scholarly journals High-intensity strength training in patients with idiopathic inflammatory myopathies: a randomised controlled trial protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e043793
Author(s):  
Kasper Yde Jensen ◽  
Per Aagaard ◽  
Henrik Daa Schrøder ◽  
Charlotte Suetta ◽  
Jakob Lindberg Nielsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Muscle Strength ◽  
Strength Training ◽  
High Intensity ◽  
Controlled Trial ◽  
Whole Body ◽  
Secondary Outcome ◽  
Idiopathic Inflammatory Myopathies ◽  
Inflammatory Myopathies ◽  
Randomised Controlled

IntroductionIdiopathic inflammatory myopathies (IIMs) are rare diseases characterised by non-suppurative inflammation of skeletal muscles and muscle weakness. Additionally, IIM is associated with a reduced quality of life. Strength training is known to promote muscle hypertrophy and increase muscle strength and physical performance in healthy young and old adults. In contrast, only a few studies have examined the effects of high intensity strength training in patients with IIM and none using a randomised controlled trial (RCT) set-up. Thus, the purpose of this study is to investigate the effects of high-intensity strength training in patients affected by the IIM subsets polymyositis (PM), dermatomyositis (DM) and immune-mediated necrotising myopathy (IMNM) using an RCT study design.Methods and analysis60 patients with PM, DM or IMNM will be included and randomised into (1) high-intensity strength training or (2) Care-as-Usual. The intervention period is 16 weeks comprising two whole-body strength exercise sessions per week. The primary outcome parameter will be the changes from pre training to post training in the Physical Component Summary measure in the Short Form-36 health questionnaire. Secondary outcome measures will include maximal lower limb muscle strength, skeletal muscle mass, functional capacity, disease status (International Myositis Assessment and Clinical Studies Group core set measures) and questionnaires assessing physical activity levels and cardiovascular comorbidities. Furthermore, blood samples and muscle biopsies will be collected for subsequent analyses.Ethics and disseminationThe study complies with the Helsinki Declaration II and is approved by The Danish Data Protection Agency (P-2020–553). The study is approved by The Danish National Committee on Health Research Ethics (H-20030409). The findings of this trial will be submitted to relevant peer-reviewed journals. Abstracts will be submitted to international conferences.Trial registration numberNCT04486261.

scholarly journals Recovery of early postoperative muscle strength after deep neuromuscular block by means of ultrasonography with comparison of neostigmine versus sugammadex as reversal drugs: study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043935
Author(s):  
Xuan Wang ◽  
Yingyuan Li ◽  
Chanyan Huang ◽  
Wei Xiong ◽  
Qin Zhou ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Muscle Strength ◽  
Neuromuscular Blockade ◽  
Postoperative Period ◽  
Controlled Trial ◽  
Complete Recovery ◽  
Early Postoperative Period ◽  
Time Points ◽  
Muscle Groups ◽  
Randomised Controlled

IntroductionDespite the use of quantitative neuromuscular monitoring together with the administration of reversal drugs (neostigmine or sugammadex), the incidence of residual neuromuscular blockade defined as a train-of-four ratio (TOFr) <0.9 remains high. Even TOFr >0.9 cannot ensure adequate recovery of neuromuscular function when T1 height is not recovered completely. Thus, a mathematical correction of TOFr needs to be applied because the return of a normal TOFr can precede the return of a normal T1 twitch height. On the other hand, different muscles have different sensitivities to neuromuscular blockade agents; thus, complete recovery of one specific muscle group does not represent complete recovery of all other muscles. Therefore, our study aims to assess the muscle strength recovery of respiratory-related muscle groups by ultrasound and evaluate global strength using handgrip dynamometry in the early postoperative period when TOFr=0.9 and corrected TOFr (cTOFr)=0.9 with comparison of neostigmine versus sugammadex as reversal drugs.Methods and analysisThis study will be a prospective, single-blinded, randomised controlled trial involving 60 patients with American Society of Anesthesiologists physical status I–II and aged between 18 and 65 years, who will undergo microlaryngeal surgery. We will assess geniohyoid muscle, parasternal intercostal muscle, diaphragm, abdominal wall muscle and handgrip strength at four time points: before anaesthesia, TOFr=0.9, cTOFr=0.9 and 30 min after admission to the post anaesthesia care unit. Our primary objective will be to compare the effects of neostigmine and sugammadex on the recovery of muscle strength of different muscle groups in the early postoperative period when TOFr=0.9 and cTOFr=0.9. The secondary objective will be to observe the difference of muscle strength between the time points of TOFr=0.9 and cTOFr=0.9 to find out the clinical significance of cTOFr >0.9.Ethics and disseminationThe protocol was reviewed and approved by the Ethics Committee of The First Affiliated Hospital, Sun Yat-sen University. The findings will be disseminated to the public through peer-reviewed scientific journals.Trial registration numberChiCTR2000033832.

scholarly journals The improvement of cognitive deficits after whole-body cryotherapy – A randomised controlled trial

