BACKGROUND: Many strategies are in use with the intention of preventing or minimizing delayed onset muscle soreness and fatigue after exercise. Cold-water immersion, in water temperatures of less than 15 °C, is currently one of the most popular interventional strategies used after exercise. OBJECTIVES: To determine the effects of cold-water immersion in the management of muscle soreness after exercise. SEARCH METHODS: In February 2010, we searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (The Cochrane Library (2010, Issue 1), Medline, Embase, Cumulative Index to Nursing and Allied Health (CINAHL), British Nursing Index and archive (BNI), and the Physiotherapy Evidence Database (PEDro). We also searched the reference lists of articles, handsearched journals and conference proceedings and contacted experts. In November 2011, we updated the searches of Central (2011, Issue 4), Medline (up to November Week 3 2011), Embase (to 2011 Week 46) and CINAHL (to 28 November 2011) to check for more recent publications. SELECTION CRITERIA: Randomized and quasi-randomized trials comparing the effect of using cold-water immersion after exercise with: passive intervention (rest/no intervention), contrast immersion, warmwater immersion, active recovery, compression, or a different duration/ dosage of cold-water immersion. Primary outcomes were pain (muscle soreness) or tenderness (pain on palpation), and subjective recovery (return to previous activities without signs or symptoms). DATA COLLECTION AND ANALYSIS: Three authors independently evaluated study quality and extracted data. Some of the data were obtained following author correspondence or extracted from graphs in the trial reports. Where possible, data were pooled using the fixed-effect model. MAIN RESULTS: Seventeen small trials were included, involving a total of 366 participants. Study quality was low. The temperature, duration and frequency of cold-water immersion varied between the different trials as did the exercises and settings. The majority of studies failed to report active surveillance of pre-defined adverse events. Fourteen studies compared cold-water immersion with passive intervention. Pooled results for muscle soreness showed statistically significant effects in favour of cold-water immersion after exercise at 24 hour (standardized mean difference, SMD-0.55, 95% CI-0.84 to-0.27; 10 trials), 48 hour (SMD-0.66, 95% CI-0.97 to-0.35; 8 trials), 72 hour (SMD-0.93; 95% CI-1.36 to-0.51; 4 trials) and 96 hour (SMD-0.58; 95% CI-1.00 to-0.16; 5 trials) follow-ups. These results were heterogeneous. Exploratory subgroup analyses showed that studies using cross-over designs or running-based exercises showed significantly larger effects in favour of coldwater immersion. Pooled results from two studies found cold-water immersion groups had significantly lower ratings of fatigue (MD-1.70; 95% CI-2.49 to-0.90; 10 units scale, best to worst), and potentially improved ratings of physical recovery...

BACKGROUND: Many strategies are in use with the intention of preventing or minimizing delayed onset muscle soreness and fatigue after exercise. Cold-water immersion, in water temperatures of less than 15 °C, is currently one of the most popular interventional strategies used after exercise. OBJECTIVES: To determine the effects of cold-water immersion in the management of muscle soreness after exercise. SEARCH METHODS: In February 2010, we searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (The Cochrane Library (2010, Issue 1), Medline, Embase, Cumulative Index to Nursing and Allied Health (CINAHL), British Nursing Index and archive (BNI), and the Physiotherapy Evidence Database (PEDro). We also searched the reference lists of articles, handsearched journals and conference proceedings and contacted experts. In November 2011, we updated the searches of Central (2011, Issue 4), Medline (up to November Week 3 2011), Embase (to 2011 Week 46) and CINAHL (to 28 November 2011) to check for more recent publications. SELECTION CRITERIA: Randomized and quasi-randomized trials comparing the effect of using cold-water immersion after exercise with: passive intervention (rest/no intervention), contrast immersion, warmwater immersion, active recovery, compression, or a different duration/ dosage of cold-water immersion. Primary outcomes were pain (muscle soreness) or tenderness (pain on palpation), and subjective recovery (return to previous activities without signs or symptoms). DATA COLLECTION AND ANALYSIS: Three authors independently evaluated study quality and extracted data. Some of the data were obtained following author correspondence or extracted from graphs in the trial reports. Where possible, data were pooled using the fixed-effect model. MAIN RESULTS: Seventeen small trials were included, involving a total of 366 participants. Study quality was low. The temperature, duration and frequency of cold-water immersion varied between the different trials as did the exercises and settings. The majority of studies failed to report active surveillance of pre-defined adverse events. Fourteen studies compared cold-water immersion with passive intervention. Pooled results for muscle soreness showed statistically significant effects in favour of cold-water immersion after exercise at 24 hour (standardized mean difference, SMD-0.55, 95% CI-0.84 to-0.27; 10 trials), 48 hour (SMD-0.66, 95% CI-0.97 to-0.35; 8 trials), 72 hour (SMD-0.93; 95% CI-1.36 to-0.51; 4 trials) and 96 hour (SMD-0.58; 95% CI-1.00 to-0.16; 5 trials) follow-ups. These results were heterogeneous. Exploratory subgroup analyses showed that studies using cross-over designs or running-based exercises showed significantly larger effects in favour of coldwater immersion. Pooled results from two studies found cold-water immersion groups had significantly lower ratings of fatigue (MD-1.70; 95% CI-2.49 to-0.90; 10 units scale, best to worst), and potentially improved ratings of physical recovery...

NCT01463579. (results), https://clinicaltrials.gov/.

