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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02300896
Other study ID # 23/2014
Secondary ID
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
Health authority
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

Study Design


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
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