Functional and Cognitive Impairment Prevention for Elderly Hospitalized Patients

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02300896
• Other study ID #: 23/2014
• Status: Active, not recruiting
• Phase: N/A
• First received: November 19, 2014
• Last updated: September 11, 2017
• Start date: March 2015
• Est. completion date: January 2018

Study information

• Verified date: September 2017
• Source: Fundacion Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 370
• Est. completion date: January 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 74 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Elderly
• Functional Impairment

Intervention

Other:
• Group-based exercise training during hospitalization
Exercise training. Individual program training 5 days a week during hospitalization

Locations

Country	Name	City	State
Spain	Complejo Hospitalario de Navarra. Department of Geriatrics	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Miguel Servet

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in functional status after the intervention (Barthel Index)	Barthel Index	Baseline (Hospital Admiission), 1 and 3 months later
Primary	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	Quality of life (EuroQol Scale)	EuroQol Scale	Baseline (Hospital Admission), 1 and 3 months later
Secondary	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
Secondary	mortality	Days alive since admission to hospital	Baseline (Hospital Admission), 1 and 3 months later
Secondary	Use of health resources	New admissions to Hospital, admission to nursing homes, visits to General Practitioner	Baseline (Hospital Admission), 1 and 3 months later