Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Changes in activities of daily living (ADL) function, by Barthel index-100
研究概览
简要总结
Aproximately a third of persons older than 70 years lose physical function and ability to take care of themselves during a stay at a hospital. This is associated to an increased risk of readmission and mortality. Earlier research has shown that insufficient nutrition and physical activity during hospital stay, leading to a loss in muscle mass and strength, plays an important role in this fall in functionality. This study aims to examine if a structured and supervised resistance and mobility exercise intervention, can prevent this fall in functional ability during hospital stay among older patients. The Impact of nutritional status will be investigated by registrering caloric, protein and hydtrational intake during the study period.
详细描述
Older persons are highly susceptible to hospital associated disability (HAD), defined by a loss of physical function during hospitalization, leading to increased dependency, morbidity, and mortality. Key factors in developing HAD are physical inactivity, malnutrition and dehydration, leading to a decline in muscle mass and muscle strength. Therefore, there is a need to develop effective nutritional and exercise interventions for older patients, during hospitalization. Hypothesis: This study expects that a mobility-graded individualized exercise intervention will effectively prevent a decline in activities of daily living (ADL) function, mobility level, physical function, muscle and strength, and reduce the length of stay, risk of re-admission and mortality among older patients during hospital stay. The investigators furthermore hypothesize that sufficcient nutrition and hydration will improve the impact of the exercise intervention. The study is designed as a randomized controlled trial, and will include 360 participants, men and women, ≥ 65 years old from the geriatric care unit of Bispebjerg Hospital, Denmark. After inclusion, participants will have estimated nutritional status, frailty and mobility, muscle mass and strength, physical function, ADL function, cognitive function and quality of life. Futhermore, blood samples for analysis of anabolic and inflammatory biomarkers as well as microbiome samples will be taken at baseline testing. After baseline testing, the participants will be divided randomely 1:1 into a control group and an intervention group. All participants will have nutritional and hydrational intake registered and wear accelerometers during the study period. The participants in the intervention group will receive 2 x 30 minutes supervised exercise (resistance and mobility) every day during the stury period. At discharge or transfer from the geriatric care unit, participants will be tested for mobility, muscle mass and strength, physical function, ADL function, cognitive function and quality of life. 1 Month after discharge from hospital, the participants will recieve af telefon interview, reporting on ADL-function, mobility, quality of life and nutritional status. Participants succesfully reached by telephone interview, will be asked further permission for a homevisit, where muscle strength and mass, physical function, mobility, cognitive function and ADL function will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Outcomes at discharge will be measured by a different investigator than at baseline, to mask the baseline measures.
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized at the geriatric ward
- •Speak Danish or English
- •Ability to give informed consent
排除标准
- •Moderate to severe Dementia
- •Manifest delirium
研究组 & 干预措施
Control
The control group will recieve usual care at the geriatric care unit, with mobility exercise performed based on individual preferences and ability, performed by regular care personelle and regular physiotherapy staff.
Exercise intervention
The exercise intervention group will recieve two times 30 minutes of supervised exercise (mobility and resistance exercise) every day during their stay at the geriatrich care unit.
干预措施: Exercise (Other)
结局指标
主要结局
Changes in activities of daily living (ADL) function, by Barthel index-100
时间窗: From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.
describes the level of independence in activities of daily living, score of 0 equals total dependence and a score of 100 equals total independence
次要结局
- Changes in mobility by Cumulated Ambulation Score(From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge)
- Changes in Knee extension strength,(From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.)
- Changes in Hand Grip Strength(From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.)
- Changes in Sit-to-stand performance(From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.)
- Changes in Gait speed(From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.)
- Changes in Quadriceps muscle thickness(From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.)
- Changes in muscle mass(From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.)
- Changes in appetite(From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.)
- Changes in quality of life(From enrollment to discharge/transfer from the geriatric care unit (aproximately 5 days), measured again 1 month after discharge.)
- Readmission 30 days from discharge(From inclusion to 30 days after discharge from hospital)
- Mortality 30 days, 90 days and 1 year after discharge(From inclusion to 1 year after discharge from hospital)
- Changes in municipal care needs at discharge, 1 month and 3 months after discharge(Retrospectively 14 days berfore inclusion to 3 months after discharge from hospital)
- Discharge destination(From inclusion to discharge from hospital (aproximately 5 days after inclusion))
- Physical activity during hospitalization(From inclusion to discharge from hospital (aproximately 5 days after inclusion))
研究者
Charlotte Suetta
Professor
Bispebjerg Hospital
