Functional and Cognitive Impairment Prevention for Elderly Hospitalized Patients

Study Overview
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Brief Summary
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The current model of care for the hospitalized elderly patients has been conditioned by many factors unrelated to the disease process that caused the hospitalization and usually worsen the outcome of hospitalization circumstances. Many times hospitalized elderly patients spend most of the time in bed (even higher than 83% of bed rest versus 4% of those who stand or are walking). 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, deconditioning, pressure ulcers and decreased caloric intake, social isolation, 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 a Department of Geriatrics of a tertiary public hospital with 35 beds allocated. Hospitalized patients who meet the inclusion criteria will be randomly assigned to intervention or control group. Patient recruitment will begin in the first 48 hours of admission to the ward, which will be identified through the list of patients admitted to the hospital and assigned to the Department of Geriatrics. 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 3, 6 and 12 after hospital discharge.

Official Title
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Functional and Cognitive Impairment Prevention Through Early Physical Activity for Elderly Hospitalized Patients: a Randomized Clinical Trial

Conditions
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Functional Impairment, Cognitive Impairment, Elderly

Intervention / Treatment
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* Other: Group-based exercise training during hospitalization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 75 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 Non-elective admission to hospital Exclusion Criteria: Severe dementia (GDS 7) Duration of hospitalization <72 hours 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

Ages Eligible for Study
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Minimum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Group-based exercise training during hospitalization Procedure: Exercise training. Individual program training 5 days a week during hospitalization | Other: Group-based exercise training during hospitalization<br>* Exercise training. Individual program training 5 days a week during hospitalization<br>|
| 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 status after the intervention (Barthel Index) | Barthel Index | Baseline (Hospital Admiission), 1 and 3 months later | 
| Changes in functional status after the intervention (Mini Mental State Evaluation, GDS Yesavage, Trail Making Test) | Mini Mental State Evaluation, GDS Yesavage, Trail Making Test | Baseline (Hospital Admiission) and 1 and 3 months later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (EuroQol Scale) | EuroQol Scale | Baseline (Hospital Admission), 1 and 3 months later | 
| delirium (Confusion Assessment Method, Delirium Rating Scale-Revised-98) | Confusion Assessment Method, Delirium Rating Scale-Revised-98 | Baseline (Hospital Admission),1 and 3 months later | 
| mortality | Days alive since admission to hospital | Baseline (Hospital Admission), 1 and 3 months later | 
| Use of health resources | New admissions to Hospital, admission to nursing homes, visits to General Practitioner | Baseline (Hospital Admission), 1 and 3 months later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, physical fitness, geriatrics