Hip FractureNCT00373971
Preventing Loss of Weight, Fat Free Mass and Activities of Daily Living
A study testing Involving the patients in their own nutritional care in people with Hip Fracture and Arthrosis, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture, Arthrosis
- What is being tested?
- Involving the patients in their own nutritional care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 252 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 1995to Jul 1998
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Care - Preventing Loss of Weight, Fat Free Mass and Activities of Daily Living Four Months After Surgery.
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.
Read the 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.
- Conditions
- Hip Fracture, Arthrosis
- Being tested
- Involving the patients in their own nutritional care
- Keywords
- Activities of daily living, Elderly, Nutrition, Postoperative, Hip fractures, Hip replacement, Knee replacement
- Medical subject headings
- Hip Fractures, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Involving the patients in their own nutritional careBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in weight
Changes in Fatt Free Mass
Changes in ADL-activities
Secondary outcomes (2)
energy intake
Protein intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startNov 1995
- Study completionJul 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 252 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Preben U Pedersen, phd, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373971
- Sponsor's protocol ID
- 1995-1-62
- Status last verified
- Sep 2006
- First submitted
- 7 Sep 2006
- Last updated
- 8 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Care - Preventing Loss of Weight, Fat Free Mass and Activities of Daily Living Four Months After Surgery.
- ClinicalTrials.gov ID
- NCT00373971
- Acronym / sponsor ID
- 1995-1-62
- Conditions
- Hip Fracture, Arthrosis
- Keywords
- Activities of daily living, Elderly, Nutrition, Postoperative, Hip fractures, Hip replacement, Knee replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 1995
- Study completion
- Jul 1998
- First posted
- 8 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Involving the patients in their own nutritional care | Behavioural | – |
Primary outcome
Changes in weight
Changes in Fatt Free Mass
Changes in ADL-activities
2 secondary outcomes
energy intake
Protein intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Preben U Pedersen, phd principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Involving the patients in their own nutritional care in people with Hip Fracture and Arthrosis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in weight. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2006.