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临床试验/NCT03604640
NCT03604640已完成不适用

Physical Training and Health Education in the Prevention of Hospital-associated Functional Impairment in Elderly Patients

Dr. Jose Antonio SERRA-REXACH2 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2018年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
260
试验地点
2
主要终点
Recover basal functional capacity

研究概览

简要总结

The Activity in GEriatric acute CARe (AGECAR) Plus Health Education is a randomized control trial to assess the effectiveness of an intrahospital exercise and health education program during short hospital stays for improving functional capacity of patients aged 75 years or older.

详细描述

This research aims to investigate the effect of a training program using gait and muscle training and health education, over the functional capacity of elderly hospitalized patients.

The Randomized controlled trial with patients hospitalized in the Acute Care Unit of the Geriatric Department. Participants aged 75 years or older admitted for a short hospital stay will be randomly assigned in a four-week block, to either usual care (control) group or an intervention (training group). Participants allocated in the control group will receive standard hospital care. Participants allocated in the intervention group will perform during hospitalization, training program (30 minutes per session, two sessions per day, lower limb strength training, balance training, walking and inspiratory muscle training) and also health education. Health education consists of several informational activities. Each activity session will teach the patient and caregiver how to perform the exercises to ensure they will continue to be performed at home and before discharge the entire session will be devoted to reviewing the entire program. The type, frequency and progression of the exercises to be carried out will be reviewed; they will be explained how to do them at home and given personalized written instructions with illustrations of the exercises. Also, after one month and two months of discharge, the professional with whom they have completed the training will call them to insist on the completion of the program or to clarify any doubts that may exist.

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

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants will include people aged 75 years or older recruited from patients admitted into the Geriatrics Department of the Hospital General Universitario Gregorio Marañón (Madrid, Spain).
  • Able to ambulate, with or without personal/technical assistance.
  • Able to communicate.
  • Informed consent: Must be capable and willing to provide consent.

排除标准

  • Duration of hospitalization < 72 hours
  • Any factor is precluding performance of the physical training program or testing procedures as determined by the attending physician. These factors include, but are not limited to the following:
  • Terminal illness.
  • Not capable of ambulation.
  • Unstable cardiovascular disease or other medical condition.
  • Severe dementia.
  • Unwillingness to either complete the study requirements or to be randomized into control or intervention group.

结局指标

主要结局

Recover basal functional capacity

时间窗: Three months after discharge

Changes in the number of Activities of daily living (ADLs) that the patients could perform independently. The six basic ADLs include: bathing, dressing, toileting, transferring, continence, and eating. For each ADL, a score of 0 is assigned for dependence and 1 for independence. A summary scale is constructed by summing the individual ADLs (range of 0-6). Recovery is defined as performance that is at least as good at discharge or 3-months postdischarge as it was at baseline.

次要结局

  • Ability to walk independently(Three months after discharge)
  • Physical capacity by the Short Physical Performance Battery (SPPB)(Measurements are taken on the day of admission to the study and the day of discharge from the hospital, an average of 6 days of hospital stay.)
  • Physical capacity by the Alusti test(Measurements are taken on the day of admission to the study and the day of discharge from the hospital, an average of 6 days of hospital stay.)
  • Recover basal functional status by Barthel Index of Activities of Daily Living(Three months after discharge)

研究者

发起方
Dr. Jose Antonio SERRA-REXACH
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Jose Antonio SERRA-REXACH

Head Of Geriatry Department

Hospital General Universitario Gregorio Marañon

研究点 (2)

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