scholarly journals Protocol for a randomized controlled trial of electroacupuncture in the management of patients with axial spondyloarthritis in Singapore (E‐AcuSpA)

2021 ◽  
Vol 1 (2) ◽  
pp. 104-114
Author(s):  
Warren Fong ◽  
Yu Heng Kwan ◽  
Su‐An Quek ◽  
Ader Lim ◽  
Chiah Yuen Wong ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Axial Spondyloarthritis ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals High-Intensity Exercise Improves Fatigue, Sleep, and Mood in Patients With Axial Spondyloarthritis: Secondary Analysis of a Randomized Controlled Trial

2020 ◽  
Vol 100 (8) ◽  
pp. 1323-1332 ◽  
Author(s):  
Silje Halvorsen Sveaas ◽  
Hanne Dagfinrud ◽  
Inger Jorid Berg ◽  
Sella Arrestad Provan ◽  
Melissa Woll Johansen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Beneficial Effect ◽  
High Intensity ◽  
General Health ◽  
Axial Spondyloarthritis ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Exercise Group ◽  
Control Group ◽  
Randomized Controlled

Abstract Objective Although exercise is recommended in the treatment of axial spondyloarthritis (axSpa), the focus has been on flexibility, and the effect of high-intensity exercises is unknown. The purpose of this study was to investigate the effect of high-intensity exercises on fatigue, sleep, and mood in patients with axSpA. Methods In this secondary analysis of a randomized controlled trial, participants were recruited from outpatient clinics at 4 hospitals in Scandinavia. A total of 100 patients with axSpA were randomized to either an exercise group (n = 50) or a control group (n = 50). High-intensity exercise was provided 3 times per week for 3 months and supervised by a physical therapist. The controls received no intervention. Measurements were self-reported at baseline, 3 months, and 12 months: fatigue, using the Fatigue Severity Scale (range = 0–7, 7 = worst, ≥5 = severe); vitality, using the RAND 36-item short-form health survey (SF-36, range = 0–100, 100 = best); sleep, using the Pittsburgh Sleep Quality Index (range = 0–21, 21 = worst, >5 = poor quality); mood, using the General Health Questionnaire 12 (range = 0–36, 36 = worst); and general health, using the EUROQoL (range = 0–100, 100 = best). Results A total of 38 participants (76%) in the exercise group followed ≥80% of the exercise protocol. At 3 months, there was a significant beneficial effect on fatigue (mean group differences = −0.4, 95% CI = −0.7 to −0.1), vitality (5.0, 95% CI = 1.1 to 10.5), mood (−2, 95% CI = −3.7 to −0.04), and general health (9.0, 95% CI = 3.3 to 14.7) but no effect on sleep (−1.1, 95% CI = −2.1 to 0.2). Compared with the control group, the exercise group had a reduced rate of severe fatigue and poor sleep. No differences were seen between the groups at 12 months. Conclusions A 3-month exercise program had a beneficial effect on fatigue, sleep, mood, and general health in patients with axSpA at the end of the intervention; however, no long-term effects were seen. Impact High-intensity cardiorespiratory and strength exercises should be considered as important in exercise programs for patients with axSpA.

scholarly journals Serial locally applied water-filtered infrared a radiation in axial spondyloarthritis – a randomized controlled trial

2020 ◽  
Vol 37 (1) ◽  
pp. 965-970
Author(s):  
Philipp Klemm ◽  
Markus Eichelmann ◽  
Iris Aykara ◽  
Ole Hudowenz ◽  
Gabriel Dischereit ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Axial Spondyloarthritis ◽  
Controlled Trial ◽  
Applied Water ◽  
Randomized Controlled

scholarly journals The IMPACT study: A clustered randomized controlled trial to assess the effect of a referral algorithm for axial spondyloarthritis

