scholarly journals Cross-sectoral rehabilitation intervention for patients with intermittent claudication versus usual care for patients in non-operative management - the CIPIC Rehab Study: study protocol for a randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Maj Siercke ◽  
Lise Pyndt Jørgensen ◽  
Malene Missel ◽  
Lau Caspar Thygesen ◽  
Pernille Peppercorn Blach ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Intermittent Claudication ◽  
Study Protocol ◽  
Controlled Trial ◽  
Operative Management ◽  
Rehabilitation Intervention ◽  
Randomised Controlled ◽  
Non Operative Management

scholarly journals Alexander Technique Lessons, Acupuncture Sessions or usual care for patients with chronic neck pain (ATLAS): study protocol for a randomised controlled trial

Trials ◽  
2013 ◽  
Vol 14 (1) ◽  
pp. 209 ◽  
Author(s):  
Hugh MacPherson ◽  
Helen E Tilbrook ◽  
Stewart J Richmond ◽  
Karl Atkin ◽  
Kathleen Ballard ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Neck Pain ◽  
Usual Care ◽  
Study Protocol ◽  
Controlled Trial ◽  
Chronic Neck Pain ◽  
Alexander Technique ◽  
Randomised Controlled

scholarly journals Motivating Structured walking Activity in people with Intermittent Claudication (MOSAIC): protocol for a randomised controlled trial of a physiotherapist-led, behavioural change intervention versus usual care in adults with intermittent claudication

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e030002 ◽  
Author(s):  
Lindsay Bearne ◽  
Melissa Galea Holmes ◽  
Julie Bieles ◽  
Saskia Eddy ◽  
Graham Fisher ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Intermittent Claudication ◽  
Controlled Trial ◽  
Behavioural Change ◽  
Walking Distance ◽  
Walking Ability ◽  
Walking Activity ◽  
Walking Exercise ◽  
Randomised Controlled

IntroductionWalking exercise is a recommended but underused treatment for intermittent claudication caused by peripheral arterial disease (PAD). Addressing the factors that influence walking exercise may increase patient uptake of and adherence to recommended walking. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of a physiotherapist-led behavioural change intervention on walking ability in adults with intermittent claudication (MOtivating Structured walking Activity in people with Intermittent Claudication (MOSAIC)) in comparison with usual care.Methods and analysisThe MOSAIC trial is a two-arm, parallel-group, single-blind RCT. 192 adults will be recruited from six National Health Service Hospital Trusts. Inclusion criteria are: aged ≥50 years, PAD (Ankle Brachial Pressure Index ≤0.90, radiographic evidence or clinician report) and intermittent claudication (San Diego Claudication Questionnaire), being able and willing to participate and provide informed consent. The primary outcome is walking ability (6 min walking distance) at 3 months. Outcomes will be obtained at baseline, 3 and 6 months by an assessor blind to group allocation. Participants will be individually randomised (n=96/group, stratified by centre) to receive either MOSAIC or usual care by an independent randomisation service. Estimates of treatment effects will use an intention-to-treat framework implemented using multiple regression adjusted for baseline values and centre.Ethics and disseminationThis trial has full ethical approval (London—Bloomsbury Research Ethics Committee (17/LO/0568)). It will be disseminated via patient forums, peer-reviewed publications and conference presentations.Trial registration numberISRCTN14501418

scholarly journals A feasibility, randomised controlled trial of a complex breathlessness intervention in idiopathic pulmonary fibrosis (BREEZE-IPF): study protocol

2019 ◽  
Vol 5 (4) ◽  
pp. 00186-2019 ◽  
Author(s):  
Caroline Wright ◽  
Simon P. Hart ◽  
Victoria Allgar ◽  
Anne English ◽  
Flavia Swan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Usual Care ◽  
Study Protocol ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Randomised Controlled

IntroductionIdiopathic pulmonary fibrosis (IPF) is a chronic and progressive lung disease that causes breathlessness and cough that worsen over time, limiting daily activities and negatively impacting quality of life. Although treatments are now available that slow the rate of lung function decline, trials of these treatments have failed to show improvement in symptoms or quality of life. There is an immediate unmet need for evidenced-based interventions that improve patients' symptom burden and make a difference to everyday living. This study aims to assess the feasibility of conducting a definitive randomised controlled trial of a holistic, complex breathlessness intervention in people with IPF.Methods and analysisThe trial is a two-centre, randomised controlled feasibility trial of a complex breathlessness intervention compared with usual care in patients with IPF. 50 participants will be recruited from secondary care IPF clinics and randomised 1:1 to either start the intervention within 1 week of randomisation (fast-track group) or to receive usual care for 8 weeks before receiving the intervention (wait-list group). Participants will remain in the study for a total of 16 weeks. Outcome measures will be feasibility outcomes, including recruitment, retention, acceptability and fidelity of the intervention. Clinical outcomes will be measured to inform outcome selection and sample size calculation for a definitive trial.Ethics and disseminationYorkshire and The Humber – Bradford Leeds Research Ethics Committee approved the study protocol (REC 18/YH/0147). Results of the main trial and all secondary end-points will be submitted for publication in a peer-reviewed journal.

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