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Abstract Background Standard care for anterior cruciate ligament (ACL) injuries often includes surgical reconstruction of the ACL. However, two randomized controlled trials [1, 2] (RCT) concluded that conservative treatment does not result in inferior clinical outcomes compared to immediate ACL reconstruction. More research is needed to verify these results and assess whether patient-specific parameters determine if a patient would benefit from one treatment option over the other. Methods This is a pragmatic, multi-center RCT with two parallel groups. Patients with an acute ACL injury will be recruited from Belgian hospitals. Patients will be randomized to conservative treatment (rehabilitation + optional delayed surgery) or immediate ACL reconstruction (

Introduction Standard care for anterior cruciate ligament (ACL) injuries includes surgical reconstruction of the ACL. However, two randomised controlled trials (RCTs) concluded that conservative treatment does not result in inferior clinical outcomes compared with immediate ACL reconstruction. More research is needed to in the first place verify these results, and second to assess whether patient-specific parameters determine whether a patient would benefit from one treatment option over the other. However, before running a full RCT, it seems necessary to perform a pilot study that assesses the feasibility of recruiting patients with ACL for such a RCT. This is because recruitment may be challenging as many patients have strong treatment beliefs. Therefore, this pilot study will assess whether a large RCT is feasible with regard to participant recruitment, adherence to the allocated treatment arm and protocol feasibility. These pilot findings will help deciding about progressing to a future full RCT.Methods and analysis This is a pragmatic, multicentre, randomised controlled pilot trial with two parallel groups. Patients with an acute ACL injury will be recruited from two Belgian hospitals. Patients will be randomised to either conservative treatment or surgical treatment. Patients will be followed-up at 3, 6 and 12 months postrandomisation. Recruitment feasibility will be evaluated by calculating the recruitment rate 4 months after the two sites have been initiated. Clear criteria for progression to a full trial are defined. Adherence to the protocol will be assessed by calculating the proportion of patients who complete the assessments. Furthermore the proportion of patients who cross-over between treatment arms during the follow-up period will be assessed.Ethics and dissemination The study was approved by the ethical committees: Ethische Commissie Onderzoek UZ/KU Leuven (S62004) and Comité d’Ethique Hospitalo-Facultaire Universitaire de Liège (2020212). Results will be made available to caregivers, researchers and funder.Trial registration number This trial is registered on ClinicalTrials.gov (NCT04408690) on 29 May 2020.

Sufficient physical activity after breast cancer treatment is crucial for improvement of a wide range of health-related outcomes and survival. The first aim of this pilot study was to explore whether adding supervised hydrotherapy sessions to a standard 12-week exercise program consisting of already two supervised sessions of land-based exercises has beneficial effects on physical and mental functioning and quality of life in breast cancer survivors. As a secondary aim, the added value of a third supervised training session with land-based exercises to the same standard exercise program was investigated. Breast cancer patients who finished primary cancer treatment were allocated to one of the three 12-week exercise programs, i.e. a standard exercise program with two supervised land-based exercise sessions per week (control group) or the same standard program with an additional weekly supervised hydrotherapy session (hydrotherapy-group) or land-based exercise session (land-based exercise group). The efficacy of the three programs was tested by comparing changes in physical and mental functioning and quality of life from pre- until post-intervention. Twenty-six (41%) patients were allocated to the control group, 21 (33%) to the hydrotherapy-group and 16 (26%) to the land-based exercise group. The results show no differences in any outcome between the three groups. Comparing the two exercise programs with three supervised sessions, results show a significantly larger improvement in the self-reported moderate (median (IQR) +1240 (412;3330) vs. +50(-1088;1125);p=0.020) and total physical activity level (+2982 (878;5457) vs. +370(-576;1718);p=0.008) in the hydrotherapy-group compared to the land-based exercise group. The opposite was found for the outcome ‘physical symptoms’, a subscale from the health-related quality of life questionnaire with a larger improvement in the land-based exercise group compared to the hydrotherapy-group (+3(0.6;4.8) vs. +0.6(-0.8;2.1); p=0.008). In conclusion, the results of this pilot study indicate that adding a third weekly supervised session to a 12-week exercise program consisting of already two weekly supervised sessions had no added value for the improvement of physical and mental functioning and quality of life after breast cancer treatment. If a third supervised session is organized, hydrotherapy may be a valuable exercise modality since moderate and total physical activity levels seem to improve more compared to an exercise program with three supervised land-based exercise sessions. For self-reported physical symptoms although, a land-based exercise program seems more beneficial. Because of the limited sample size and pilot study design all obtained findings need to be interpreted with caution.

Late-onset Pompe disease (LOPD) is a rare, progressive disorder characterized by limb–girdle muscle weakness and/or respiratory insufficiency, caused by acid alpha-glucosidase (GAA) gene mutations and treated with enzyme replacement therapy. We studied isometric muscle strength in eight muscle groups bilaterally using a Biodex® dynamometer, as well as the Medical Research Council sum score (MRC-SS), hand grip strength, 6 min walk distance (6MWD), 10 m walk test (10MWT) and timed up-and-go test (TUG) in 12 adult, ambulatory, treated LOPD patients and 12 age-/gender-matched healthy controls, every 6 months for 2 years. The mean isometric muscle strength showed a significant decline in right and left knee extensors at 12 months in controls (p < 0.014; p < 0.016), at 18 months in patients (p < 0.010; p < 0.007) and controls (only right side, p < 0.030) and at 24 months in both groups (p < 0.035). The mean 6MWD in patients significantly decreased after 24 months, from 451.9 m to 368.1 m (p < 0.003), whereas in controls, the mean 6MWD significantly increased after 6 months (p < 0.045) and 18 months (p < 0.020) (at 24 months p = 0.054). In patients and controls, the MRC-SS, hand grip test, 10MWT and TUG did not show significant changes (p > 0.05). We conclude that the 6MWD is a useful outcome measure to detect motor decline in treated LOPD patients.