, to investigate the prognostic value of baseline characteristics, to investigate differences in cost-effectiveness. METHODS/DESIGN: Eighty-six recreational athletes (21-60 years of age) with unilateral chronic midportion AT (i.e. ≥ 3 months) will be included in this multicenter assessor blinded randomized controlled trial. They will be randomly allocated to either a group performing the Alfredson isolated eccentric training program (n = 43), or a group performing the Silbernagel combined concentric-eccentric program (n = 43). In the Alfredson group, participants will perform eccentric heel-drops on their injured side, twice daily for 12 weeks, whereas in the Silbernagel group, participants perform various concentric-eccentric heel-raise exercises, once daily for 12 weeks. Primary outcome measure will be the Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire. Secondary outcomes will be a visual analogue scale (VAS) for pain during daily activities and sports, duration of morning stiffness, global perceived effect, the 12-item Short Form Health Survey and the Euroqol instrument, and functional performance measured with the heel-raise test and the countermovement jump. Additionally, alongside the RCT, a cost-effectiveness analysis will be performed. Assessments will be performed at baseline and after 12, 26, and 52 weeks. DISCUSSION: This study is the first to directly compare the Alfredson and the Silbernagel exercise program in a randomized trial. The results can further enlarge the evidence base for choosing the most appropriate exercise program for patients with midportion AT. TRIAL REGISTRATION: Dutch Trial register: NTR5638 . Date of registration: 7 January 2016.

Hamstring-and-Lower-Back Flexibility in Male Amateur Soccer Players.

OBJECTIVE: This study investigated the hamstring-and-lower-back flexibility (HLBF) of male adult amateur soccer players, using the sit-and-reach test (SRT), with a view to obtaining population-based reference values and to determining whether SRT scores are associated with player characteristics. DESIGN: Cross-sectional cohort study. SETTING: Teams from high-level Dutch amateur soccer competitions were recruited for participation. PARTICIPANTS: Dutch male high-level amateur field soccer players (n = 449) of age 18 to 40 years. Players with a hamstring injury at the moment of SRT-measurement or any other injury that prevented them from following the SRT protocol were excluded. MAIN OUTCOME MEASURES: Sit-and-reach test scores were measured and then population-based reference values were calculated as follows: >2SD below mean (defining "very low" HLBF), 1SD-2SD below mean ("low" HLBF), 1SD below mean to 1SD above mean ("normal" HLBF), 1SD-2SD above mean ("high" HLBF), and >2SD above mean ("very high" HLBF). Whether SRT scores were correlated with player characteristics was determined using a Pearson correlation coefficient or Spearman rho. RESULTS: Sit-and-reach test scores ranged from 0 to 43.5 cm (mean 22.0 cm, SD 9.2). The cutoff points for population-based reference values were <3.5 cm for "very low", 3.5 to 13.0 cm for "low", 13.0 to 31.0 cm for "normal", 31.0 to 40.5 cm for "high", and >40.5 cm for "very high". Sit-and-reach test scores were significantly associated with players' height (ρ = -0.132, P = 0.005), body mass index (r = 0.114, P = 0.016), and history of anterior cruciate ligament surgery (P < 0.001). CONCLUSIONS: This study is the first to describe the HLBF of amateur soccer players. The SRT reference values with cutoff points may facilitate evidence-based decision making regarding HLBF, and the SRT might be a useful tool to assess injury risk, performance, or for diagnostic purposes.

Effectiveness of Shockwave Treatment Combined With Eccentric Training for Patellar Tendinopathy: A Double-Blinded Randomized Study.

OBJECTIVE: To evaluate the effectiveness of a combined treatment of focused shockwave therapy (ESWT) and eccentric training compared with sham-shockwave therapy (placebo) and eccentric training in participants with patellar tendinopathy (PT) after 24 weeks. DESIGN: Randomized controlled trial. SETTING: Sports medicine departments of a university hospital and a general hospital in the Netherlands. PARTICIPANTS: Fifty-two physically active male and female participants with a clinical diagnosis of PT (mean age: 28.6 years; range, 18-45) were randomly allocated to the ESWT (n = 22) or sham shockwave (n = 30). INTERVENTIONS: Extracorporeal shockwave therapy and sham shockwave were applied in 3 sessions at 1-week intervals with a piezoelectric device. All participants were instructed to perform eccentric exercises (3 sets of 15 repetitions twice a day) for 3 months on a decline board at home. MAIN OUTCOME MEASURES: The Victorian Institute of Sport Assessment-Patella (VISA-P) scores (primary), pain scores during functional knee loading tests, and Likert score (secondary) were registered at baseline and at 6, 12, and 24 weeks after the start with the ESWT or sham-shockwave treatment. RESULTS: No significant differences for the primary and secondary outcome measures were found between the groups. In the ESWT/eccentric group, the VISA-P increased from 54.5 ± 15.4 to 70.9 ± 17.8, whereas the VISA-P in the sham-shockwave/eccentric group increased from 58.9 ± 14.6 to 78.2 ± 15.8 (between-group change in VISA-P at 24 weeks -4.8; 95% confidence interval, -12.7 to 3.0, P = 0.150). CONCLUSIONS: This study showed no additional effect of 3 sessions ESWT in participants with PT treated with eccentric exercises. The results should be interpreted with caution because of small sample size and considerable loss to follow-up, particularly in the ESWT group.