2021 ◽  
Vol 146 ◽  
pp. 111237
Author(s):  
Joanna Rymaszewska ◽  
Katarzyna M. Lion ◽  
Bartłomiej Stańczykiewicz ◽  
Julia E. Rymaszewska ◽  
Elżbieta Trypka ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Deficits ◽  
Controlled Trial ◽  
Whole Body ◽  
Randomised Controlled ◽  
Whole Body Cryotherapy

scholarly journals PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050582
Author(s):  
Annette Mollerup ◽  
Sofus Christian Larsen ◽  
Anita Selmer Bennetzen ◽  
Marius Henriksen ◽  
Mette Kildevaeld Simonsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Hospital Admission ◽  
Usual Care ◽  
Pulmonary Disease ◽  
Controlled Trial ◽  
Self Care ◽  
Secondary Outcome ◽  
Link Type ◽  
Randomised Controlled ◽  
At Home

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; Pre-results.

scholarly journals Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042627
Author(s):  
María Reina-Bueno ◽  
María del Carmen Vázquez-Bautista ◽  
Inmaculada C Palomo-Toucedo ◽  
Gabriel Domínguez-Maldonado ◽  
José Manuel Castillo-López ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Foot Orthoses ◽  
Systemic Lupus ◽  
Custom Made ◽  
Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

scholarly journals Cost-effectiveness analysis of an intimate partner violence prevention intervention targeting men, women and couples in rural Ethiopia: evidence from the Unite for a Better Life randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042365
Author(s):  
Jessica Leight ◽  
Negussie Deyessa ◽  
Vandana Sharma
Keyword(s):  
Intimate Partner Violence ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Partner Violence ◽  
Controlled Trial ◽  
Intimate Partner ◽  
Community Level ◽  
Secondary Outcome ◽  
Randomised Controlled ◽  
The Cost

ObjectivesExperience of intimate partner violence (IPV) is associated with adverse health and psychosocial outcomes for women. However, rigorous economic evaluations of interventions targeting IPV prevention are rare. This paper analyses the cost-effectiveness of Unite for a Better Life (UBL), a gender-transformative intervention designed to prevent IPV and HIV risk behaviours among men, women and couples.DesignWe use an economic evaluation nested within a large-scale cluster randomised controlled trial, analysing financial and economic costs tracked contemporaneously.SettingUBL was implemented in rural southern Ethiopia between 2013 and 2015.ParticipantsThe randomised controlled trial included 6770 households in 64 villages.InterventionsUBL is an intervention delivered within the context of the Ethiopian coffee ceremony, a culturally established forum for community discussion, and designed to assist participants to build skills for healthy, non-violent, equitable relationships.Primary and secondary outcome measuresThis paper reports on the unit cost and cost-effectiveness of the interventions implemented. Cost-effectiveness is measured as the cost per case of past-year physical and/or sexual IPV averted.ResultsThe estimated annualised cost of developing and implementing UBL was 2015 US$296 772, or approximately 2015 US$74 per individual directly participating in the intervention and 2015 US$5 per person annually for each community-level beneficiary (woman of reproductive age in intervention communities). The estimated cost per case of past-year physical and/or sexual IPV averted was 2015 US$2726 for the sample of direct beneficiaries, and 2015 US$194 for the sample of all community-level beneficiaries.ConclusionsUBL is an effective and cost-effective intervention for the prevention of IPV in a low and middle-income country setting. Further research should explore strategies to quantify the positive effects of the intervention across other domains.Trial registration numberNCT02311699 (ClinicalTrials.gov); AEARCTR-0000211 (AEA Registry)

scholarly journals Training to enhance psychiatrist communication with patients with psychosis (TEMPO): cluster randomised controlled trial

2016 ◽  
Vol 209 (6) ◽  
pp. 517-524 ◽  
Author(s):  
Rose McCabe ◽  
Paula John ◽  
Jemima Dooley ◽  
Patrick Healey ◽  
Annie Cushing ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Therapeutic Relationship ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Medium Effect ◽  
Secondary Outcome ◽  
Shared Understanding ◽  
Cluster Randomised ◽  
Self Repair ◽  
Randomised Controlled

BackgroundA better therapeutic relationship predicts better outcomes. However, there is no trial-based evidence on how to improve therapeutic relationships in psychosis.AimsTo test the effectiveness of communication training for psychiatrists on improving shared understanding and the therapeutic relationship (trial registration: ISRCTN94846422).MethodIn a cluster randomised controlled trial in the UK, 21 psychiatrists were randomised. Ninety-seven (51% of those approached) out-patients with schizophrenia/schizoaffective disorder were recruited, and 64 (66% of the sample recruited at baseline) were followed up after 5 months. The intervention group received four group and one individualised session. The primary outcome, rated blind, was psychiatrist effort in establishing shared understanding (self-repair). Secondary outcome was the therapeutic relationship.ResultsPsychiatrists receiving the intervention used 44% more self-repair than the control group (adjusted difference in means 6.4, 95% CI 1.46–11.33, P<0.011, a large effect) adjusting for baseline self-repair. Psychiatrists rated the therapeutic relationship more positively (adjusted difference in means 0.20, 95% CI 0.03–0.37, P = 0.022, a medium effect), as did patients (adjusted difference in means 0.21, 95% CI 0.01–0.41, P = 0.043, a medium effect).ConclusionsShared understanding can be successfully targeted in training and improves relationships in treating psychosis.

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