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Castel Guelfo di Bologna, Italy

Belvederi Murri M.,University of Genoa | Belvederi Murri M.,Kings College London | Amore M.,University of Genoa | Menchetti M.,University of Bologna | And 12 more authors.
British Journal of Psychiatry | Year: 2015

Background Interventions including physical exercise may help improve the outcomes of late-life major depression, but few studies are available. Aims To investigate whether augmenting sertraline therapy with physical exercise leads to better outcomes of late-life major depression. Method Primary care patients (465 years) with major depression were randomised to 24 weeks of higher-intensity, progressive aerobic exercise plus sertraline (S+PAE), lowerintensity, non-progressive exercise plus sertraline (S+NPE) and sertraline alone. The primary outcome was remission (a score of 410 on the Hamilton Rating Scale for Depression). Results A total of 121 patients were included. At study end, 45% of participants in the sertraline group, 73% of those in the S+NPE group and 81% of those in the S+PAE group achieved remission (P = 0.001). A shorter time to remission was observed in the S+PAE group than in the sertraline-only group. Conclusions Physical exercise may be a safe and effective augmentation to antidepressant therapy in late-life major depression. © The Royal College of Psychiatrists 2015.

Kho M.E.,McMaster University | Kho M.E.,Johns Hopkins University | Molloy A.J.,St. Josephs Healthcare | Clarke F.,McMaster University | And 13 more authors.
BMJ Open | Year: 2016

Introduction: Early exercise with in-bed cycling as part of an intensive care unit (ICU) rehabilitation programme has the potential to improve physical and functional outcomes following critical illness. The objective of this study is to determine the feasibility of enrolling adults in a multicentre pilot randomised clinical trial (RCT) of early in-bed cycling versus routine physiotherapy to inform a larger RCT. Methods and analysis: 60-patient parallel group pilot RCT in 7 Canadian medical-surgical ICUs. We will include all previously ambulatory adult patients within the first 0-4 days of mechanical ventilation, without exclusion criteria. After informed consent, patients will be randomised using a web-based, centralised electronic system, to 30 min of in-bed leg cycling in addition to routine physiotherapy, 5 days per week, for the duration of their ICU stay (28 days maximum) or routine physiotherapy alone. We will measure patients' muscle strength (Medical Research Council Sum Score, quadriceps force) and function (Physical Function in ICU Test (scored), 30 s sit-tostand, 2 min walk test) at ICU awakening, ICU discharge and hospital discharge. Our 4 feasibility outcomes are: (1) patient accrual of 1-2 patients per month per centre, (2) protocol violation rate <20%, (3) outcome measure ascertainment >80% at the 3 time points and (4) blinded outcomes ascertainment >80% at hospital discharge. Hospital outcome assessors are blinded to group assignment, whereas participants, ICU physiotherapists, ICU caregivers, research coordinators and ICU outcome assessors are not blinded to group assignment. We will analyse feasibility outcomes with descriptive statistics. Ethics and dissemination: Each participating centre will obtain local ethics approval, and results of the study will be published to inform the design and conduct of a future multicentre RCT of in-bed cycling to improve physical outcomes in ICU survivors.

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