The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital (OLPADIS)
2020年8月3日 更新者：Sylvia Sunde、Oslo Metropolitan University
Effect of a Multi-Component Exercise Program on Function and Health in Older People Recently Discharged From Hospital. A Randomized Controlled Clinical Trial.
The aim of this study is to investigate the effect of a multi-component exercise program on physical function, physical activity and health-related quality of life (HRQOL) in older people recently discharged from hospital.
The intervention consists of 32 group-based exercise sessions, performed twice a week.
In addition the participants in the intervention group will be encouraged to perform an exercise program on their own, at least once weekly.
The participants in the control group will be encouraged to exercise on their own, according to the World Health Organization (WHO) recommendations on physical activity for adults aged 65 and above.
研究概览
详细说明
Older people who have been hospitalized often experience loss of function, increased risk of falls and reduced health-related quality of life (HRQOL) in the post-discharge period.
The reason for this is the cumulative effect of illness, bedrest during hospital stay and inactivity after discharge.
Previous research indicates that exercise therapy should be an integrated part of the post-hospital treatment to prevent or postpone this functional decline and improve HRQOL.
Therefore, the investigators will conduct a randomized controlled trial to investigate the effect of a multi-component exercise program consisting of high intensity exercises on physical function, physical activity and HRQOL among older people living at home after discharge from hospital after treatment of an acute medical event.
研究类型
介入性
注册 (实际的)
88
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Oslo、挪威、0370
- Diakonhjemmet Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
65年 及以上 (年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 65 years or older, live in their own home, consent to participate in the program three times a week (twice a week outside their home), manage to walk with or without assistive device, and assessed by a doctor as able to tolerate the intervention.
Exclusion Criteria:
- Severe cognitive impairment (Mini-Mental State Examination (MMSE) score less than 20), have an expected lifespan less than one year, exercise more than twice a week, and score above nine points on the Short Physical Performance Battery.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Exercise
This group will perform a multi-component exercise program twice a week for 16 weeks.
The multi-component exercise program consists of endurance training, progressive strength exercises and balance exercises.
The intervention will be individualised, but performed in groups of four to ten patients.
The participants are also expected to do exercises on their own, at least once weekly.
|
A multi-component exercise program that consists of endurance training, progressive strength exercises and balance exercises.
|
|
无干预：Control
The participants in the control group will be encouraged to exercise on their own, according to the World Health Organization recommendations on physical activity for adults aged 65 and above.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in physical function
大体时间：Baseline, 4 months and 8 months
|
Changes in physical function will be measured with The Short Physical Performance Battery (SPPB).
This test evaluates balance, mobility and muscle strength by examining an individual's ability to stand with feet together side-by side, semitandem and tandem positions, time to walk 8ft and time to rise from a chair and return to the seated position five times.
Each of the three tests is scored, based on performance between 0 and 4, leaving a maximum score of 12 for those individuals performing at the highest levels.
|
Baseline, 4 months and 8 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Berg Balance Scale
大体时间：Baseline, 4 months and 8 months
|
Berg Balance Scale is a measure of performance-based balance.
It comprises 14 observable tasks frequently encountered in everyday life.
|
Baseline, 4 months and 8 months
|
|
Health-related quality of life (HRQOL)
大体时间：Baseline, 4 months and 8 months
|
HRQOL measured by the Medical Outcome Study 36 Item Short-Form Health Survey (SF-36)
|
Baseline, 4 months and 8 months
|
|
Physical Activity measured by the short form of the International Physical Activity Questionnaire (IPAQ-SF)
大体时间：Baseline, 4 months and 8 months
|
The IPAQ-SF includes seven questions about the time spent in vigorous- and moderate intensity activities, walking and sedentary activity.
|
Baseline, 4 months and 8 months
|
|
Muscle mass
大体时间：Baseline, 4 months and 8 months
|
Muscle mass will be measured by bioimpedance
|
Baseline, 4 months and 8 months
|
|
Compliance to the intervention
大体时间：Eight months from baseline
|
Participants will complete an activity diary where they are asked to report completion of exercise, non-protocol activity and any adverse events related to the exercise.
Patients are considered non-compliant if they have undertaken less than 50% of the prescribed exercise.
|
Eight months from baseline
|
|
Feasibility of the intervention
大体时间：Four months from baseline
|
Adverse events will be registered as outlined by Oryet al. (2005) in the following four categories: falls, cardiovascular events, musculoskeletal injuries and health care utilization.
|
Four months from baseline
|
|
Amount of home-help services received
大体时间：Baseline, 4 months and 8 months
|
If they receive any home care
|
Baseline, 4 months and 8 months
|
|
Handgrip strength
大体时间：Baseline, 4 months and 8 months
|
Handgrip strength in kilograms measured using a hydraulic dynamometer
|
Baseline, 4 months and 8 months
|
|
Height
大体时间：Baseline
|
Height will be measured in meters
|
Baseline
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Therese Brovold, Phd、Oslo University College of Applied Science
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Sunde S, Hesseberg K, Skelton DA, Ranhoff AH, Pripp AH, Aaronaes M, Brovold T. Associations between health-related quality of life and physical function in older adults with or at risk of mobility disability after discharge from the hospital. Eur Geriatr Med. 2021 Dec;12(6):1247-1256. doi: 10.1007/s41999-021-00525-0. Epub 2021 Jun 9.
- Sunde S, Hesseberg K, Skelton DA, Ranhoff AH, Pripp AH, Aaronaes M, Brovold T. Effects of a multicomponent high intensity exercise program on physical function and health-related quality of life in older adults with or at risk of mobility disability after discharge from hospital: a randomised controlled trial. BMC Geriatr. 2020 Nov 11;20(1):464. doi: 10.1186/s12877-020-01829-9.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年9月29日
初级完成 (实际的)
2020年1月30日
研究完成 (实际的)
2020年1月30日
研究注册日期
首次提交
2016年9月5日
首先提交符合 QC 标准的
2016年9月13日
首次发布 (估计)
2016年9月19日
研究记录更新
最后更新发布 (实际的)
2020年8月4日
上次提交的符合 QC 标准的更新
2020年8月3日
最后验证
2020年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Exercise的临床试验
-
University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的