A study protocol of Older Person's Exercise and Nutrition Study (OPEN) - a sit-to-stand activity combined with oral protein supplement - effects on physical function and independence: a cluster randomized clinical trial.
A study protocol of Older Person's Exercise and Nutrition Study (OPEN) - a sit-to-stand activity combined with oral protein supplement - effects on physical function and independence: a cluster randomized clinical trial.
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DOI：
10.1186/s12877-018-0824-1
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发表时间：
2018-06-07
期刊：
影响因子：
4.1
通讯作者：
Boström AM
中科院分区：
文献类型：
--
作者：
Grönstedt H;Vikström S;Cederholm T;Franzén E;Seiger Å;Wimo A;Faxén-Irving G;Boström AM
营养不良和年龄增加会增加肌肉减少症的发展，即肌肉质量和力量的损失，这会增加日常生活活动（ADL）受损和独立性降低的风险。蛋白质缺乏在肌肉减少症的发展中起重要作用。为了增加肌肉质量，蛋白质的摄入应与体育锻炼相结合。一种日常的身体活动，从坐到站的运动，已被证明可以减少老年人对ADL的依赖。我们的研究旨在评估坐立运动与富含蛋白质的营养补充剂相结合对体弱养老院居民身体功能和独立性的影响。住院医师的看法和经验的干预和工作人员的经验，支持居民完成干预也将进行探讨。这项研究是一项双臂随机对照试验，将在瑞典两个城市的养老院进行。我们将招募120名75岁或以上的住院医生，他们能够从坐姿站起来。随机分配到干预组的居民（n = 60）将每天进行四次坐立运动，并将提供富含蛋白质的口服补充剂，每天两次。干预期将持续12周，将在基线和12周随访时测量身体功能、营养状况、生活质量和健康经济。主要结局将是30秒内执行的椅子起身次数。对照组将接受标准护理。将通过意向治疗分析和混合效应模型分析数据。在干预期的最后一部分，将举行与居民的个别访谈，主题是开放概念的可行性。同样，将与工作人员进行焦点小组访谈。居民的身心健康有望得到改善。甚至工作人员的工作情况也可能受到积极影响。OPEN研究的一个创新特点是简单的干预，包括一个基本的日常活动，可以由几个养老院居民在现有工作人员和可用资源的支持下进行。ClinicalTrials.gov标识符：NCT 02702037。
Poor nutrition and age per see add to the development of sarcopenia, i.e. loss of muscle mass and strength, which contributes to increased risk of impaired activities of daily living (ADL) and reduced independence. Protein deficiency plays an important role in the development of sarcopenia. In order to increase the muscle mass protein intake should be combined with physical exercise. A daily physical activity, the sit-to-stand exercise, has been proven to decrease older persons’ dependence in ADL. Our study aims to evaluate the effects of the sit-to-stand exercise in combination with a protein-rich nutritional supplement, on physical function and independence in frail nursing home residents. The resident’s perceptions and experiences of the intervention and the staff’s experiences of supporting the resident to complete the intervention will also be explored. The study is a two-arm cluster-randomized controlled trial which will be performed in nursing homes at two municipalities in Sweden. We will recruit 120 residents, age 75 or older and able to stand up from a seated position. Residents (n = 60) randomized to the intervention group will perform the sit-to-stand exercise at four occasions daily and will be offered a protein-rich oral supplement, twice a day. The intervention period will last for 12 weeks and measures of physical function, nutritional status, quality of life and health economy will be performed at baseline and at 12-weeks follow-up. The primary outcome will be the number of chair rises performed in 30 s. The control group will receive standard care. Data will be analysed by intention-to-treat analysis and with mixed effect models. During the last part of the intervention period individual interviews with the residents, on the topic of feasibility with the OPEN concept will be held. Likewise, focus-group-interviews with staff will be performed. The residents’ physical and mental health could be expected to improve. Even the work situation for staff could be positively affected. One innovative feature of the OPEN study is the simple intervention consisting of a basic daily activity that can be performed by several nursing home residents with the support of existing staff and available resources. ClinicalTrials.gov Identifier: NCT02702037.
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3.4
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