Clinical trial NCT00373971: Preventing Loss of Weight, Fat Free Mass and Activities of Daily Living
Official title: Nutritional Care - Preventing Loss of Weight, Fat Free Mass and Activities of Daily Living Four Months After Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Arthrosis
Keywords: Activities of daily living
Elderly
Nutrition
Postoperative
Hip fractures
Hip replacement
Knee replacement
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2006-09-08
Enrollment: 252
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in weight
measure: Changes in Fatt Free Mass
measure: Changes in ADL-activities
Secondary outcomes:
measure: energy intake
measure: Protein intake
Other outcomes:
Locations:
city: Koge
country: Denmark
facility: County hopital of Koge
Study officials:
name: Preben U Pedersen, phd
role: PRINCIPAL_INVESTIGATOR
References: