A Multifactorial Weight Reduction Programme for Children with Overweight and Asthma:A Randomized Controlled Trial

BACKGROUND:There is increasing evidence that obesity is related to asthma development and severity. However, it is largely unknown whether weight reduction can influence asthma management, especially in children. OBJECTIVE:To determine the effects of a multifactorial weight reduction intervention on asthma management in overweight/obese children with (a high risk of developing) asthma. METHODS:An 18-month weight-reduction randomized controlled trial was conducted in 87 children with overweight/obesity and asthma. Every six months, measurements of anthropometry, lung function, lifestyle parameters and inflammatory markers were assessed. Analyses were performed with linear mixed models for longitudinal analyses. RESULTS:After 18 months, the body mass index-standard deviation score decreased by -0.14±0.29 points (p0.05). Asthma features (including asthma control and asthma-related quality of life) and lung function indices (static and dynamic) improved significantly over time in both groups. The FVC% predicted improved over time by 10.1 ± 8.7% in the intervention group (p<0.001), which was significantly greater than the 6.1 ± 8.4% in the control group (p<0.05). CONCLUSIONS & CLINICAL RELEVANCE:Clinically relevant improvements in body weight, lung function and asthma features were found in both the intervention and control group, although some effects were more pronounced in the intervention group (FVC, asthma control, and quality of life). This implies that a weight reduction intervention could be clinically beneficial for children with asthma. TRIAL REGISTRATION:ClinicalTrials.gov NCT00998413

Effectiveness of prolonged use of continuous passive motion (CPM) as an adjunct to physiotherapy following total knee arthroplasty: Design of a randomised controlled trial [ISRCTN85759656]

BACKGROUND: Adequate and intensive rehabilitation is an important requirement for successful Total Knee Arthroplasty. The primary focus of early rehabilitation is ambulation of patients and regaining range of motion in the knee. Although research suggests that Continuous Passive Motion should be implemented in the first rehabilitation phase following surgery, there is substantial debate about the duration of each session and the total period of CPM application and. A Cochrane review on this topic concluded that short-term use of CPM leads to greater short-term range of motion. It also suggested, however, that future research should concentrate on the treatment period during which CPM should be administered. METHODS: In a randomised controlled trial we intend to investigate the efficacy of prolonged use of a continuous passive motion (CPM) device in the home situation as an adjunct to standardised physical therapy. The experimental treatment is compared to standardised physical therapy, in patients with osteoarthritis of the knee undergoing Total Knee Arthroplasty (TKA). Efficacy will be assessed in terms of faster improvements in range of motion and functional recovery. Seventy patients with knee osteoarthritis undergoing TKA and experiencing early postoperative flexion impairment (less than 80° of knee flexion at the time of discharge) will be randomised over two treatment groups, a usual care group and an experimental group The experimental group will receive CPM + physiotherapy for 17 consecutive days after surgery, whereas the usual care group will receive the same treatment during the in-hospital phase (i.e. about four days), followed by physical therapy alone (usual care) in the first two weeks after hospital discharge. From 18 days to three months after discharge, both groups will receive standardised PT. The primary focus of rehabilitation will be functional recovery (e.g. ambulation) and regaining range of motion (ROM) in the knee. DISCUSSION: Because restricted knee ROM affects functional activities, knee ROM and knee function are regarded as the primary indicators of successful TKA. Potential effects of the intervention under study include rapid return of knee flexion accompanied by earlier return to functional activities of daily life. If patients benefit significantly from prolonged CPM use, this treatment should be added to the standard PT treatment at home. We expect the additional home CPM programme to be more effective than the usual physiotherapy programme, resulting in a difference in ROM of at least 5°, 17 days after surgery. This clinically important difference, with a possible flexion ROM of about 100°, is expected to lead to better functioning in activities of daily life, like walking, and earlier ability to cycle. These advantages should result in earlier and increasing independence

Reproducibility of goniometric measurement of the knee in the in-hospital phase following total knee arthroplasty

<p>Abstract</p> <p>Background</p> <p>The objective of the present study was to assess interobserver reproducibility (in terms of reliability and agreement) of active and passive measurements of knee RoM using a long arm goniometer, performed by trained physical therapists in a clinical setting in total knee arthroplasty patients, within the first four days after surgery.</p> <p>Methods</p> <p>Test-retest analysis</p> <p>Setting: University hospital departments of orthopaedics and physical therapy</p> <p>Participants: Two experienced physical therapists assessed 30 patients, three days after total knee arthroplasty.</p> <p>Main outcome measure: RoM measurement using a long-arm (50 cm) goniometer</p> <p>Agreement was calculated as the mean difference between observers ± 95% CI of this mean difference. The intraclass correlation coefficient (ICC) was calculated as a measure of reliability, based on two-way random effects analysis of variance.</p> <p>Results</p> <p>The lowest level of agreement was that for measurement of passive flexion with the patient in supine position (mean difference 1.4°; limits of agreement 16.2° to 19° for the difference between the two observers. The highest levels of agreement were found for measurement of passive flexion with the patient in sitting position and for measurement of passive extension (mean difference 2.7°; limits of agreement -6.7 to 12.1 and mean difference 2.2°; limits of agreement -6.2 to 10.6 degrees, respectively). The ability to differentiate between subjects ranged from 0.62 for measurement of passive extension to 0.89 for measurements of active flexion (ICC values).</p> <p>Conclusion</p> <p>Interobserver agreement for flexion as well as extension was only fair. When two different observers assess the same patients in the acute phase after total knee arthroplasty using a long arm goniometer, differences in RoM of less than eight degrees cannot be distinguished from measurement error. Reliability was found to be acceptable for comparison on group level, but poor for individual comparisons over time.</p

Efficiency of immediate postoperative inpatient physical therapy following total knee arthroplasty: an RCT

BACKGROUND: The main goal of physical therapy treatment (PT) in the clinical stage following total knee arthroplasty (TKA) is to prepare patients for discharge from the hospital as soon as possible after their operation. Although aggressive rehabilitation is believed to be important, evidence of effects of different exercise programmes following TKA is limited. This led to the question whether the intensity of PT (once versus twice daily) following TKA affects short-term recovery, measured as range of motion. METHODS: A randomised controlled trial compared an exercise regimen of two sessions per day with a similar programme administered once daily. Primary outcome measure was ROM. RESULTS: At the time of hospital discharge, there was no difference between the experimental and control groups in range of motion. CONCLUSION: This study shows that in our setting twice daily PT sessions do not produce different results as daily PT sessions. It may be questioned whether multiple daily therapy sessions are needed as an in-hospital PT regimen in OA total knee patients

Effectiveness of prolonged use of continuous passive motion (CPM), as an adjunct to physiotherapy, after total knee arthroplasty

<p>Abstract</p> <p>Background</p> <p>Adequate and intensive rehabilitation is an important requirement for successful total knee arthroplasty.</p> <p>Although research suggests that Continuous Passive Motion (CPM) should be implemented in the first rehabilitation phase after surgery, there is substantial debate about the duration of each session and the total period of CPM application. A Cochrane review on this topic concluded that short-term use of CPM leads to greater short-term range of motion. It also suggested, however, that future research should concentrate on the treatment period during which CPM should be administered.</p> <p>Methods</p> <p>In a randomised controlled trial we investigated the effectiveness of prolonged CPM use in the home situation as an adjunct to standardised PT. Efficacy was assessed in terms of faster improvements in range of motion (RoM) and functional recovery, measured at the end of the active treatment period, 17 days after surgery.</p> <p>Sixty patients with knee osteoarthritis undergoing TKA and experiencing early postoperative flexion impairment were randomised over two treatment groups. The experimental group received CPM + PT for 17 consecutive days after surgery, whereas the usual care group received the same treatment during the in-hospital phase (i.e. about four days), followed by PT alone (usual care) in the first two weeks after hospital discharge.</p> <p>From 18 days to three months after surgery, both groups received standardised PT. The primary focus of rehabilitation was functional recovery (e.g. ambulation) and regaining RoM in the knee.</p> <p>Results</p> <p>Prolonged use of CPM slightly improved short-term RoM in patients with limited RoM at the time of discharge after total knee arthroplasty when added to a semi-standard PT programme. Assessment at 6 weeks and three months after surgery found no long-term effects of this intervention Neither did we detect functional benefits of the improved RoM at any of the outcome assessments.</p> <p>Conclusion</p> <p>Although results indicate that prolonged CPM use might have a small short-term effect on RoM, routine use of prolonged CPM in patients with limited RoM at hospital discharge should be reconsidered, since neither long-term effects nor transfer to better functional performance was detected.</p> <p>Trial Registration</p> <p>ISRCTN85759656</p