Decreased physical activity, reduced QoL and presence of debilitating fatigue in patients with Addison's disease.

BACKGROUND: Health-related quality of life in patients with Addison's disease has been assessed in various European countries, indicating a reduced quality of life. However, no studies have addressed the impact of Addison's disease on physical activity. OBJECTIVE: The aim of this study was to investigate the quality of life in Dutch patients with Addison's disease particularly regarding the presence of fatigue and the ability to be physically active. METHODS: In this cross-sectional study, a postal survey was performed among Dutch patients with Addison's disease on stable glucocorticoid replacement therapy with hydrocortisone or cortisone acetate. For quality of life and physical activity assessment, patients completed general and health-related quality of life and physical activity questionnaires, and scores were compared to Dutch controls. RESULTS: A total of 328 patients with Addison's disease were studied. In patients with Addison's disease, only 45·7% met the standard of physical activity (Combinorm) compared to 67·8% of Dutch controls (P < 0·01). Forty-eight per cent of patients showed abnormal fatigue, while 61% had severe fatigue. The CIS fatigue scores were significantly higher compared to controls (P < 0·01). We found reduced general subjective health-related QoL scores in both male and female patients, especially in younger patients <65 years of age. CONCLUSION: Physical activity is decreased in patients with Addison's disease, combined with a reduced subjective health-related QoL and increased fatigue.

Long-term prognosis of acute lateral ankle ligamentous sprains: high incidence of recurrences and residual symptoms.

BACKGROUND: Acute lateral ankle ligamentous sprains (ALALS) are common injuries. This injury does not always have a favourable long-term outcome. Studies reporting the prognosis of ALALS after functional treatment are scarce. OBJECTIVE: To determine the prognosis of functionally treated ALALS, in terms of recurrent ALALS and residual symptoms. STUDY DESIGN: Retrospective cohort study. SETTING: Patients were recruited from 20 family practices, nine physical therapy practices, the emergency departments of a regional hospital and a university hospital. PATIENTS: Adult patients with an ALALS caused by an inversion trauma were invited to participate in this study 2.5-5 years after their initial injury. INDEPENDENT VARIABLES: Functional treatment of the initial ALALS. MAIN OUTCOME MEASURES: Acute lateral ankle ligamentous sprain recurrences and residual symptoms. RESULTS: A total of 44 patients were included, with an average follow-up period after the initial ankle sprain of 204 weeks (range 150-274 weeks). Eight patients (18.1%) had reinjured their ankle. Explicit pain around the ankle joint at physical examination was experienced by 45.5%. Clinical symptoms of anterior ankle impingement were present in 25% (all athletes), with radiologically confirmed tibiotalar osteophyte bone formation in 82% of them. CONCLUSIONS: A large proportion of patients with ALALS experience recurrences and persistent symptoms after their initial ankle injury. The high percentage of patients with anterior ankle impingement syndromes illustrates the need for early assessment of this impairment in patients with persistent complaints.

Feasibility of Exercise Training in Cancer Patients Scheduled for Elective Gastrointestinal Surgery.

BACKGROUND/AIMS: This study examines the feasibility of a preoperative exercise program to improve the physical fitness of a patient before gastrointestinal surgery. METHODS: An outpatient exercise program was developed to increase preoperative aerobic capacity, peripheral muscle endurance and respiratory muscle function in patients with pancreatic, liver, intestinal, gastric or esophageal cancer. During a consult at the outpatient clinic, patients were invited to participate in the exercise program when their surgery was not scheduled within 2 weeks. RESULTS: The 115 participants followed on average 5.7 (3.5) training sessions. Adherence to the exercise program was high: 82% of the planned training sessions were attended, and no adverse events occurred. Mixed model analyses showed a significant increase of maximal inspiratory muscle strength (84.1-104.7 cm H2O; p = 0.00) and inspiratory muscle endurance (35.0-39.5 cm H2O; p = 0.00). No significant changes were found in aerobic capacity and peripheral muscle strength. CONCLUSION: This exercise program in patients awaiting oncological surgery is feasible in terms of participation and adherence. Inspiratory muscle function improved significantly as a result of inspiratory muscle training. The exercise program however failed to result in improved aerobic capacity and peripheral muscle strength, probably due to the limited number of training sessions as a result of the restricted time interval between screening and surgery.

The medial tibial stress syndrome score: a new patient-reported outcome measure.

