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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00373971
Other study ID # 1995-1-62
Secondary ID
Status Completed
Phase N/A
First received September 7, 2006
Last updated September 7, 2006
Start date November 1995
Est. completion date July 1998

Study information

Verified date September 2006
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial Summary

Malnutrition of elder orthopaedic patients leads to weight loss and loss of fat free mass. Changes in the individual’s nutritional status and body composition may adversely affect the patient’s postoperative level of activity.

Aim. Thus, the purpose of the present study is to report changes in postoperative weight, FFM and functions vital to daily living in a group of elder orthopaedic patients that were actively involved in their nutritional care during the hospital stay.


Description:

Malnutrition of elder orthopaedic patients leads to weight loss and loss of fat free mass. Changes in the individual’s nutritional status and body composition may adversely affect the patient’s postoperative level of activity.

Aim. Thus, the purpose of the present study is to report changes in postoperative weight, FFM and functions vital to daily living in a group of elder orthopaedic patients that were actively involved in their nutritional care during the hospital stay.

Method. The study comprises 253 patients aged 65+ and admitted either for hip- or knee replacement or with a fractured hip. Following a quasi-experimental design, 142 patients were allocated to the control group and 109 patients to the intervention group. The intervention programme focused on patients’ involvement in their nutritional care. Body composition by bio impedance and functional status by a standard chart were assessed at admission and four months postoperatively.


Recruitment information / eligibility

Status Completed
Enrollment 252
Est. completion date July 1998
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Aged 65 and above admitted either for elective hip- or knee replacement or acute with a fractured hip were allocated to the study. Patients included in the study were to stay in hospital for more than 7 days and agree on coming to the outpatient clinic for a follow-up four months after surgery.

Exclusion Criteria:

- Patients who refused to participate, patients were not able to understand the instructions,or received dietary treatment due to DM. Patients who suffered from cancer, gastrointestinal disorders or were undergoing steroid treatment. In addition, patients who were unable to participate due to serious heart disorders; or were transferred to intensive or cardiac units after surgery and did not return to the ward.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Involving the patients in their own nutritional care


Locations

Country Name City State
Denmark County hopital of Koge Koge

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in weight
Primary Changes in Fatt Free Mass
Primary Changes in ADL-activities
Secondary energy intake
Secondary Protein intake
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