NCT05756517

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

March 8, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

February 23, 2023

Last Update Submit

August 24, 2023

Conditions

Outcome Measures

Primary Outcomes (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.

    Days of acute hospitalization (up to day 20)

Secondary Outcomes (10)

  • Basic mobility

    Daily on weekdays during hospitalization (up to day 20)

  • Frailty

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

  • Cognitive status

    At inclusion

  • Nutrition risk screening

    At inclusion

  • Comorbidity

    At inclusion

  • +5 more secondary outcomes

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen, Hvidovre, DK-2650, Denmark

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Maria Swennergren Hansen, PT, PhD

    Department of Orthopedic Surgery and Department of Physio- and Occupational Therapy, Hvidovre Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post doc

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 6, 2023

Study Start

March 8, 2023

Primary Completion

June 26, 2023

Study Completion

August 7, 2023

Last Updated

August 25, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations