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Functional and Cognitive Impairment Prevention for Elderly Hospitalized Patients

F

Fundacion Miguel Servet

Status

Unknown

Conditions

Cognitive Impairment
Elderly
Functional Impairment

Treatments

Other: Group-based exercise training during hospitalization

Study type

Interventional

Funder types

Other

Identifiers

NCT02300896
23/2014

Details and patient eligibility

About

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.

Full description

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.

Enrollment

370 estimated patients

Sex

All

Ages

74+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

370 participants in 2 patient groups

Intervention
Experimental group
Description:
Group-based exercise training during hospitalization Procedure: Exercise training. Individual program training 5 days a week during hospitalization
Treatment:
Other: Group-based exercise training during hospitalization
Control
No Intervention group
Description:
Usual care including rehabilitation when necessary

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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