Pulmonary rehabilitation integrated coached exercise training for patients with COPD: a study protocol for a randomized controlled trial
This study provides a simple, feasible, repeatable, and fun exercise training approach. To the best of our knowledge, there are no randomized controlled trials in the existing literature on PR-integrated coached exercise. The protocol shared in our study can be used as a reference for exercise training in patients with COPD.Trial registrationEthical approval (BF2020-236 –02) was obtained from the Guangdong Provincial Hospital of Chinese Medicine Human Research Ethics Committee. All participants signed an informed consent form. ChiCTR-2100043543. The registration date is 2021/02/21 and it is the third version. (Source: Trials)
Source: Trials - January 30, 2023 Category: Research Source Type: clinical trials
The effect of COVID rehabilitation for ongoing symptoms Post HOSPitalisation with COVID-19 (PHOSP-R): protocol for a randomised parallel group controlled trial on behalf of the PHOSP consortium
AbstractIntroductionMany adults hospitalised with COVID-19 have persistent symptoms such as fatigue, breathlessness and brain fog that limit day-to-day activities. These symptoms can last over 2 years. Whilst there is limited controlled studies on interventions that can support those with ongoing symptoms, there has been some promise in rehabilitation interventions in improving function and symptoms either using face-to-face or digital methods, but evidence remains limited and these studi es often lack a control group.Methods and analysisThis is a nested single-blind, parallel group, randomised control trial with embedde...
Source: Trials - January 26, 2023 Category: Research Source Type: clinical trials
Implementation challenges and lessons learned from the STREAM clinical trial —a survey of trial sites
ConclusionsExisting practices for clinical trial implementation should be reevaluated. Sponsors should consider the local context and the need to increase upfront investment in the cross-cutting thematic areas identified to improve trial implementation. (Source: Trials)
Source: Trials - January 23, 2023 Category: Research Source Type: clinical trials
Update to the study protocol Face Your Fears: Virtual reality-based cognitive behavioral therapy (VR-CBT) versus standard CBT for paranoid ideations in patients with schizophrenia spectrum disorders: a randomized clinical trial
AbstractWe unfortunately need to make an update to our published study protocol that describes a significant change in the design of the study. The Committee on Health Research Ethics of the Capital Region Denmark recently rejected the approval of changing the primary outcome in the trial, on the invariable grounds that the trial has already commenced. It is therefore necessary to retain the Green Paranoid Thought Scale (GPTS) part B, ideas of persecution, as our primary outcome, and GPTS part A, ideas of social reference, as a secondary outcome, which is described opposite in our published study protocol. The exchange of ...
Source: Trials - January 23, 2023 Category: Research Source Type: clinical trials
Enhancement of the haemostatic effect of platelets in the presence of high normal concentrations of von Willebrand factor for critically ill patients needing platelet transfusion —a protocol for the will-plate randomised controlled trial
This study has been approved by the Ethics Committee of Northwestern and Central Switzerland and will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the ICH-GCP or ISO EN 14155 (as far as applicable) and all national legal and regulatory requirements. The study results will be presented at international conferences and published in a peer-reviewed journal.Trials registrationClinicalTrials.gov NCT04555785. Protocol version: Clinical Study Protocol Version 2, 01.11.2020. Registered on Sept. 21, 2020. (Source: Trials)
Source: Trials - January 20, 2023 Category: Research Source Type: clinical trials
Efficacy of self-management program associated with a spa therapy for knee osteoarthritis patients (GETT 2): a research protocol for a randomized trial
AbstractIntroductionOsteoarthritis is a chronic pathology that involves multidisciplinary management. Self-management for patients is an essential element, present in all international guidelines. During the time of the spa therapy, the patient is receptive to take the advantage of self-management workshops.The aim of this study is to assess the effects of 18 days spa therapy associated with a self-management intervention in patients with knee osteoarthritis in comparison with spa therapy alone on a priority objective, personalized and determined with the patient, chosen in the list of 5 objectives determined during the se...
Source: Trials - January 19, 2023 Category: Research Source Type: clinical trials
Effect of high-frequency repetitive transcranial magnetic stimulation under different intensities upon rehabilitation of chronic pelvic pain syndrome: protocol for a randomized controlled trial
This study is approved by the Ethics Committee of Bao ’an People’s Hospital, Shenzhen, Guangdong Province (approval number: BYL20211203). The results will be submitted for publication in peer-reviewed journals and disseminated at scientific conferences (Protocol version 1.0-20220709).Trial registrationChictr.org.cn, ID: ChiCTR2200055615. Registered on 14 January 2022,http://www.chictr.org.cn/showproj.aspx?proj=146720. Protocol version 1.0-20220709. (Source: Trials)
Source: Trials - January 19, 2023 Category: Research Source Type: clinical trials
Phlebotomy resulting in controlled hypovolemia to prevent blood loss in major hepatic resections (PRICE-2): study protocol for a phase 3 randomized controlled trial
This study is a double-blind multicenter randomized controlled trial. Adult patients undergoing major hepatic resections for any indication will be randomly allocated in a 1:1 ratio to either hypovolemic phlebotomy and usual care or usual care alone. Exclusion criteria will be minor resections, preoperative hemoglobin<100g/L, renal insufficiency, and other contraindication to hypovolemic phlebotomy. The primary outcome will be the proportion of patients receiving at least one allogeneic RBC transfusion unit within 30 days of the onset of surgery. Secondary outcomes will include transfusion of other allogeneic blood prod...
Source: Trials - January 18, 2023 Category: Research Source Type: clinical trials
