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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Denmark

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.

Medical subject headings
Hip Fractures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. Number of falls

    Place and cause

    Measured: At start and end of rehabilitation in municipality, 3-4 months and 1 year post-fracture

  14. Residential status / discharge destination

    Residential status pre-fracture and discharge destination

    Measured: At discharge from hospital and 24-hour rehabilitation setting

  15. Length of stay in acute hospital

    Number of days

    Measured: From surgery till discharge

  16. 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

  17. Number of rehab weeks

    In the municipality

    Measured: At end of rehabilitation in municipality

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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.

  1. First posted12 Mar 2024
  2. Study start15 May 2023
  3. Primary completion15 May 2024
  4. Study completion15 May 2025

Resources

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)
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

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.

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