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Hip FracturesHIP-ME-UPNCT05756517

Basic Mobility and Physical Activity During Hospitalization for a Hip Fracture: Functions Needed and Strategies Used

An observational study of Hip Fractures, run by Hvidovre University Hospital 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

Present study aim to gain an understanding of functions needed and strategies used for patients following hip fracture surgery to be independent in basic mobility activities during acute hospitalization, and establish knowledge of how much (or little) patients get out of bed. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Hip Fractures
How many people
101 participants
Where
1 siteDenmark
Study dates
8 Mar 2023to 7 Aug 2023
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients will be recruited from Hvidovre Hospital and Bispebjerg Hospital. A subgroup of patients from Hvidovre Hospital will also be recruited to the basic mobility satelite study (being filmed on 3-5 post operative day). This subpoplulation has slight different eligibility criteria. Addition to the inclusion criteria below: their pre-fracture CAS =6, able to give written informed consent, not later than on 5th postoperative day and able to speak and understand Danish. Additional exclusion criteria: Post operative medical complications limiting the patient from participating in physio- or occupational therapy, history of stroke with motor disability, cognitive dysfunction determined by chart review, reported by nursing staff, or observed by trained research staff (disoriented, dementia, active delirium), patient unwilling to participate in rehabilitation post-operative or do not want to cooperate for testing and to be filmed during transfer out/in of bed

Who may be able to join

  • Patients who have undergone surgery for hip fracture at Hvidovre Hospital admitted to department 210/212 or at Bispebjerg Hospital department M1.
  • Being able to participate in basic mobility activities with assistance pre-fracture (Cumulated Ambulation Score (by recall) ≥ 3)
  • Able to give written informed consent or having a relative/legal guardian to give written consent, not later than on 3rd postoperative day

Who cannot join

  • Postoperative weightbearing restrictions
  • Multiple fractures
  • Suspected pathological fracture due to cancer
  • Terminal illness
  • Post operative medical complications limiting the patient from getting out of bed
  • Patients with permanent residence in a nursing home
  • Patient unwilling to cooperate for testing

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Physio- and Occupational Therapy and Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre

    Copenhagen, Hvidovre, DK-2650

Other trials in Denmark

About this study

Official title: Basic Mobility and Levels of Physical Activity During Hospitalization for a Hip Fracture: Functions Needed and Strategies Used

Present study aim to gain an understanding of functions needed and strategies used for patients following hip fracture surgery to be independent in basic mobility activities during acute hospitalization, and establish knowledge of how much (or little) patients get out of bed.

Within the patients included in this cohort study (1), a subgroup will also be included in a satellite study (2), with a separate objective. Definitions are presented in the detailed description below (objectives 1-2).

Read the detailed description

The objectives are;

  1. To determine levels of physical activity among a broad representation of patients hospitalized following hip fracture surgery, and secondly to explore the association with 30-day readmission, and mortality.
  2. To understand and define which functions and strategies are needed for patients hospitalized following hip fracture surgery to be independent in the basic mobility activities: getting in/out of bed, sit-to-stand from a chair and walking.
Conditions
Hip Fractures
Medical subject headings
Hip Fractures

What is being measured

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

  1. 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 right thigh.

    Measured: Days of acute hospitalization (up to day 20)

Secondary outcomes (10)

  1. Basic mobility

    Will be measured using Cumulated Ambulation Score (CAS). The CAS score allows day-to-day measurements of basic mobility. 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 i maximum score indicating the patient to be independent in basic mobility).

    Measured: Daily on weekdays during hospitalization (up to day 20)

  2. 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: Registered at inclusion, but scored how they were 2 weeks before present hospitalization

  3. 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

  4. Nutrition risk screening

    Will be assessed by using Mini Nutritional Assessment Short Form (MNA-SF) which is a validated tool often used within research in this field.It has 6 items and ranges from 0 (malnourished) to 14 (normal nutritional status).

    Measured: At inclusion

  5. 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

  6. Pain at rest and walking

    Will be assessed using the 5-point Verbal Rating Scale (VRS, no pain, slight pain, moderate pain, severe pain, and unbearable pain) both at rest lying down and during walking.

    Measured: At inclusion, and at discharge (assessed up to day 20)

  7. Body strength

    Will be assessed using test of hand grip strength (HGS). 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 and 3-5 days post-operative.

  8. Pre-fracture physical activity

    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: Registered at inclusion, but recall the last few weeks before present hospitalization

  9. Filming patients performing basic mobility activities

    A subgroup of patients will be filmed when; (getting in and out of bed, sit-to-stand from a chair, and walking.

    Measured: On the 3-5 post-operative day

  10. Data 30 days post discharge

    Patient journal will be reviewed and there will be registered if the patient has been readmitted or has died.

    Measured: 30 days 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 posted6 Mar 2023
  2. Study start8 Mar 2023
  3. Primary completion26 Jun 2023
  4. Study completion7 Aug 2023

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
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05756517
Sponsor's protocol ID
HIP-ME-UP Study 1
Acronym
HIP-ME-UP
Status last verified
Aug 2023
First submitted
23 Feb 2023
Last updated
25 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hansen MS, Wassar Kirk J, Kristensen MT, Kampp Zilmer C, Marie Skibdal K, Bandholm T, Pedersen MM; HIP-ME-UP Collaborative Group. Strategies used by patients when getting in and out of bed early after hip fracture surgery - The HIP-ME-UP cohort. Hosp Pract (1995). 2025 Feb;53(1):2491305. doi: 10.1080/21548331.2025.2491305. Epub 2025 Apr 30.

    PubMed 40257221

  • Hansen MS, Kristensen MT, Zilmer CK, Berger AL, Kirk JW, Marie Skibdal K, Kallemose T, Bandholm T, Pedersen MM; HIP-ME-UP Collaborative Group. Very low levels of physical activity among patients hospitalized following hip fracture surgery: a prospective cohort study. Disabil Rehabil. 2025 Jan 21:1-10. doi: 10.1080/09638288.2025.2451769. Online ahead of print.

    PubMed 39835691

Questions about this trial

What is this clinical trial studying?

An observational study of Hip Fractures, run by Hvidovre University Hospital 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 3 inclusion and 7 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 25 Aug 2023. 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?

Physical activity/upright time (time standing and walking) (time frame: Days of acute hospitalization (up to day 20)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05756517, which also lists 2 linked publications.

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 25 Aug 2023.

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