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Functional and Cognitive Impairment Prevention for Elderly Hospitalized Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02300896
Enrollment
370
Registered
2014-11-25
Start date
2015-03-31
Completion date
2018-01-31
Last updated
2017-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Elderly, Functional Impairment

Keywords

exercise, physical fitness, geriatrics

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.

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.

Interventions

Exercise training. Individual program training 5 days a week during hospitalization

Sponsors

Fundacion Miguel Servet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
74 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in functional status after the intervention (Barthel Index)Baseline (Hospital Admiission), 1 and 3 months laterBarthel Index
Changes in functional status after the intervention (Mini Mental State Evaluation, GDS Yesavage, Trail Making Test)Baseline (Hospital Admiission) and 1 and 3 months laterMini Mental State Evaluation, GDS Yesavage, Trail Making Test

Secondary

MeasureTime frameDescription
Quality of life (EuroQol Scale)Baseline (Hospital Admission), 1 and 3 months laterEuroQol Scale
delirium (Confusion Assessment Method, Delirium Rating Scale-Revised-98)Baseline (Hospital Admission),1 and 3 months laterConfusion Assessment Method, Delirium Rating Scale-Revised-98
mortalityBaseline (Hospital Admission), 1 and 3 months laterDays alive since admission to hospital
Use of health resourcesBaseline (Hospital Admission), 1 and 3 months laterNew admissions to Hospital, admission to nursing homes, visits to General Practitioner

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026