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

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00373971
First received: September 7, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Nutritional Care – Preventing Loss of Weight, Fat Free Mass and Activities of Daily Living Four Months After Surgery.

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00373971     History of Changes
Other Study ID Numbers: 1995-1-62
Study First Received: September 7, 2006
Last Updated: September 7, 2006
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

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Joint Diseases
Osteoarthritis
Weight Loss
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014