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Functional and Cognitive Impairment Prevention for Elderly Hospitalized Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02300896
Recruitment Status : Active, not recruiting
First Posted : November 25, 2014
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Fundacion Miguel Servet

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Functional Impairment Cognitive Impairment Elderly Other: Group-based exercise training during hospitalization Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Functional and Cognitive Impairment Prevention Through Early Physical Activity for Elderly Hospitalized Patients: a Randomized Clinical Trial
Study Start Date : March 2015
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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
Exercise training. Individual program training 5 days a week during hospitalization

No Intervention: Control
Usual care including rehabilitation when necessary



Primary Outcome Measures :
  1. Changes in functional status after the intervention (Barthel Index) [ Time Frame: Baseline (Hospital Admiission), 1 and 3 months later ]
    Barthel Index

  2. Changes in functional status after the intervention (Mini Mental State Evaluation, GDS Yesavage, Trail Making Test) [ Time Frame: Baseline (Hospital Admiission) and 1 and 3 months later ]
    Mini Mental State Evaluation, GDS Yesavage, Trail Making Test


Secondary Outcome Measures :
  1. Quality of life (EuroQol Scale) [ Time Frame: Baseline (Hospital Admission), 1 and 3 months later ]
    EuroQol Scale

  2. delirium (Confusion Assessment Method, Delirium Rating Scale-Revised-98) [ Time Frame: Baseline (Hospital Admission),1 and 3 months later ]
    Confusion Assessment Method, Delirium Rating Scale-Revised-98

  3. mortality [ Time Frame: Baseline (Hospital Admission), 1 and 3 months later ]
    Days alive since admission to hospital

  4. Use of health resources [ Time Frame: Baseline (Hospital Admission), 1 and 3 months later ]
    New admissions to Hospital, admission to nursing homes, visits to General Practitioner



Information from the National Library of Medicine

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Ages Eligible for Study:   74 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300896


Locations
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Spain
Complejo Hospitalario de Navarra. Department of Geriatrics
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Fundacion Miguel Servet
Investigators
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Principal Investigator: Nicolas Martínez-Velilla, PhD Complejo Hospitalario de Navarra

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundacion Miguel Servet
ClinicalTrials.gov Identifier: NCT02300896     History of Changes
Other Study ID Numbers: 23/2014
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017

Keywords provided by Fundacion Miguel Servet:
exercise
physical fitness
geriatrics

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders