Feasibility of a home-based exercise intervention with remote guidance for patients with stable grade II and III gliomas: a pilot randomized controlled trial.

OBJECTIVE: In this pilot study, we investigated the feasibility of a home-based, remotely guided exercise intervention for patients with gliomas. DESIGN: Pilot randomized controlled trial (RCT) with randomization (2:1) to exercise or control group. SUBJECTS: Patients with stable grade II and III gliomas. INTERVENTION: The six-month intervention included three home-based exercise sessions per week at 60%-85% of maximum heart rate. Participants wore heart rate monitors connected to an online platform to record activities that were monitored weekly by the physiotherapist. MAIN MEASURES: Accrual, attrition, adherence, safety, satisfaction, patient-reported physical activity, VO2 peak (by maximal cardiopulmonary exercise testing) and body mass index (BMI) at baseline and at six-month follow-up. RESULTS: In all, 34 of 136 eligible patients (25%) were randomized to exercise training ( N = 23) or the control group ( N = 11), of whom 19 and 9, respectively, underwent follow-up. Mean adherence to prescribed sessions was 79%. Patients' experiences were positive. There were no adverse events. Compared to the control group, the exercise group showed larger improvements in absolute VO2 peak (+158.9 mL/min; 95% CI: -44.8 to 362.5) and BMI (-0.3 kg/m²; 95% CI: -0.9 to 0.2). The median increase in physical activity was 1489 metabolic equivalent of task (MET) minutes higher in the exercise group. The most reported reasons for non-participation were lack of motivation or time. CONCLUSION: This innovative and intensive home-based exercise intervention was feasible in a small subset of patients with stable gliomas who were interested in exercising. The observed effects suggest that the programme may improve cardiorespiratory fitness. These results support the need for large-scale trials of exercise interventions in brain tumour patients.

Interventions preventing ankle sprains; previous injury and high-risk sport participation as predictors of compliance.

OBJECTIVES: To describe the association between participants' person-related potential predictor variables and cumulative compliance with interventions for preventing ankle sprains: neuromuscular training, wearing an ankle brace, and a combined training and bracing. DESIGN: Secondary analysis of compliance data from a randomized controlled trial (RCT) comparing measures preventing ankle ligament injuries. METHODS: Ordinal regression with a backward selection method was used to obtain a descriptive statistical model linking participants' person-related potential predictor variables with the monthly cumulative compliance measurements for three interventions preventing ankle ligament injuries. RESULTS: Having had a previous ankle injury was significantly associated with a higher compliance with all of the preventive measures trialed. Overall compliance with bracing and the combined intervention was significantly lower than the compliance with NM training. Per group analysis found that participating in a high-risk sport, like soccer, basketball, and volleyball, was significantly associated with a higher compliance with bracing, or a combined bracing and NM training. In contrast, participating in a high-risk sport was significantly associated with a lower per group compliance with NM training. CONCLUSIONS: Future studies should include at least registration of previous ankle sprains, sport participation (high- or low-risk), experience in NM training, and hours of sport exposure as possible predictors of compliance with interventions preventing ankle sprains. Practitioners should take into account these variables when prescribing preventive neuromuscular training or bracing.

The Cost-Effectiveness of Measures to Prevent Recurrent Ankle Sprains: Results of a 3-Arm Randomized Controlled Trial.