The daily practice of direct oral anticoagulant use in patients with atrial fibrillation; an observational cohort study

BackgroundDirect oral anticoagulants (DOACs) are administered in fixed doses without monitoring. There is still little published data on the impact of the absence of monitoring on adherence to medication and stability of DOAC plasma levels over time.ObjectivesTo explore adherence and stability of DOAC plasma levels over time in patients with atrial fibrillation (NVAF) recently started on DOAC therapy.Patients and methodsA prospective observational cohort study with structured follow up including assessment of adherence to medication, plasma levels at baseline, 3,6 and 12 months and adverse events.ResultsWe included 164 patients; 89% were previous users of a vitamin K antagonist (VKA). One-year adherence was reasonably good: Morisky adherence measurement scores of 6-8 in 92%. The majority of DOAC plasma levels were within reported on-therapy ranges; dabigatran (median 104.4 ng/ml, IQR 110.2), rivaroxaban (median 185.2 ng/ml, IQR 216.1) and on average levels were not different for full and adjusted doses. There was significant variation between patients, but no significant differences over time within individuals. A substantial proportion of patients starting in the upper-or lower 20th percentiles remained there during the entire follow up. Seventeen bleedings (16 minor, 1 major) were reported, no ischemic events and bleeding or thrombotic events were not associated with DOAC plasma levels.ConclusionsAdherence was reasonably good in the majority of patients. Our data confirm the stability of DOAC plasma levels over time. Knowledge of such data may, in the individual patient, contribute to optimal drug and dose selection

Correction: A Multifactorial Weight Reduction Programme for Children with Overweight and Asthma: A Randomized Controlled Trial (vol 11, e0157158, 2016): (vol 11, e0157158, 2016)

[This corrects the article DOI: 10.1371/journal.pone.0157158.]

Detecting clinically relevant rivaroxaban or dabigatran levels by routine coagulation tests or thromboelastography in a cohort of patients with atrial fibrillation

Abstract Background Traditional coagulation tests are included in emergency guidelines for management of patients on direct oral anticoagulants (DOACs) who experience acute bleeding or require surgery. We determined the ability of traditional coagulation tests and fast whole blood thromboelastography (ROTEM®) to screen for anticoagulation activity of dabigatran and rivaroxaban as low as 30 ng/mL. Methods One hundred eighty-four citrated blood samples (75 dabigatran, 109 rivaroxaban) were collected from patients with non-valvular atrial fibrillation (NVAF), to perform screening tests from different manufacturers, (diluted, D) PT, aPTT, TT and ROTEM®. The activity of DOACs was quantitatively determined by clot detection assays: Hemoclot DTT and DiXaI test (Biophen), on CS2100 (Siemens). The clotting time (CT) of INTEM and EXTEM ROTEM® (Werfen) were used as test parameters. Results Dabigatran, ≥ 30 ng/mL, was accurately detected by five coagulation tests: APTT Actin FSL (93%), PT Neoplastin (93%), APTT Cephascreen, Thromboclotin, and Thrombin (all 100%), but not by PT Innovin (49%). CT-EXTEM (91%) was sufficiently sensitive, but not CT-INTEM (52%). APTT Cephascreen and Thrombin showed good linearity (R2 = 0.71,R2 = 0.72). For the other tests linearity was moderate to poor. Rivaroxaban was accurately detected by PT Neoplastin (98%) and less so by APTT Cephascreen (85%). In addition, rivaroxaban was also accurately detected by CT-INTEM (96%). PT Neoplastin showed good linearity (R2 = 0.81), all other tests had moderate to poor linearity. Conclusion In patients with NVAF, the ability of routine coagulation tests to detect the presence of significant levels of DOACs is test and reagent dependent. CT-INTEM and CT-EXTEM may be fast whole blood alternatives. Trial registration The Institutional Review Board of the MUMC approved this study (December 2011, project number 114069)