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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02062541
Other study ID # SLB-ED-02-2014
Secondary ID
Status Completed
Phase N/A
First received February 12, 2014
Last updated February 1, 2017
Start date June 2015
Est. completion date January 2017

Study information

Verified date February 2017
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: Illness and hospitalisation, even of short duration, pose separate risks for permanently reduced functional performance in elderly medical patients. Functional assessment in the acute pathway will ensure early detection of declining performance and form the basis for mobilisation during hospitalisation and subsequent rehabilitation. For optimal results rehabilitation should begin immediately after discharge.

The aim of this study is to investigate the effect of a systematic functional assessment in the emergency departments (ED) of elderly medical patients with reduced functional performance when combined with immediate post-discharge rehabilitation.

Method/design: The study is a two-way factorial randomised clinical trial. Participants will be recruited among patients admitted to the ED who are above 65 years of age with reduced functional performance. Patients will be randomly assigned to one of four groups: 1) functional assessment and immediate rehabilitation; 2) functional assessment and usual rehabilitation; 3) usual assessment and immediate rehabilitation; 4) usual assessment and usual rehabilitation.

Primary outcome: 30-second chair-stand test administered at admission and two weeks after discharge.

We hypothesise that such assessment in the ED or/and immediate rehabilitation will result in sustained or improved performance in comparison to regimen in which neither of these interventions are offered.


Recruitment information / eligibility

Status Completed
Enrollment 336
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- medical patients of 65 years of age or older admitted to the ED

- Can speak and understand Danish

- Resident in either of the two included municipalities

- Can report personal data and decide on consent

- Are able to sit on an chair and perform = 9 repetitions at the 30-s. chair-stand test

Exclusion Criteria:

- Patients suffering from a progressive neurological or cognitive deficit or disease.

- Patients ordinarily unable to walk

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Funct. assessment+fast rehabilitation

Funct. assessment+usual rehabilitation

usual assessment+fast rehabilitation


Locations

Country Name City State
Denmark Lillebaelt hospital Kolding

Sponsors (2)

Lead Sponsor Collaborator
University of Southern Denmark Sygehus Lillebaelt

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 30-second-chair-stand test up to 14 days after admission date
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