- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06304584
Cross-sectoral Rehabilitation of Older High-risk Patients With Hip Fracture
Rehabilitation of Older High-risk Patients Treated for a Fragility Fracture of the Hip - a Cross-sectoral Study Between Bispebjerg-Frederiksberg Hospital and Frederiksberg Municipality - The HipFracture-Rehab1 Project
The goal of this observational study is to learn about and monitor the cross-sectoral rehabilitation process in older high-risk patients treated for at fragility fracture of the hip.
The main questions aim to answer:
- how patients are doing up to one year after hip fracture surgery on different outcomes across the continuum of rehabilitation being offered
- what expectations, experiences and satisfaction patients have for the overall rehabilitation process after a hip fracture
Participants age 65 and above with home address in Frederiksberg municipality, living in own home, admitted and treated for at hip fracture at Department of Orthopedic Surgery, Bispebjerg Hospital, will be asked for participation.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Morten T Kristensen, Professor
- Phone Number: +4526152433
- Email: morten.tange.kristensen@regionh.dk
Study Contact Backup
- Name: Camilla K Zilmer, MSc, PT
- Email: camilla.kampp.zilmer@regionh.dk
Study Locations
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Copenhagen, Denmark, 2400
- Recruiting
- Department of Physio- and Occupational Therapy and Othopedic Surgery, University Hospital Bispebjerg and Frederiksberg
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Contact:
- Camilla K Zilmer, MSc, PT
- Email: camilla.kampp.zilmer@regionh.dk
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Contact:
- Morten T Kristensen, Professor
- Email: morten.tange.kristensen@regionh.dk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Undergone surgery for hip fracture and admitted to department M1, Bispebjerg-Frederiksberg Hospital
Living in Frederiksberg municipality and being admitted from own home, or a 24 hour temporary setting in the municipality
Exclusion Criteria:
Living permanent in nursing home or is on the way to a permanent nursing home from a 24-hour setting.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recovery of pre-fracture function
Time Frame: Recovery of pre-fracture function at 3-4 months post-fracture as primary outcome
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Recovery of function related to the pre-fracture level (re-call last week before fracture) will be assessed with New mobility Score (score 0-9) pre-fracture, at start and end of rehabilitation in municipality, 3-4 month and 1 year post-fracture
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Recovery of pre-fracture function at 3-4 months post-fracture as primary outcome
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive status
Time Frame: At inclusion
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Will be assessed using the Short Orientation-Memory Concentration (OMC).
It consists of a 6-item patient reported questionnaire and is validated as a measure of cognitive impairment.
The score ranges from 0-28 where 0 is equal to normal cognition and 28 is appraised as a severe impairment.
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At inclusion
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Comorbidity
Time Frame: At inclusion
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Will be assessed using The American Society of Anesthesiologists (ASA) physical status classification system.
The ASA score is a subjective assessment of a patient's overall health that is based on five classes.
One means the patients is healthy and fit, and 5 is a moribund patient who is not expected to live 24 hour with or without surgery.
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At inclusion
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Basic mobility
Time Frame: Pre-fracture, at inclusion and discharge from hospital, at start and end of rehabilitation in municipality, 3-4 months and 1 year post-fracture
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Will be measured using Cumulated Ambulation Score (CAS).
It describes the patients' independence in three activities (getting in and out of bed, sit-to-stand from a chair, and walking), with each activity assessed on a three-point ordinal scale from 0 to 2, resulting in a total CAS between 0 and 6 (6 is maximum score indicating the patient to be independent in basic mobility).
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Pre-fracture, at inclusion and discharge from hospital, at start and end of rehabilitation in municipality, 3-4 months and 1 year post-fracture
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30 second chair stand test (CST)
Time Frame: At inclusion and discharge from hospital, at start and end of rehabilitation in municipality and 3-4 months post-fracture
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CST test measures how many times a person can stand up from a chair in 30 seconds, without using their arms.
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At inclusion and discharge from hospital, at start and end of rehabilitation in municipality and 3-4 months post-fracture
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Timed Up & Go test (TUG)
Time Frame: At start and end of rehabilitation in municipality and 3-4 months post-fracture
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TUG test measures the time in seconds it takes a person to stand up from a regular chair with back and armrests, walk 3 meters, turn around, go back to the chair and sit down again
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At start and end of rehabilitation in municipality and 3-4 months post-fracture
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Hip related pain
Time Frame: At inclusion and discharge from hospital, at start and end of rehabilitation in municipality, 3-4 months and 1 year post-fracture
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Will be assessed using the 5-point Verbal Rating Scale (VRS, no pain, slight pain, moderate pain, severe pain, and unbearable pain) during weight-bearing activities
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At inclusion and discharge from hospital, at start and end of rehabilitation in municipality, 3-4 months and 1 year post-fracture
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Hand Grip Strength (HGS)
Time Frame: At inclusion at the hospital, at start and end of rehabilitation in municipality and 3-4 months post-fracture
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HGS measures how much strength a person has in their dominant hand.
