Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline, in Elderly Patients Undergoing Urgent Abdominal Surgery: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 218
- 主要终点
- Changes in Cognitive capacity of patients
研究概览
简要总结
Older adults, especially those with frailty, have a higher risk for complications, functional and cognitive decline after urgent surgery.
These patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. The consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, poor quality of life and increased use of resources related to health. Exercise training can prevent functional and cognitive decline and modify even the posterior trajectory
详细描述
This study is a randomized clinical trial conducted in the Department of Surgery of a tertiary public hospital. Patients undergoing urgent abdominal surgery who meet inclusion criteria will be randomly assigned to the intervention or control group. A total of 218 elderly patients undergoing urgent abdominal surgery( control group=109 and intervention group 109) randomly assigned to the intervention or control group.
Patient recruitment will begin in the 4-day after the surgical procedure, which will be identified through the list of patients admitted to the hospital and assigned to the Department. The doctor who decides the inclusion in the intervention or control group will not be the attending physician. Patients or their families (if the patient has cognitive impairment) will be informed of the random inclusion in one group, but will not be informed as to which they belong. Randomization will be performed by applying http://www.randomizer.org/. The information in both the intervention group and the control group will obtained in four different stages: the initial visit and at months 1, 3 and 6 after hospital discharge.
The intervention will consist of a multicomponent exercise training program, which will composed of supervised progressive resistance exercise training, aerobic and anaerobic exercises. This training period consist on 2 training sessions per week during 4 weeks after one week of discharge.
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
- Single (Investigator)
盲法说明
The study participants will be randomized ( ww. randomizer.org) into an intervention group and a control group. the assessment staff will be blinded to the participant randomization assignment, as well as to the main study design ant to what changes we expect to occur in the study outcomes in either group.
It will not be possible to conceal the group assignment from the staff involved in the training of the intervention group.
入排标准
- 年龄范围
- 70 Years 至 105 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 70 years and older
- •Able to tolerate exercise
- •Able to ambulate, with or without personal / technical assistance or move unassisted in a wheelchair
- •Able to communicate
- •Undergoing urgent abdominal surgery
- •Barthel Index>60
- •Informed consent: must be capable and willing to provide consent
排除标准
- •Severe dementia (GDS 7)
- •Duration of hospitalization <4 days
- •Unwillingness to either complete the study requirements or to be randomized into control or intervention group
- •Unstable cardiovascular disease or other unstable medical condition
- •Terminal illness
- •Myocardial infarction in the past 3 months
- •Upper or lower extremity fracture in the past 3 months
- •Evisceration
结局指标
主要结局
Changes in Cognitive capacity of patients
时间窗: 1, 3 and 6 months after hospitalization discharge
The cognitive-affective status will be measured in the follow up using the Mini Mental State Examination.nThis examination is composed of seven categories designed to assess specific cognitive functions: orientation to time (5 points), orientation to place (5 points), registration of three words (3 points), attention and calculation (5 points), recalling the three words (3 points), language (8 points) and constructive visual capacity (1 point). The MMSE score ranges from zero to 30 points, and lower values indicate possible cognitive deficit
Changes in functional capacity of patients
时间窗: 1, 3 and 6 months after hospitalization discharge
The functional capacity of patients will be evaluated by the Short Physical Performance Battery (SPPB), which evaluates, balance, gait ability, and leg strength using a single tool. The total score will range from 0 (worst) to 12 points (best).
Changes in Quality of life
时间窗: 1, 3 and 6 months after hospitalization discharge
Changes in Quality of life will be evaluated by European Quality of Life-5 Dimensions (EuroQol- 5D). European Quality of Life-5 Dimensions: comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels, the score will range from 5 (wort) to 15 (best).
Changes in Visual Analogue Scale
时间窗: 1, 3 and 6 months after hospitalization discharge
Changes in Visual Analogue Scale (VAS). The VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' (100 points) and 'The worst health you can imagine'(0 points).
次要结局
- Mortality(30 and 90-day)
- Length of stay(from the date of admission until the date of discharge)
- Cost per quality-adjusted life year(6 months post-discharge)
- Postoperative complications(30 and 90-day)
- Delirium(from the date of admission until the date of discharge)
研究者
IRENE ESQUIROZ
Principal Investigator
Hospital of Navarra