scholarly journals A word of hope for ataxia trials in COVID-19 time and beyond

2020 ◽  
Author(s):  
Roderick P. P. W. M. Maas ◽  
Jordache Ramjith ◽  
Thomas Klockgether ◽  
Kit C. B. Roes ◽  
Bart P. C. van de Warrenburg
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Evaluation ◽  
Primary Endpoint ◽  
Controlled Trial ◽  
Video Recording ◽  
Long Term Outcomes ◽  
Home Video ◽  
Randomized Controlled

Abstract The coronavirus disease 2019 (COVID-19) crisis confronted us, like many researchers worldwide, with an unforeseen challenge during the final stages of a randomized controlled trial involving ataxia patients. Institutional guidelines suddenly no longer allowed regular follow-up visits to take place, impeding the clinical evaluation of long-term outcomes. Here, we discuss the various scenarios that we considered in response to these imposed restrictions and share our experience of home video recording by dedicated, extensively instructed family members. Albeit somewhat unconventional at first glance, this last resort strategy enabled us to reliably assess the study’s primary endpoint at the predefined point in time and hopefully encourages researchers in other ongoing ataxia trials to continue their activities. Remote assessments of ataxia severity may serve as a reasonable substitute in interventional trials beyond the current exceptional situation generated by the COVID-19 pandemic, but will require further investigation.

scholarly journals Long-term outcomes of acute treatment with cognitive therapy v. interpersonal psychotherapy for adult depression: follow-up of a randomized controlled trial

2018 ◽  
Vol 49 (3) ◽  
pp. 465-473 ◽  
Author(s):  
Lotte H.J.M. Lemmens ◽  
Suzanne C. van Bronswijk ◽  
Frenk Peeters ◽  
Arnoud Arntz ◽  
Steven D. Hollon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Therapy ◽  
Controlled Trial ◽  
Total Sample ◽  
Prophylactic Effect ◽  
Long Term Outcomes ◽  
Treatment Termination ◽  
Randomized Controlled

AbstractBackgroundAlthough equally efficacious in the acute phase, it is not known how cognitive therapy (CT) and interpersonal psychotherapy (IPT) for major depressive disorder (MDD) compare in the long run. This study examined the long-term outcomes of CT v. IPT for MDD.MethodsOne hundred thirty-four adult (18–65) depressed outpatients who were treated with CT (n = 69) or IPT (n = 65) in a large open-label randomized controlled trial (parallel group design; computer-generated block randomization) were monitored across a 17-month follow-up phase. Mixed regression was used to determine the course of self-reported depressive symptom severity (Beck Depression Inventory II; BDI-II) after treatment termination, and to test whether CT and IPT differed throughout the follow-up phase. Analyses were conducted for the total sample (n = 134) and for the subsample of treatment responders (n = 85). Furthermore, for treatment responders, rates of relapse and sustained response were examined for self-reported (BDI-II) and clinician-rated (Longitudinal Interval Follow-up Evaluation; LIFE) depression using Cox regression.ResultsOn average, the symptom reduction achieved during the 7-month treatment phase was maintained across follow-up (7–24 months) for CT and IPT, both in the total sample and in the responder sample. Two-thirds (67%) of the treatment responders did not relapse across the follow-up period on the BDI-II. Relapse rates assessed with the LIFE were somewhat lower. No differential effects between conditions were found.ConclusionsPatients who responded to IPT were no more likely to relapse following treatment termination than patients who responded to CT. Given that CT appears to have a prophylactic effect following successful treatment, our findings suggest that IPT might have a prophylactic effect as well.

scholarly journals Endothelial Dysfunction, Atherosclerosis, and Increase of von Willebrand Factor and Factor VIII: A Randomized Controlled Trial in Swine

2021 ◽  
Author(s):  
Ferdows Atiq ◽  
Jens van de Wouw ◽  
Oana Sorop ◽  
Ilkka Heinonen ◽  
Moniek P. M. de Maat ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Randomized Controlled Trial ◽  
Endothelial Dysfunction ◽  
Controlled Trial ◽  
Short Term ◽  
Randomized Controlled ◽  
Von Willebrand ◽  
Willebrand Factor

AbstractIt is well known that high von Willebrand factor (VWF) and factor VIII (FVIII) levels are associated with an increased risk of cardiovascular disease. It is still debated whether VWF and FVIII are biomarkers of endothelial dysfunction and atherosclerosis or whether they have a direct causative role. Therefore, we aimed to unravel the pathophysiological pathways of increased VWF and FVIII levels associated with cardiovascular risk factors. First, we performed a randomized controlled trial in 34 Göttingen miniswine. Diabetes mellitus (DM) was induced with streptozotocin and hypercholesterolemia (HC) via a high-fat diet in 18 swine (DM + HC), while 16 healthy swine served as controls. After 5 months of follow-up, FVIII activity (FVIII:C) was significantly higher in DM + HC swine (5.85 IU/mL [5.00–6.81]) compared with controls (4.57 [3.76–5.40], p = 0.010), whereas VWF antigen (VWF:Ag) was similar (respectively 0.34 IU/mL [0.28–0.39] vs. 0.34 [0.31–0.38], p = 0.644). DM + HC swine had no endothelial dysfunction or atherosclerosis during this short-term follow-up. Subsequently, we performed a long-term (15 months) longitudinal cohort study in 10 Landrace–Yorkshire swine, in five of which HC and in five combined DM + HC were induced. VWF:Ag was higher at 15 months compared with 9 months in HC (0.37 [0.32–0.42] vs. 0.27 [0.23–0.40], p = 0.042) and DM + HC (0.33 [0.32–0.37] vs. 0.25 [0.24–0.33], p = 0.042). Both long-term groups had endothelial dysfunction compared with controls and atherosclerosis after 15 months. In conclusion, short-term hyperglycemia and dyslipidemia increase FVIII, independent of VWF. Long-term DM and HC increase VWF via endothelial dysfunction and atherosclerosis. Therefore, VWF seems to be a biomarker for advanced cardiovascular disease.