BACKGROUND: Ankle sprains are the most common sports-related injury, associated with a high rate of recurrence and societal costs. Recent studies have emphasized the effectiveness of both neuromuscular training and bracing for the secondary prevention of ankle sprains. PURPOSE: To evaluate the cost-effectiveness of the separate and combined use of bracing and neuromuscular training for the prevention of the recurrence of ankle sprains. STUDY DESIGN: Economic and decision analysis; Level of evidence, 2. METHODS: A total of 340 athletes (157 male and 183 female; aged 12-70 years) who had sustained a lateral ankle sprain up to 2 months before inclusion were randomized to a neuromuscular training group (n = 107), brace group (n = 113), and combined intervention group (n = 120). Randomization was stratified by medical treatment of the inclusion sprain. Participants in the neuromuscular training group underwent an 8-week home-based exercise program. Participants in the brace group received a semirigid ankle brace to be worn during all sports activities for a period of 12 months. Participants allocated to the combined group underwent both interventions, with the ankle brace to be worn during all sports activities for a period of 8 weeks. The recurrence of ankle sprains and associated costs were registered during the 1-year follow-up. RESULTS: There were no differences between groups at baseline with regard to age, sex, sports participation, previous injury, or knowledge of preventive measures. The incremental cost-effectiveness ratio (ICER) of the brace group in comparison with the combined group was -€2828.30 (approximately--US$3865.00), based on a difference in the mean cost of -€76.16 (approximately--US$104.00) and a difference in the mean effects of 2.68%. The ICER of the neuromuscular training group in comparison with the combined group was €310.08 (approximately US$424.00), based on a difference in the mean cost of -€28.37 (approximately--US$39.00) and a difference in the mean effects of 9.15%. CONCLUSION: Bracing was found to be the dominant secondary preventive intervention over both neuromuscular training and the combination of both measures.

Bracing superior to neuromuscular training for the prevention of self-reported recurrent ankle sprains: a three-arm randomised controlled trial.

BACKGROUND: Ankle sprain is the most common sports-related injury with a high rate of recurrence and associated costs. Recent studies have emphasised the effectiveness of both neuromuscular training and bracing for the secondary prevention of ankle sprains. AIM: To evaluate the effectiveness of combined bracing and neuromuscular training, or bracing alone, against the use of neuromuscular training on recurrences of ankle sprain after usual care. METHODS: 384 athletes, aged 18-70, who had sustained a lateral ankle sprain, were included (training group n=120; brace group n=126; combi group n=138). The training group received an 8-week home-based neuromuscular training programme, the brace group received a semirigid ankle brace to be worn during all sports activities for 12 months, and the combi group received both the training programme, as well as the ankle brace, to be worn during all sports activities for 8 weeks. The main outcome measure was self-reported recurrence of the ankle sprain. RESULTS: During the 1-year follow-up, 69 participants (20%) reported a recurrent ankle sprain: 29 (27%) in the training group, 17 (15%) in the brace group and 23 (19%) in the combi group. The relative risk for a recurrent ankle sprain in the brace group versus the training group was 0.53 (95% CI 0.29 to 0.97). No significant differences were found for time losses or costs due to ankle sprains between the intervention groups. CONCLUSIONS: Bracing was superior to neuromuscular training in reducing the incidence but not the severity of self-reported recurrent ankle sprains after usual care.

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.

Treatment of distal tibial fractures: plate versus nail: a retrospective outcome analysis of matched pairs of patients.

A study of 24 patients who sustained an extra-articular fracture of the distal third of the tibial shaft was performed to determine the effect of the type of treatment, open reduction and internal fixation (ORIF) or closed reduction and intramedullary (IM) nailing, on the occurrence of malalignment. All patients were treated in our clinic between 1993 and 2001 for a fracture in the distal third of the tibia. Twelve patients treated with ORIF were matched to 12 patients treated with IM nailing, with regard to gender, age decade, and the AO classification of the fracture. The group treated with IM nailing was assessed after a mean 6.0 years versus ORIF after a mean of 4.5 years. Two patients treated with ORIF versus six patients treated with IM nailing had a malalignment of the tibia. Furthermore, we found no difference with regard to time to union, non-union, hardware failure or deep infections between ORIF and IM nailing. Our results suggest that control of alignment is difficult with IM nailing of distal tibial fractures. For optimal alignment we advise considering the use of ORIF for closed and type I open extra-articular fractures in the distal third of the tibia.