Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline, in Elderly Patients Undergoing Urgent Abdominal Surgery: A Randomized Clinical Trial

Conditions
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Surgery--Complications

Intervention / Treatment
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* Other: Individualized exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized clinical trial,patient who meet the inclusion criteria will be randomly assigned to the intervention or control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Individualized exercise training<br>Exercise training. Individual program training 2 days per week during 4 week, after one week of discharge | Other: Individualized exercise training<br>* 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 of 40 minutes (Warm up 5´+ aerobic exercise 15´+ anaerobic exercise 15´+ stretching 5´)per week during 4 weeks after one week of discharge<br>|
| No Intervention: No Intervention: Control<br>Usual care including rehabilitation when necessary | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in functional capacity of patients | 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). | 1, 3 and 6 months after hospitalization discharge | 
| Changes in Cognitive capacity of patients | 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 | 1, 3 and 6 months after hospitalization discharge | 
| Changes in Quality of life | 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). | 1, 3 and 6 months after hospitalization discharge | 
| Changes in Visual Analogue Scale | 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). | 1, 3 and 6 months after hospitalization discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Comprehensive Complication Index | 30 and 90-day | 
| Length of stay | Length of stay | from the date of admission until the date of discharge | 
| Mortality | postoperative mortality | 30 and 90-day | 
| Delirium | Confusion Assessment Method (CAM) The CAM short form assesses four features: 1. acute onset or fluctuating course, 2. inattention, 3. disorganized thinking, and 4. altered level of consciousness. For the diagnosis of delirium, the first two criteria and at least one of the last two are necessary. | from the date of admission until the date of discharge | 
| Cost per quality-adjusted life year | Both direct and indirect study participant costs | 6 months post-discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly patients, Exercises, Cognitive Dysfunction, Quality of life