No abstract

BackgroundEvidence about the effectiveness of music therapy for improving the quality of life of palliative care patients is positive but weak in terms of risk of bias.MethodsThis study aimed to determine the feasibility of a randomised controlled trial to evaluate the effectiveness of music therapy for improving the quality of life of hospice inpatients, as measured by the McGill Quality of Life questionnaire. Objectives included recruitment of 52 participants over 12 months and provision of data to support the calculation of the required sample size for a definitive randomised trial, taking into account the retention rates of recruited participants; and evaluation of the viability of the intervention and the acceptability of the assessment tool. The design was a single-centre, researcher-blinded randomised pilot and feasibility study involving two parallel groups. Participants were recruited from one inpatient hospice unit in Northern Ireland. Eligibility criteria were an Eastern Cooperative Oncology Group performance status of two or lower and an Abbreviated Mental Test score of seven or more. Consenting patients were randomly allocated to the intervention or control group using a 1:1 allocation ratio. The intervention group received up to six individual music therapy sessions over 3 weeks in addition to usual care. The control group received usual care only.ResultsFifty one participants were recruited over 12 months. Twenty five were allocated to the intervention group and 26 to the control group. Seventy one percent of participants were lost to follow up by week 3, the proposed primary endpoint. The primary endpoint was moved from week 3, when 71% were lost to follow up to week 1, when 33% were lost. The McGill Quality of Life questionnaire was generally acceptable to participants. In order to detect a small to moderate effect size of 0.3, a fully powered study would require the recruitment of 698 participants.ConclusionsA Phase III randomised controlled trial to evaluate the effectiveness of music therapy in improving the quality of life of hospice inpatients is feasible.Trial registrationClinicalTrials.gov: NCT02791048. Registered 6 June 2016.

Background/aimsTo report the protocol of a trial designed to evaluate the efficacy, safety and mechanism of action of low-dose atropine (0.01%) eye-drops for reducing progression of myopia in UK children.MethodsMulticentre, double-masked, superiority, placebo-controlled, randomised trial. We will enrol children aged 6–12 years with myopia of −0.50 dioptres or worse in both eyes.We will recruit 289 participants with an allocation ratio of 2:1 (193 atropine; 96 placebo) from five centres. Participants will instil one drop in each eye every day for 2 years and attend a research centre every 6 months. The vehicle and preservative will be the same in both study arms.The primary outcome is SER of both eyes measured by autorefractor under cycloplegia at 2 years (adjusted for baseline). Secondary outcomes include axial length, best corrected distance visual acuity, near visual acuity, reading speed, pupil diameter, accommodation, adverse event rates and allergic reactions, quality of life (EQ-5D-Y) and tolerability at 2 years. Mechanistic evaluations will include: peripheral axial length, peripheral retinal defocus, anterior chamber depth, iris colour, height and weight, activities questionnaire, ciliary body biometry and chorioretinal thickness. Endpoints from both eyes will be pooled in combined analysis using generalised estimating equations to allow for the correlation between eyes within participant. Three years after cessation of treatment, we will also evaluate refractive error and adverse events.ConclusionsThe Childhood Atropine for Myopia Progression in the UK study will be the first randomised trial reporting outcomes of low-dose atropine eye-drops for children with myopia in a UK population.Trial registration numberISRCTN99883695, NCT03690089.

BackgroundIn the UK, macular laser is the treatment of choice for people with diabetic macular oedema with central retinal subfield thickness (CST) < 400 μm, as per National Institute for Health and Care Excellence guidelines. It remains unclear whether subthreshold micropulse laser is superior and should replace standard threshold laser for the treatment of eligible patients.MethodsDIAMONDS is a pragmatic, multicentre, allocation-concealed, randomised, equivalence, double-masked clinical trial that aims to determine the clinical effectiveness and cost-effectiveness of subthreshold micropulse laser compared with standard threshold laser, for the treatment of diabetic macular oedema with CST < 400 μm. The primary outcome is the mean change in best-corrected visual acuity in the study eye from baseline to month 24 post treatment. Secondary outcomes (at 24 months) include change in binocular best corrected visual acuity; CST; mean deviation of the Humphrey 10–2 visual field; change in percentage of people meeting driving standards; European Quality of Life-5 Dimensions, National Eye Institute Visual Functioning Questionnaire-25 and VisQoL scores; incremental cost per quality-adjusted life year gained; side effects; number of laser treatments and use of additional therapies.The primary statistical analysis will be per protocol rather than intention-to-treat analysis because the latter increases type I error in non-inferiority or equivalence trials. The difference between lasers for change in best-corrected visual acuity (using 95% CI) will be compared to the permitted maximum difference of five Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Linear and logistic regression models will be used to compare outcomes between treatment groups. A Markov-model-based cost-utility analysis will extend beyond the trial period to estimate longer-term cost-effectiveness.DiscussionThis trial will determine the clinical effectiveness and cost-effectiveness of subthreshold micropulse laser, when compared with standard threshold laser, for the treatment of diabetic macular oedema, the main cause of sight loss in people with diabetes mellitus.Trial registrationInternational Standard Randomised Controlled Trials, ISRCTN17742985. Registered on 19 May 2017 (retrospectively registered).Electronic supplementary materialThe online version of this article (10.1186/s13063-019-3199-5) contains supplementary material, which is available to authorized users.

Background The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI). Methods Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action. Discussion This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT. Trial registration ISRCTN, ISRCTN41009897. Registered 19 November 2019. ClinicalTrials.gov, NCT04181879. Registered 02 December 2019.