scholarly journals Results Are Similar Two Years After Acute or Delayed Anterior Cruciate Ligament Reconstruction. A Randomized Controlled Trial

2017 ◽  
Vol 5 (5_suppl5) ◽  
pp. 2325967117S0017
Author(s):  
Karl Eriksson ◽  
Christoffer von Essen ◽  
Björn Barenius
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Endpoint ◽  
Pivot Shift ◽  
Controlled Trial ◽  
Acl Injury ◽  
Activity Level ◽  
Randomized Controlled ◽  
Delayed Group ◽  
The Mean

Objectives: Acute ACLR has been avoided since the 1990’s due to reports of postoperative stiffness. But are these risks still valid with modern arthroscopic techniques? The aim of this randomized controlled trial was to assess the impact of the time between injury and reconstruction on the outcome after ACLR. Our hypothesis was that acute ACLR with semitendinosus graft can be performed safely. Methods: The primary endpoint was ROM at three months after surgery. A power calculation revealed the need for 64 patients to detect a ROM difference of 5 degrees between the groups (5% significance level). 70 patients with a high recreational activity level (Tegner ≥6) who presented with an acute ACL injury were randomized to an acute reconstruction within 8 days from the injury or delayed reconstruction (after normalized ROM) 6-10 weeks after the injury. Fixation was with Endobutton in femur and a metallic interference screw in tibia. The rehabilitation was performed at the same physiotherapy center for all patients. Follow up assessment was performed by a physiotherapist not involved with the rehabilitation. The follow up at 24 months included ROM, Lachman, instrumented laxity with Rolimeter, pivot shift, one leg hop index, Biodex, IKDC, KOOS, Lysholm and Tegner Activity level, and a VAS question regarding knee function and the knee function’s effect on activity level. Results: Seventy percent of the patients were males, mean age at the time of surgery was 27 years (18 -41) and the median pre-injury Tegner level was 9 (6-10) with no differences between the groups. 64 (91%) patients were assessed at three months with no difference according to the primary endpoint. Median Tegner level was restored to pre-injury levels in both groups after one year, and did not change between one and two years. 63 (90%) patients were available for the 2-year follow up. There was one graft rupture and one contralateral ACL injury in both groups. There was additional surgery in 15% of the acute patients and in 31% in the delayed (n.s.). The mean instrumented laxity was 1.8 mm in the acute and 2.0 in the delayed group. There were no positive pivot shift in the acute group and 6 patients with grade 1 or not possible to perform in the delayed group (p=0.039). IKDC revealed no significant differences between the groups. Lysholm score was 87 in both groups. KOOS values showed no significant difference between the groups. VAS response to the question “How is your knee working on a scale from 0-100? (100 = best)” was 81 in the acute and 71 in the delayed group (p=0.1) and “How does your knee affect your activity level? (100 = no affection)” the mean score was 75 in the acute and 67 in the delayed group (p=0.3). Functional strength (one leg hop index >90%) was 85% in the acute and 67% in the delayed group (n.s). Conclusion: We found no increased risk of arthrofibrosis after acute ACLR. Good results can be achieved at two years regardless of ROM and swelling in the acute stage.

scholarly journals Long-Term Effects of Resistance Exercise Training on Cognition and Brain Volume in Older Women: Results from a Randomized Controlled Trial

2015 ◽  
Vol 21 (10) ◽  
pp. 745-756 ◽  
Author(s):  
John R. Best ◽  
Bryan K. Chiu ◽  
Chun Liang Hsu ◽  
Lindsay S. Nagamatsu ◽  
Teresa Liu-Ambrose
Keyword(s):  
Randomized Controlled Trial ◽  
White Matter ◽  
Resistance Training ◽  
Exercise Training ◽  
Older Women ◽  
Controlled Trial ◽  
Resistance Exercise Training ◽  
Randomized Controlled

AbstractAerobic exercise training has been shown to attenuate cognitive decline and reduce brain atrophy with advancing age. The extent to which resistance exercise training improves cognition and prevents brain atrophy is less known, and few studies include long-term follow-up cognitive and neuroimaging assessments. We report data from a randomized controlled trial of 155 older women, who engaged in 52 weeks of resistance training (either once- or twice-weekly) or balance-and-toning (twice-weekly). Executive functioning and memory were assessed at baseline, 1-year follow-up (i.e., immediately post-intervention), and 2-year follow-up. A subset underwent structural magnetic resonance imaging scans at those time points. At 2-year follow-up, both frequencies of resistance training promoted executive function compared to balance-and-toning (standardized difference [d]=.31–.48). Additionally, twice-weekly resistance training promoted memory (d=.45), reduced cortical white matter atrophy (d=.45), and increased peak muscle power (d=.27) at 2-year follow-up relative to balance-and-toning. These effects were independent of one another. These findings suggest resistance training may have a long-term impact on cognition and white matter volume in older women. (JINS, 2015,21, 745–756)

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