Preventing Loss of Weight, Fat Free Mass and Activities of Daily Living
Primary Purpose
Hip Fracture, Arthrosis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Involving the patients in their own nutritional care
Sponsored by
About this trial
This is an interventional prevention trial for Hip Fracture focused on measuring Activities of daily living, Elderly, Nutrition, Postoperative, Hip fractures, Hip replacement, Knee replacement
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.
Sites / Locations
- County hopital of Koge
Outcomes
Primary Outcome Measures
Changes in weight
Changes in Fatt Free Mass
Changes in ADL-activities
Secondary Outcome Measures
energy intake
Protein intake
Full Information
NCT ID
NCT00373971
First Posted
September 7, 2006
Last Updated
September 7, 2006
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT00373971
Brief Title
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
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
November 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 1998 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture, Arthrosis
Keywords
Activities of daily living, Elderly, Nutrition, Postoperative, Hip fractures, Hip replacement, Knee replacement
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
252 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Involving the patients in their own nutritional care
Primary Outcome Measure Information:
Title
Changes in weight
Title
Changes in Fatt Free Mass
Title
Changes in ADL-activities
Secondary Outcome Measure Information:
Title
energy intake
Title
Protein intake
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Preben U Pedersen, phd
Official's Role
Principal Investigator
Facility Information:
Facility Name
County hopital of Koge
City
Koge
ZIP/Postal Code
4600
Country
Denmark
12. IPD Sharing Statement
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Preventing Loss of Weight, Fat Free Mass and Activities of Daily Living
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