Cognitive Impairment Clinical Trial
Official title:
Functional and Cognitive Impairment Prevention Through Early Physical Activity for Elderly Hospitalized Patients: a Randomized Clinical Trial
Verified date | September 2017 |
Source | Fundacion Miguel Servet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Complejo Hospitalario de Navarra. Department of Geriatrics | Pamplona | Navarra |
Lead Sponsor | Collaborator |
---|---|
Fundacion Miguel Servet |
Spain,
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 |
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