If the dominant hand is injured (e.g. by paralysis or fracture), the test is carried out with the non-dominant hand.
Although the measure of HGS assesses the function of one muscle group, it is regarded as an indicator of overall body strength.
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At inclusion at the hospital, at start and end of rehabilitation in municipality and 3-4 months post-fracture
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Health questionnaire
Time Frame: At pre-fracture (recall) and 3-4 months and 1-year post-fracture
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Will be assessed by the EQ-5D-5L questionnaire.
The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
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At pre-fracture (recall) and 3-4 months and 1-year post-fracture
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Physical activity (weekly)
Time Frame: At inclusion (recall of the last few weeks before present hospitalization) and 1-year post-fracture
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Will be assessed using a validated questionnaire from the Swedish National Board of Health and Welfare, providing a total score from 3 to 19.
A score ≥11 corresponds to fulfillment of the Word Health Organization's recommendation for weekly physical activity
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At inclusion (recall of the last few weeks before present hospitalization) and 1-year post-fracture
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Physical activity / upright time (time standing and walking)
Time Frame: From inclusion until 9 days post-discharge
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Will be measured using SENS Innovation Aps motion activity measurement system which is a waterproof activity sensor placed laterally on the opposite thigh of the fractured hip.
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From inclusion until 9 days post-discharge
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Frailty
Time Frame: At pre-fracture (recall) and 1-year post-fracture
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Will be assessed using Clinical Frailty Scale (CFS) which is a clinical judgement-based frailty tool.
The CFS evaluates specific domains including comorbidity, function., and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill).
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At pre-fracture (recall) and 1-year post-fracture
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Fear of falling
Time Frame: At discharge and 3-4 months and 1-year post-fracture
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Will be assessed with Short-Falls Efficacy Scale, minimum 7 (no concern about falling) to maximum 28 (severe concern about falling).
Assesses fear of falling conceptualized as concerns about falling in an 7 item questionnaire.
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At discharge and 3-4 months and 1-year post-fracture
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Number of falls
Time Frame: At start and end of rehabilitation in municipality, 3-4 months and 1 year post-fracture
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Place and cause
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At start and end of rehabilitation in municipality, 3-4 months and 1 year post-fracture
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Residential status / discharge destination
Time Frame: At discharge from hospital and 24-hour rehabilitation setting
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Residential status pre-fracture and discharge destination
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At discharge from hospital and 24-hour rehabilitation setting
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Length of stay in acute hospital
Time Frame: From surgery till discharge
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Number of days
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From surgery till discharge
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Number of weekly exercise sessions with therapist in all settings
Time Frame: At discharge and end of rehabilitation in municipality
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The number of weekly exercise sessions with therapist at hospital, and in the municipality
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At discharge and end of rehabilitation in municipality
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Number of rehab weeks
Time Frame: At end of rehabilitation in municipality
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In the municipality
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At end of rehabilitation in municipality
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Type of training in Municipality
Time Frame: At end of rehabilitation in the Municipality
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Type of rehabilitation with a physiotherapist in Frederiksberg Municipality, at home or individual or team training in the centre, or a mixture of both
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At end of rehabilitation in the Municipality
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Training after discharge from 24-hour setting
Time Frame: At discharge from 24-hour setting
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If the patient has been on a 24-hour setting, is training then continued after discharge
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At discharge from 24-hour setting
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Home care, nurse/other health assistance, times pr week
Time Frame: At pre-fracture, at start and end of rehabilitation in municipality and 3-4 months and 1-year post-fracture
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Assistance with personal care, preparing dinner, grocery shopping, cleaning etc
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At pre-fracture, at start and end of rehabilitation in municipality and 3-4 months and 1-year post-fracture
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Data 30 days post-discharge
Time Frame: 30 day post-discharge
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The patient record will be reviewed and it will be recorded if the patient has been readmitted or has died.
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30 day post-discharge
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Data 3 months post-discharge
Time Frame: 3 month post-discharge
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The patient record will be reviewed and it will be recorded if the patient has been readmitted or has died.
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3 month post-discharge
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Data 1 year post-discharge
Time Frame: 1 year post-discharge
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The patient record will be reviewed and it will be recorded if the patient has undergone reoperation or has died.
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1 year post-discharge
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Morten T Kristensen, Professor, Fysio- og Ergoterapien, Bispebjerg-Frederiksberg Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P-2023-143
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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