Preventing Loss of Weight, Fat Free Mass and Activities of Daily Living

Hip Fracture Clinical Trial

Official title:

Nutritional Care – Preventing Loss of Weight, Fat Free Mass and Activities of Daily Living Four Months After Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373971
• Other study ID #: 1995-1-62
• 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
• 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

• Arthrosis
• Hip Fracture
• Hip Fractures
• Weight Loss

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