Preventing Loss of Weight, Fat Free Mass and Activities of Daily Living - Full Text View

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00373971

Purpose

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.

Condition	Intervention
Hip Fracture Arthrosis	Behavioral: Involving the patients in their own nutritional care

MedlinePlus related topics: Fractures Hip Injuries and Disorders Hip Replacement Nutritional Support Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study
Official Title:	Nutritional Care – Preventing Loss of Weight, Fat Free Mass and Activities of Daily Living Four Months After Surgery.

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Changes in weight
Changes in Fatt Free Mass
Changes in ADL-activities

Secondary Outcome Measures:

energy intake
Protein intake

Estimated Enrollment:	252
Study Start Date:	November 1995
Estimated Study Completion Date:	July 1998

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

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373971

Locations

Denmark
County hopital of Koge
Koge, Denmark, 4600

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator:

Preben U Pedersen, phd

Unaffiliated

More Information

No publications provided

Study ID Numbers:	1995-1-62
Study First Received:	September 7, 2006
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00373971 History of Changes
Health Authority:	Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:

Activities of daily living
Elderly
Nutrition
Postoperative

Hip fractures
Hip replacement
Knee replacement

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Hip Fractures
Femoral Fractures
Joint Diseases
Weight Loss

Fractures, Bone
Body Weight Changes
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Hip Fractures
Femoral Fractures
Fractures, Bone
Weight Loss

Body Weight Changes
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries
Hip Injuries

ClinicalTrials.gov processed this record on May 06, 2009