Hip FracturesNCT06304584
Cross-sectoral Rehabilitation of Older High-risk Patients With Hip Fracture
An observational study of Hip Fractures and Rehabilitation, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Rehabilitation, Recovery of Function
- How many people
- 53 participants
- Where
- 1 siteDenmark
- Study dates
- 15 May 2023to 15 May 2025
- Phase
- Observational
- 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
Study population: Patients will be recruited from Bispebjerg Hospital, department M1
Who may be able to join
- 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
Who cannot join
- Living permanent in nursing home or is on the way to a permanent nursing home from a 24-hour setting.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Physio- and Occupational Therapy and Othopedic Surgery, University Hospital Bispebjerg and Frederiksberg
Copenhagen, 2400
About this study
Official title: 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:
Read more
- 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.
Read the detailed description
In addition to primary and secondary outcome measures some of the patients will be asked to respond to a interviewer-based questionnaire, about their experiences of the rehabilitation offered during their hospital stay and at the temporary municipality-based 24-hour setting / or at home during the first couple of months. Furthermore, they will be interviewed about their expectations for rehabilitation in the municipality at time of discharge from the acute hospital.
- Conditions
- Hip Fractures, Rehabilitation, Recovery of Function
- Medical subject headings
- Hip Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of pre-fracture function
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
Measured: Recovery of pre-fracture function at 3-4 months post-fracture as primary outcome
Secondary outcomes (23)
Basic mobility
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).
Measured: Pre-fracture, at inclusion and discharge from hospital, at start and end of rehabilitation in municipality, 3-4 months and 1 year post-fracture
30 second chair stand test (CST)
CST test measures how many times a person can stand up from a chair in 30 seconds, without using their arms.
Measured: At inclusion and discharge from hospital, at start and end of rehabilitation in municipality and 3-4 months post-fracture
Timed Up & Go test (TUG)
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
Measured: At start and end of rehabilitation in municipality and 3-4 months post-fracture
Hip related pain
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
Measured: At inclusion and discharge from hospital, at start and end of rehabilitation in municipality, 3-4 months and 1 year post-fracture
Hand Grip Strength (HGS)
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.
Measured: At inclusion at the hospital, at start and end of rehabilitation in municipality and 3-4 months post-fracture
Health questionnaire
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.
Measured: At pre-fracture (recall) and 3-4 months and 1-year post-fracture
Physical activity (weekly)
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
Measured: At inclusion (recall of the last few weeks before present hospitalization) and 1-year post-fracture
Physical activity / upright time (time standing and walking)
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.
Measured: From inclusion until 9 days post-discharge
Frailty
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).
Measured: At pre-fracture (recall) and 1-year post-fracture
Fear of falling
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.
Measured: At discharge and 3-4 months and 1-year post-fracture
Comorbidity
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.
Measured: At inclusion
Cognitive status
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.
Measured: At inclusion
Number of falls
Place and cause
Measured: At start and end of rehabilitation in municipality, 3-4 months and 1 year post-fracture
Residential status / discharge destination
Residential status pre-fracture and discharge destination
Measured: At discharge from hospital and 24-hour rehabilitation setting
Length of stay in acute hospital
Number of days
Measured: From surgery till discharge
Number of weekly exercise sessions with therapist in all settings
The number of weekly exercise sessions with therapist at hospital, and in the municipality
Measured: At discharge and end of rehabilitation in municipality
Number of rehab weeks
In the municipality
Measured: At end of rehabilitation in municipality
Type of training in Municipality
Type of rehabilitation with a physiotherapist in Frederiksberg Municipality, at home or individual or team training in the centre, or a mixture of both
Measured: At end of rehabilitation in the Municipality
Training after discharge from 24-hour setting
If the patient has been on a 24-hour setting, is training then continued after discharge
Measured: At discharge from 24-hour setting
Home care, nurse/other health assistance, times pr week
Assistance with personal care, preparing dinner, grocery shopping, cleaning etc
Measured: At pre-fracture, at start and end of rehabilitation in municipality and 3-4 months and 1-year post-fracture
Data 30 days post-discharge
The patient record will be reviewed and it will be recorded if the patient has been readmitted or has died.
Measured: 30 day post-discharge
Data 3 months post-discharge
The patient record will be reviewed and it will be recorded if the patient has been readmitted or has died.
Measured: 3 month post-discharge
Data 1 year post-discharge
The patient record will be reviewed and it will be recorded if the patient has undergone reoperation or has died.
Measured: 1 year post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 May 2023
- Primary completion15 May 2024
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Collaborators
- Frederiksberg Municipality
- Responsible party
- Principal investigator, Morten Tange Kristensen, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Morten T Kristensen, Professor, Study chair, Fysio- og Ergoterapien, Bispebjerg-Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304584
- Sponsor's protocol ID
- P-2023-143
- Status last verified
- Apr 2026
- First submitted
- 8 Feb 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06304584
- Acronym / sponsor ID
- P-2023-143
- Conditions
- Hip Fractures, Rehabilitation, Recovery of Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Collaborators
- Frederiksberg Municipality
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 12 Mar 2024 (actual)
- 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.
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.
Detailed description
In addition to primary and secondary outcome measures some of the patients will be asked to respond to a interviewer-based questionnaire, about their experiences of the rehabilitation offered during their hospital stay and at the temporary municipality-based 24-hour setting / or at home during the first couple of months. Furthermore, they will be interviewed about their expectations for rehabilitation in the municipality at time of discharge from the acute hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients will be recruited from Bispebjerg Hospital, department M1
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Living permanent in nursing home or is on the way to a permanent nursing home from a 24-hour setting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recovery of pre-fracture function
Time frame: Recovery of pre-fracture function at 3-4 months post-fracture as primary outcome
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
23 secondary outcomes
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
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
Timed Up & Go test (TUG)
Time frame: At start and end of rehabilitation in municipality and 3-4 months post-fracture
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
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
Health questionnaire
Time frame: At pre-fracture (recall) and 3-4 months and 1-year post-fracture
Physical activity (weekly)
Time frame: At inclusion (recall of the last few weeks before present hospitalization) and 1-year post-fracture
Physical activity / upright time (time standing and walking)
Time frame: From inclusion until 9 days post-discharge
Frailty
Time frame: At pre-fracture (recall) and 1-year post-fracture
Fear of falling
Time frame: At discharge and 3-4 months and 1-year post-fracture
Comorbidity
Time frame: At inclusion
Cognitive status
Time frame: At inclusion
Number of falls
Time frame: At start and end of rehabilitation in municipality, 3-4 months and 1 year post-fracture
Residential status / discharge destination
Time frame: At discharge from hospital and 24-hour rehabilitation setting
Length of stay in acute hospital
Time frame: From surgery till discharge
Number of weekly exercise sessions with therapist in all settings
Time frame: At discharge and end of rehabilitation in municipality
Number of rehab weeks
Time frame: At end of rehabilitation in municipality
Type of training in Municipality
Time frame: At end of rehabilitation in the Municipality
Training after discharge from 24-hour setting
Time frame: At discharge from 24-hour setting
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
Data 30 days post-discharge
Time frame: 30 day post-discharge
Data 3 months post-discharge
Time frame: 3 month post-discharge
Data 1 year post-discharge
Time frame: 1 year post-discharge
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 4 May 2026.
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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.
Morten T Kristensen, Professor study chair
Fysio- og Ergoterapien, Bispebjerg-Frederiksberg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Rehabilitation, run by University Hospital Bispebjerg and Frederiksberg 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 2 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 4 May 2026. 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?
Recovery of pre-fracture function (time frame: Recovery of pre-fracture function at 3-4 months post-fracture as primary outcome). 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 4 May 2026.