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Completed

NCT Number: NCT06304584

Cross-sectoral Rehabilitation of Older High-risk Patients With Hip Fracture

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Physio- and Occupational Therapy and Othopedic Surgery, University Hospital Bispebjerg and Frederiksberg

Copenhagen, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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).

  2. 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

    CST test measures how many times a person can stand up from a chair in 30 seconds, without using their arms.

  3. Timed Up & Go test (TUG)

    Time frame: At start and end of rehabilitation in municipality and 3-4 months post-fracture

    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

  4. 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

    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

  5. 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

    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.

  6. Health questionnaire

    Time frame: At pre-fracture (recall) and 3-4 months and 1-year post-fracture

    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.

  7. Physical activity (weekly)

    Time frame: At inclusion (recall of the last few weeks before present hospitalization) and 1-year post-fracture

    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

  8. Physical activity / upright time (time standing and walking)

    Time frame: From inclusion until 9 days post-discharge

    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.

  9. Frailty

    Time frame: At pre-fracture (recall) and 1-year post-fracture

    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).

  10. Fear of falling

    Time frame: At discharge and 3-4 months and 1-year post-fracture

    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.

  11. Comorbidity

    Time frame: At inclusion

    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.

  12. Cognitive status

    Time frame: At inclusion

    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.

  13. Number of falls

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

    Place and cause

  14. Residential status / discharge destination

    Time frame: At discharge from hospital and 24-hour rehabilitation setting

    Residential status pre-fracture and discharge destination

  15. Length of stay in acute hospital

    Time frame: From surgery till discharge

    Number of days

  16. Number of weekly exercise sessions with therapist in all settings

    Time frame: At discharge and end of rehabilitation in municipality

    The number of weekly exercise sessions with therapist at hospital, and in the municipality

  17. Number of rehab weeks

    Time frame: At end of rehabilitation in municipality

    In the municipality

  18. Type of training in Municipality

    Time frame: At end of rehabilitation in the 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

  19. Training after discharge from 24-hour setting

    Time frame: At discharge from 24-hour setting

    If the patient has been on a 24-hour setting, is training then continued after discharge

  20. 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

    Assistance with personal care, preparing dinner, grocery shopping, cleaning etc

  21. Data 30 days post-discharge

    Time frame: 30 day post-discharge

    The patient record will be reviewed and it will be recorded if the patient has been readmitted or has died.

  22. Data 3 months post-discharge

    Time frame: 3 month post-discharge

    The patient record will be reviewed and it will be recorded if the patient has been readmitted or has died.

  23. Data 1 year post-discharge

    Time frame: 1 year post-discharge

    The patient record will be reviewed and it will be recorded if the patient has undergone reoperation or has died.

Sponsors and collaborators

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Other

Collaborators

  • Frederiksberg Municipality

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 12, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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