Maturitas
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Randomized Controlled Trial
Pilot study of a preventive multicomponent nurse intervention to reduce the incidence and severity of delirium in hospitalized older adults: MID-Nurse-P.
Although multicomponent interventions are the gold standard for delirium management, few nurse-led interventions in Acute Geriatric Units (AGU) are described. ⋯ The MID-Nurse Study is feasible, and a multicomponent nurse-led intervention on patients with delirium in an AGU can reduce delirium prevalence, incidence, and severity. The clinical trial registration number ClinicalTrials.gov ID: NCT02558777.
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Randomized Controlled Trial
Effects of a six-week Pilates intervention on balance and fear of falling in women aged over 65 with chronic low-back pain: A randomized controlled trial.
The purpose of our study was to evaluate the effects of six weeks of Pilates regarding functional balance, fear of falling and pain in community living women older than 65 years old with chronic low-back pain. ⋯ Six weeks of Pilates exercises may be effective in fall prevention through the improvement of FoF, functional balance, and pain in Spanish women over 65 years old with CLBP.
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Randomized Controlled Trial Pragmatic Clinical Trial
Pelvic floor muscle training versus watchful waiting or pessary treatment for pelvic organ prolapse (POPPS): design and participant baseline characteristics of two parallel pragmatic randomized controlled trials in primary care.
Pelvic floor muscle training (PFMT) and pessaries are commonly used in the conservative treatment of pelvic organ prolapse (POP). Because there is a lack of evidence regarding the optimal choice between these two interventions, we designed the "Pelvic Organ prolapse in primary care: effects of Pelvic floor muscle training and Pessary treatment Study" (POPPS). POPPS consists of two parallel open label randomized controlled trials performed in primary care, in women aged ≥55 years, recruited through a postal questionnaire. ⋯ Cost-effectiveness will be calculated based on societal costs, using the PFDI-20 and the EQ-5D as outcomes. In this paper the POPPS design, the encountered challenges and our solutions, and participant baseline characteristics are presented. For both trials the target numbers of patients in each treatment group are achieved, giving this study sufficient power to lead to promising results.
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Randomized Controlled Trial Comparative Study
Efficacy and safety of high dose intramuscular or oral cholecalciferol in vitamin D deficient/insufficient elderly.
To evaluate and compare the effects and safety of high dose intramuscular (IM) or oral cholecalciferol on 25-hydroxyvitamin D [25(OH)D] levels, muscle strength and physical performance in vitamin D deficient/insufficient elderly. ⋯ In vitamin D deficient/insufficient elderly, a single megadose of cholecalciferol increased vitamin D levels significantly and the majority of the patients reached optimal levels. Although both administration routes are effective and appear to be safe, IM application is more effective in increasing 25(OH)D levels and balance performance.
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Randomized Controlled Trial Multicenter Study
Effects of tibolone on climacteric symptoms and quality of life in breast cancer patients--data from LIBERATE trial.
Climacteric symptoms such as hot flushes and vaginal dryness are very common in breast cancer patients, resulting either from age or adjuvant therapy. Tibolone, a synthetic steroid, is effective in reducing these symptoms in healthy post-menopausal women, but this has never been studied in a large breast cancer population. ⋯ The results of the LIBERATE trial show that tibolone is effective in symptomatic breast cancer patients and improves their quality of life. However, this finding should be judged within the context of the main outcome of the trial, showing that tibolone increases the risk of recurrence. The use of tibolone in women with breast cancer will remain contraindicated and any off-label use incurs a now proven risk.