BACKGROUND: At present, there is no validated patient-reported outcome measure (PROM) for patients with medial tibial stress syndrome (MTSS). AIM: Our aim was to select and validate previously generated items and create a valid, reliable and responsive PROM for patients with MTSS: the MTSS score. METHODS: A prospective cohort study was performed in multiple sports medicine, physiotherapy and military facilities in the Netherlands. Participants with MTSS filled out the previously generated items for the MTSS score on 3 occasions. From previously generated items, we selected the best items. We assessed the MTSS score for its validity, reliability and responsiveness. RESULTS: The MTSS score was filled out by 133 participants with MTSS. Factor analysis showed the MTSS score to exhibit a single-factor structure with acceptable internal consistency (α=0.58) and good test-retest reliability (intraclass correlation coefficient=0.81). The MTSS score ranges from 0 to 10 points. The smallest detectable change in our sample was 0.69 at the group level and 4.80 at the individual level. Construct validity analysis showed significant moderate-to-large correlations (r=0.34-0.52, p<0.01). Responsiveness of the MTSS score was confirmed by a significant relation with the global perceived effect scale (ß=-0.288, R(2)=0.21, p<0.001). CONCLUSIONS: The MTSS score is a valid, reliable and responsive PROM to measure the severity of MTSS. It is designed to evaluate treatment outcomes in clinical studies.

Short-Term Absenteeism and Health Care Utilization Due to Lower Extremity Injuries Among Novice Runners: A Prospective Cohort Study.

OBJECTIVE: To describe absenteeism and health care utilization (HCU) within 6 weeks after occurrence of running-related injuries (RRIs) among novice runners and to explore differences relating to injury and personal characteristics. DESIGN: Prospective cohort study. SETTING: Primary care. PARTICIPANTS: One thousand six hundred ninety-six novice runners (18-65 years) participating in a 6-week running program ("Start-to-Run"). MAIN OUTCOME MEASURES: Injury characteristics were assessed by weekly training logs and personal characteristics by a baseline questionnaire. Data on absenteeism and HCU were collected using questionnaires at 2 and 6 weeks after the RRI occurred. RESULTS: A total of 185 novice runners (11%) reported an RRI during the 6-week program. Of these injured novice runners, 78% reported absence from sports, whereas only 4% reported absence from work. Fifty-one percent of the injured novice runners visited a health care professional, mostly physical therapists (PTs) rather than physicians. Absenteeism was more common among women than men and was also more common with acute RRIs than gradual-onset RRIs. As regards HCU, both the variety of professionals visited and the number of PT visits were higher among runners with muscle-tendon injuries in the ankle/foot region than among those with other RRIs. CONCLUSIONS: Among novice runners sustaining an RRI during a 6-week running program, over three quarters reported short-term absence from sports, whereas absence from work was very limited, and over half used professional health care. Both absence and HCU are associated with injury characteristics. CLINICAL RELEVANCE: In future running promotion programs (eg in Start-to-Run programs), specific attention should be paid to acute injuries and to muscle-tendon injuries in the ankle/foot region.

Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial.

BACKGROUND: Exercise started shortly after breast cancer diagnosis might prevent or diminish fatigue complaints. The Physical Activity during Cancer Treatment (PACT) study was designed to primarily examine the effects of an 18-week exercise intervention, offered in the daily clinical practice setting and starting within 6 weeks after diagnosis, on preventing an increase in fatigue. METHODS: This multi-centre controlled trial randomly assigned 204 breast cancer patients to usual care (n = 102) or supervised aerobic and resistance exercise (n = 102). By design, all patients received chemotherapy between baseline and 18 weeks. Fatigue (i.e., primary outcome at 18 weeks), quality of life, anxiety, depression, and physical fitness were measured at 18 and 36 weeks. RESULTS: Intention-to-treat mixed linear model analyses showed that physical fatigue increased significantly less during cancer treatment in the intervention group compared to control (mean between-group differences at 18 weeks: -1.3; 95 % CI -2.5 to -0.1; effect size -0.30). Results for general fatigue were comparable but did not reach statistical significance (-1.0, 95%CI -2.1; 0.1; effect size -0.23). At 18 weeks, submaximal cardiorespiratory fitness and several muscle strength tests (leg extension and flexion) were significantly higher in the intervention group compared to control, whereas peak oxygen uptake did not differ between groups. At 36 weeks these differences were no longer statistically significant. Quality of life outcomes favoured the exercise group but were not significantly different between groups. CONCLUSIONS: A supervised 18-week exercise programme offered early in routine care during adjuvant breast cancer treatment showed positive effects on physical fatigue, submaximal cardiorespiratory fitness, and muscle strength. Exercise early during treatment of breast cancer can be recommended. At 36 weeks, these effects were no longer statistically significant. This might have been caused by the control participants' high physical activity levels during follow-up. TRIAL REGISTRATION: Current Controlled Trials ISRCTN43801571, Dutch Trial Register NTR2138. Trial registered on December 9th, 2009.