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首页> 外文期刊>Trials >The impact of lifestyle Physical Activity Counselling in IN-PATients with major depressive disorders on physical activity, cardiorespiratory fitness, depression, and cardiovascular health risk markers: study protocol for a randomized controlled trial
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The impact of lifestyle Physical Activity Counselling in IN-PATients with major depressive disorders on physical activity, cardiorespiratory fitness, depression, and cardiovascular health risk markers: study protocol for a randomized controlled trial

机译：体育抑郁症患者体育活动咨询对体育症，心肺健身，抑郁症和心血管健康风险标志的影响：随机对照试验的研究方案

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Major depressive disorder (MDD) is a widespread and burdensome psychiatric issue. Physical activity counselling may increase lifestyle physical activity and cardiorespiratory fitness in this specific and particularly vulnerable population, which often suffers from both mental and physical health problems. Therefore, this study will examine the impact of a lifestyle physical activity counselling intervention on physical activity, cardiorespiratory fitness, depression, and cardiovascular health risk markers among in-patients diagnosed with MDD compared to controls. Secondary purposes are to examine the acceptability and perceived usefulness of the intervention among these patients, to find out whether the effectiveness of the intervention is moderated by genetic factors, and to compare baseline values with an age- and gender-matched group of healthy controls. The study is designed as a multi-centric two-arm randomized clinical trial including an intervention group and a placebo control group, allocation concealment, single-blinding, and intention-to-treat analysis. Participants (N?=?334) will be continuously recruited from four clinics specialized in the treatment of MDD. The intervention builds on a standardized, theory-based, low-cost lifestyle physical activity counselling programme, which was specifically designed for an in-patient rehabilitation setting. The placebo control condition consists of general instructions about health-enhancing physical activity. Data assessments will take place 2-3?weeks after admission to in-patient treatment (baseline), and 6 weeks (post) and 12?months (follow-up) after discharge from in-patient treatment. The primary outcome is objectively assessed physical activity at follow-up. Because regular physical activity has proven to be an important predictor of long-term response and remission in patients with major depression, we believe that our planned study may lay important groundwork by showing how individually tailored lifestyle physical activity counselling can be integrated into given clinical structures. Improving physical activity may have important implications for tackling metabolic and cardiovascular disease and increasing mood and cognitive functioning in this at-risk population, hence limiting the future burden of multiple chronic conditions. Increased physical activity may also reduce the likelihood of future depressive episodes. By moving towards the primary prevention of chronic physical conditions, much can be done to enhance the quality and quantity of life of people with MDD. ISRCTN, ISRCTN10469580 . Registered on 3 September 2018.
机译：主要抑郁症（MDD）是一种普遍和繁琐的精神病问题。体育活动咨询可能会增加这种特定且特别脆弱的人群中的生活方式身体活动和心肺刺激性，这往往患有心理和身体健康问题。因此，本研究将研究生活方式身体活动咨询干预对患有MDD的患者患者的身体活动，心肺健身，抑郁症和心血管健康风险标记的影响。次要目的是检查这些患者中干预的可接受性和感知的有用性，以了解干预的有效性是否受到遗传因素的缓和，并将基线值与年龄和性别匹配的健康对照组进行比较。该研究设计为多合一体的双臂随机临床试验，包括干预组和安慰剂对照组，分配隐藏，单致盲和意图治疗分析。将参与者（N？=？334）从专门用于治疗MDD的四个诊所持续招募。干预措施以标准化，理论为基础的低成本生活方式的体育咨询计划建立在标准化，理论的低成本生活方式的身体活动咨询计划中，专为患有患者的康复环境而设计。安慰剂控制条件包括有关健康增强体力活动的一般指示。数据评估将在入院治疗（基线）和6周（柱）和12个月（后续）免受患有病人治疗后进行数据评估。主要结果是客观评估随访时的身体活动。由于经常的身体活动已被证明是主要抑郁症患者长期反应和缓解的重要预测因子，我们认为我们的计划研究可以通过展示单独量身定制的生活方式咨询如何整合到给定的临床结构中来奠定重要的基础。 。改善的身体活动可能对解决代谢和心血管疾病的重要意义，并且在这种环境中增加心情和认知功能，因此限制了多种慢性病的未来负担。增加的身体活动也可能降低未来抑郁发作的可能性。通过朝着慢性身体状况的初步预防，可以提高MDD人们的生活质量和数量。 ISRCTN，ISRCTN10469580。 2018年9月3日注册。

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