Older Person's Exercise and Nutrition Study (OPEN): a Simple Physical Exercise Combined With Protein Supplement - Effects on Functional Status and Independence Among Older People: A Cluster Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The primary outcome measure for functional status will be the number of sit-to-stands that the participant is able to complete in 30 seconds
研究概览
简要总结
The novelty with the OPEN study is to evaluate the effects of the simple sit-to-stand exercise during routine care, in combination with an oral protein-rich supplement, on functional status and independence in frail older persons. In this study we will also explore the experiences among older persons in the intervention group as wells as among staff of promoting the sit-to-stand exercise and nutritional supplement to gain knowledge for implementation as a daily routine in nursing homes across Sweden.
Hypothesis The main hypothesis of the OPEN study is that physical exercise performed as a daily routine along with an oral protein-rich supplement, will result in improved functional status and independence in everyday life activities and thereby enhance health-related quality of life in older persons living in nursing homes. The primary outcome measure for functional status will be the number of sit-to-stands that the participant is able to complete in 30 seconds.
Specific aims Aim I: To study the effects of the sit-to-stand exercise combined with an oral protein-rich supplement on functional and nutritional status, and health-related quality of life, and the frequency and incidence of falls, pressure ulcers and incontinence in older persons living in nursing homes. Furthermore, the cost effectiveness of the combination of the sit to stand exercise and oral protein-rich supplement vs. the control group will also be examined.
Aim II: To describe the older persons' perceptions of daily being offered to conduct the sit-to-stand exercise and to drink the nutritional supplement.
Aim III: To describe staff's perceptions of supporting the sit-to-stand exercise and the nutritional supplement with older persons living in nursing homes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to rise independently from a seated position to standing-
排除标准
- •severe dysphagia,
- •tube feeding,
- •severe kidney failure,
- •bedridden people,
- •terminal stage of life
- •Lack of informed consent.
研究组 & 干预措施
Intervention
The participants will be supported to perform the sit-to-stand exercise at least four times per day during 12 weeks (7 days/week).
The participants will also be offered an oral protein-rich supplement (125 ml, 18 g protein (24% of RDI), 300 kcal) twice a day in conjunction with two of the four sit-to-stand exercises during 12 weeks (7 days/week).
干预措施: oral protein-rich supplement (Dietary Supplement)
Intervention
The participants will be supported to perform the sit-to-stand exercise at least four times per day during 12 weeks (7 days/week).
The participants will also be offered an oral protein-rich supplement (125 ml, 18 g protein (24% of RDI), 300 kcal) twice a day in conjunction with two of the four sit-to-stand exercises during 12 weeks (7 days/week).
干预措施: Exercise (Other)
Control
Standard care
结局指标
主要结局
The primary outcome measure for functional status will be the number of sit-to-stands that the participant is able to complete in 30 seconds
时间窗: 12 weeks
次要结局
- Blood Chemistry - transthyretin(12 weeks)
- Quality of Life(12 weeks)
- Healthcare Resource Use - hospitalisations(12 weeks)
- Medical incidences - incontinence(12 weeks)
- Healthcare Resource Use - time of staff(12 weeks)
- Everyday activities and function(12 weeks)
- Blood Chemistry - IGF-1(12 weeks)
- Walking ability(12 weeks)
- Nutritional status(12 weeks)
- Blood Chemistry - albumin(12 weeks)
- Blood Chemistry - Cystatin C(12 weeks)
- Functional balance(12 weeks)
- Body composition(12 weeks)
- Blood Chemistry - S-25 vit D(12 weeks)
- Blood Chemistry - creatinin(12 weeks)
- Healthcare Resource Use - number of visits(12 weeks)
- Healthcare Resource Use - length of stay(12 weeks)
- Medical incidences - fall(12 weeks)
- Medical incidences - pressure ulcers(12 weeks)
- Medical incidences - infections(12 weeks)
- Blood Chemistry - CRP(12 weeks)
研究者
Anne-Marie Bostrom
Associate Professor, Senior Lecturer
Karolinska Institutet