Suchergebnisse

Background: The primary aim of this study is to evaluate the effectiveness of different doses (intensity) of supervised exercise training — concomitant with lifestyle counselling — as a primary care intervention tool for the management of metabolic syndrome risk factors in low-active adults with one or more such factors (programme name in Catalan: Bellugat de CAP a peus). Methods/Design: Three-arm, randomized controlled clinical trial implemented in the primary care setting, with a duration of 40 weeks (16 weeks intervention and 24-week follow-up). Adults aged 30 to 55 years with metabolic risk factors will be randomized into three intervention groups: 1) aerobic interval training (16 supervised training lessons) plus a healthy lifestyle counselling programme (6 group and 3 individual meetings); 2) low-to-moderate intensity continuous training (16 supervised training lessons) plus the same counselling programme; or 3) the counselling- programme without any supervised physical exercise. The main output variables assessed will be risk factors for metabolic syndrome (waist circumference, blood pressure, and levels of plasma triglycerides, high-density lipoproteins and glucose), systemic inflammation, cardiorespiratory fitness, physical activity and sedentary behaviour, dietary habits, health-related quality of life, self-efficacy and empowerment. Economic factors will also be analysed in order to determine the cost-effectiveness of the programme. These variables will be assessed three times during the study: at baseline, at the end of the intervention, and at followup. We estimate to recruit 35 participants per group. Discussion: The results of this study will provide insight into the immediate and medium-term effects on metabolic risk and lifestyle of a combined approach involving aerobic interval training and a multidisciplinary behavioural intervention. If effective, the proposed intervention would provide both researchers and practitioners in this field with a platform on which to develop similar intervention programmes for tackling the repercussions of an unhealthy lifestyle. Trial registration: Clinical trials.gov. NTC02832453. Registered 6 July 2016 (retrospectively registered). ; The study has been peer-reviewed (blinded) and quoted (6.4/7) by the AGAUR (Agency for Management of University and Research Grants) of the government of Catalonia (Generalitat de Catalonia). GE has been granted for hers' participation to the study as a PhD student. (Ref: 2014-PINEF-00003. PRE/2448/2014, de 30 October, DOGC num 6743–5.11.2014). This funding source had no role in the design of this study and will not have any role during its execution, analyses or interpretation of the data. The study is mainly supported by the National Institute of Physical Education (INEFC)-Centre de Lleida. The funding covers central organisation, design, management, assessments, and analysis and reporting of the study. INEFC has also provided funding's to support the printing of educational resources (Funding's to research-2015) and partially blood analysis reagents (Funding's to research-2016). The Catalonian Health Institute (ICS) provides the setting for the counselling sessions and supports recruitment, phlebotomy and general blood analysis. Ekke's sport centre (local sport centre) provides the setting and the necessary equipment for the physical exercise sessions. The department of Experimental Medicine of the University of Lleida supports blood specimens' storage and metabolomics/lipidomics and miRNA blood analysis. The Primary Care Research Institute (IDIAP) Jordi Gol provides support for the randomization and statistical analysis of data. The Development of Healthy Organizations and Territories (DOTS) group of the University of LLeida and the Diputació de Lleida provided funding's to support partially miRNA blood analysis and the execution of physical activity sessions (Funding to research 25-07-2016).