Functional and Cognitive Impairment Prevention for Elderly Hospitalized Patients

September 11, 2017 updated by: Fundacion Miguel Servet

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

370

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Complejo Hospitalario de Navarra. Department of Geriatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

74 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in functional status after the intervention (Barthel Index)
Time Frame: Baseline (Hospital Admiission), 1 and 3 months later
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)
Time Frame: Baseline (Hospital Admiission) and 1 and 3 months later
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)
Time Frame: Baseline (Hospital Admission), 1 and 3 months later
EuroQol Scale
Baseline (Hospital Admission), 1 and 3 months later
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
Baseline (Hospital Admission),1 and 3 months later
mortality
Time Frame: Baseline (Hospital Admission), 1 and 3 months later
Days alive since admission to hospital
Baseline (Hospital Admission), 1 and 3 months later
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
Baseline (Hospital Admission), 1 and 3 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Miguel Servet

Investigators

  • Principal Investigator: Nicolas Martínez-Velilla, PhD, Complejo Hospitalario de Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

September 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

November 19, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (Estimate)

November 25, 2014

Study Record Updates

Last Update Posted (Actual)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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