PLoS ONE ◽  
2020 ◽  
Vol 15 (1) ◽  
pp. e0227025 ◽  
Author(s):  
Maha Jamal ◽  
Amber M. Korver ◽  
Martijn Kuijper ◽  
Deirisa Lopes Barreto ◽  
Cathelijne W. Y. Appels ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Axial Spondyloarthritis ◽  
Controlled Trial ◽  
Impact Study ◽  
Randomized Controlled ◽  
The Impact

scholarly journals OP0138 FEASIBILITY OF PROGRESSIVE ANTI-TNF TAPERING IN AXIAL SPONDYLOARTHRITIS PATIENTS IN LOW DISEASE ACTIVITY: RESULTS FROM THE MULTICENTER NON-INFERIORITY PROSPECTIVE RANDOMIZED CONTROLLED TRIAL SPACING

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 80.1-81
Author(s):  
C. Lukas ◽  
A. Tournadre ◽  
M. C. Picot ◽  
E. Nogué ◽  
E. Dernis ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Controlled Trial ◽  
Research Support ◽  
Low Disease Activity ◽  
Randomized Controlled ◽  
The Difference ◽  
Activity State

Background:Anti-TNF treatments (TNFi) have shown high efficacy in axial spondyloarthritis (ax-SpA) with inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs). However their effect remains predominantly symptomatic, and their long-term tolerance as well as significant societal cost justify investigation about a potential reduction in drug dosage, or –most feasible and comfortable for the patient– increase in intervals between doses.Objectives:To assess if a progressive and monitored reduction of administered TNFi by increase of intervals between injections results in a comparable proportion of patients remaining after 12 months (m) in low disease activity state despite a decreased cumulative treatment dose received.Methods:Non-inferiority randomized controlled trial, having included adult patients with ax-SpA fulfilling ASAS criteria, already treated by anti-TNF, and in stable low disease activity for at least 6 m (current and at least 6 m old BASDAI<4/10), who were randomized into 2 groups: either keeping on their usual treatment with stable doses (“unchanged” group), or progressive spacing of injections of their treatment (“spacing” group). Follow-up was done every 3 m during 12 m, with regular monitoring of disease activity and, in patients from the group “spacing”, modification of the rhythm of injections according to disease activity and predefined standardized protocol (either increase or decrease (step-back) of intervals between injections). The primary endpoint was the difference of proportions of patients having a low disease activity state (BASDAI<4/10) after 12 m of follow-up between the 2 groups. It was estimated on the ITT population after multiple imputation. The 90% confidence interval associated was calculated using the Farrington-Manning method and the lower bound was compared to the non-inferiority margin of -20%. With an expected proportion of 85% patients remaining in low disease activity in the unchanged group, and α and β risks at respectively 5% and 90%, the required number of patients was calculated at 358, and thus 398 had to be included with a 10% expected proportion of patients with unavailable data.Results:398 patients were randomized in 23 French rheumatology units (197 and 201 in the spacing and unchanged groups respectively), and 389 included in analyses (9 did not receive the allocated treatment). Mean (SD) age was 44.3 (12.4) years, 71.2% were males. Mean (SD) BASDAI at inclusion was 1.45 (1.02). TNFi used were etanercept (35.7%), adalimumab (33.9%), infliximab (20.6%), golimumab (9.3%) and certolizumab (0.5%). For the 373 patients with complete follow-up (93.7%), 162/184 (88.0%) had a low disease activity in the “spacing” group vs. 173/189 (91.5%) in the “unchanged” group at 12 m. After multiple imputation for the 16 patients with missing data, the difference of proportion between the two groups was estimated to -4.18% [CI90% -10.0; 1.7], thus confirming the non-inferiority of the “spacing” procedure. In the “spacing” group at 12 m, 134/162 (82.7%) patients in low disease activity were still receiving a lowered TNFi dose.Conclusion:In ax-SpA patients with BASDAI<4 for at least 6 months under TNFi, it is possible to increase intervals between injections while maintaining a low disease activity by adjusting treatment with quarterly monitoring of SpA activity.Disclosure of Interests:Cédric Lukas Speakers bureau: Abbvie, Amgen, Janssen, Lilly, MSD, Novartis, Pfizer, Roche-Chugai, UCB, Consultant of: Abbvie, Amgen, Janssen, Lilly, MSD, Novartis, Pfizer, Roche-Chugai, UCB, Grant/research support from: Pfizer, Novartis and Roche-Chugai, Anne Tournadre Speakers bureau: Abbvie, Fresenius, Janssen, MSD, Pfizer, Roche Chugai, Sanofi, Paid instructor for: Fresenius, Consultant of: Abbvie, Fresenius, Lilly, Novartis, Sanofi, Grant/research support from: Fresenius, Novartis, Pfizer, UCB, Marie Christine Picot: None declared, Erika Nogué: None declared, Emmanuelle Dernis Speakers bureau: Roche chugai, UCB, BMS, Novartis, Lilly, Mylan, Pfizer, Celgène, Consultant of: UCB, MSD, BMS, Lilly, Novartis, Philippe Goupille Speakers bureau: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Janssen, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Consultant of: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Janssen, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Grant/research support from: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Janssen, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Bernard Combe Speakers bureau: AbbVie; Bristol-Myers Squibb; Gilead; Janssen; Lilly; Merck; Novartis; Pfizer; Roche-Chugai; and Sanofi, Consultant of: AbbVie; Bristol-Myers Squibb; Gilead; Janssen; Lilly; Merck; Novartis; Pfizer; Roche-Chugai; and Sanofi, Grant/research support from: Novartis, Pfizer, and Roche-Chugai, Jacques Morel Speakers bureau: Abbvie, Biogen, BMS, Fresenius Kabi, Lilly, Mylan, Novartis, Pfizer, Sanofi, Consultant of: Abbvie, BMS, Boerhinger Ingelheim, Galpaagos, GSK, Lilly, Novartis, Sanofi

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

Phonomotor Versus Semantic Feature Analysis Treatment for Anomia in 58 Persons With Aphasia: A Randomized Controlled Trial

2019 ◽  
Vol 62 (12) ◽  
pp. 4464-4482 ◽  
Author(s):  
Diane L. Kendall ◽  
Megan Oelke Moldestad ◽  
Wesley Allen ◽  
Janaki Torrence ◽  
Stephen E. Nadeau
Keyword(s):  
Randomized Controlled Trial ◽  
Response Latency ◽  
Controlled Trial ◽  
Semantic Knowledge ◽  
Semantic Feature ◽  
Feature Analysis ◽  
Group Differences ◽  
Randomized Controlled ◽  
Confrontation Naming ◽  
Semantic Feature Analysis

Purpose The ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session, as well as generalization to untrained exemplars and contexts. The purpose of this study was to test the efficacy of phonomotor treatment, a treatment focusing on enhancement of phonological sequence knowledge, against semantic feature analysis (SFA), a lexical-semantic therapy that focuses on enhancement of semantic knowledge and is well known and commonly used to treat anomia in aphasia. Method In a between-groups randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56–60 hr of intensively delivered treatment over 6 weeks with testing pretreatment, posttreatment, and 3 months posttreatment termination. Results There was no significant between-groups difference on the primary outcome measure (untrained nouns phonologically and semantically unrelated to each treatment) at 3 months posttreatment. Significant within-group immediately posttreatment acquisition effects for confrontation naming and response latency were observed for both groups. Treatment-specific generalization effects for confrontation naming were observed for both groups immediately and 3 months posttreatment; a significant decrease in response latency was observed at both time points for the SFA group only. Finally, significant within-group differences on the Comprehensive Aphasia Test–Disability Questionnaire ( Swinburn, Porter, & Howard, 2004 ) were observed both immediately and 3 months posttreatment for the SFA group, and significant within-group differences on the Functional Outcome Questionnaire ( Glueckauf et al., 2003 ) were found for both treatment groups 3 months posttreatment. Discussion Our results are consistent with those of prior studies that have shown that SFA treatment and phonomotor treatment generalize to untrained words that share features (semantic or phonological sequence, respectively) with the training set. However, they show that there is no significant generalization to untrained words that do not share semantic features or phonological sequence features.

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