NCT07561164

Brief Summary

This clinical study examines whether a co-designed mobility intervention can be delivered in routine hospital care after hip fracture surgery. Hip fracture is a common and serious condition among older adults and is associated with loss of independence, complications, and increased mortality. During hospitalization, many patients remain inactive, even though early and frequent mobility is considered important for recovery. The HIP-ME-UP intervention was developed in collaboration with healthcare professionals, patients, caregivers, and hospital management. It aims to support early mobilization, independence in basic mobility activities such as getting in and out of bed and increased physical activity during hospitalization. The study will investigate whether the intervention is feasible to deliver in routine clinical practice, whether it is delivered as intended, and whether it is acceptable to patients and healthcare professionals. Participants admitted after a hip fracture surgery will receive the intervention during hospitalization. Researchers will collect information on recruitment, retention, fidelity, acceptability, and mobility-related outcomes. Approximately 25 participants will be included. The results will help determine whether a larger effectiveness study should be conducted.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Apr 2026

Status
not yet recruiting

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

Study Progress2%
Apr 2026Jun 2027

First Submitted

Initial submission to the registry

April 15, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

April 27, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 15, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

Early mobilityPhysical activityFeasibility studyFrequent mobilityhospitalizationFidelity

Outcome Measures

Primary Outcomes (6)

  • Recruitment rate

    Proportion of patients providing informed consent among those assessed for eligibility

    Continuous during recruitment period (up to 8 weeks)

  • Retention rate

    Proportion of included participants completing planned assessments

    At discharge and 4 months post-discharge

  • Data completeness

    Proportion of completed data among expected assessments

    Through study completion, up to 4 months post-discharge

  • Fidelity of intervention delivery

    Assessed via structured observations and logs reported as proportions and descriptive measures of adherence, dose, frequency, and quality

    Continuously targeted observations during the 8-week intervention period

  • Patient acceptability of the intervention

    Assessed using semi-structured interviews assessing perceived relevance, appropriateness, and burden of the intervention

    At discharge

  • Healthcare professional acceptability of the intervention

    Assessed using semi-structured interviews and questionnaire responses based on the Theoretical Framework of Acceptability. All questionnaire items are scored on a 5-point Likert scale (1-5), higher scores depend on the item/domain, with higher scores indicating either greater acceptability for positively framed items or greater burden for negatively framed items

    The last four weeks of the intervention period or shortly thereafter

Other Outcomes (12)

  • Basic mobility independence

    Daily from inclusion until discharge

  • In-hospital mobility

    Postoperative day 2, 4 and 6

  • Pre-fracture mobility

    At inclusion and 4 months post-discharge

  • +9 more other outcomes

Study Arms (1)

HIP-ME-UP mobility intervention

EXPERIMENTAL

Participants receive the HIP-ME-UP multicomponent mobility intervention during hospitalization after hip fracture surgery. The intervention aims to support early and frequent mobility through structured mobility support, supervised exercise, and encouragement of mobility-related daily activities.

Behavioral: HIP-ME-UP mobility intervention

Interventions

A multicomponent intervention designed to support early and frequent mobility during hospitalization after hip fracture surgery. The intervention includes a dedicated porter supporting mobility activities, standardized training concept to promote independence in bed transfer, group-based exercise supervised by physiotherapists, and encouragement of personal activities of daily living in the bathroom. The intervention is delivered by physiotherapists, occupational therapists, and porters as part of routine clinical care during hospitalization.

HIP-ME-UP mobility intervention

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 60 years.
  • Admitted to one of the two acute orthopedic wards at Copenhagen University Hospital Hvidovre (CUHH) following hip fracture surgery.
  • Pre-fracture Cumulated Ambulation Score (CAS) (by recall) ≥ 3 points, indicating independence or assisted independence in basic mobility activities such as bed transfer, chair transfer, and indoor walking.
  • Participants may be included if they are able to provide informed consent independently or if informed consent is obtained from a legally authorized proxy (e.g., caregiver or close relative) in cases of cognitive impairment. This applies to both Danish- and non-Danish speaking patients. Non-Danish speakers may be included with support from translated study materials and assistance from relatives or interpreters, where appropriate.

You may not qualify if:

  • Non-ambulatory before the fracture, e.g. permanently bedbound or wheelchair-dependent.
  • Terminal illness with limited expected survival.
  • Weight-bearing restrictions.
  • Multiple fractures or suspected pathological fractures (e.g. related to malignancy).
  • Clinically unstable or presenting conditions in which early mobilization is contraindicated.
  • Patients who previously participated in HIP-ME-UP Study 4, ensuring that recipients in Study 6 have not been prior HIP-ME-UP study participants or patient partners.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Hansen MS, Høite MES, Bandholm T, Lindholm ST, Skibdal KM, Pedersen MM. An ethnographic study of mobilization, basic mobility, physical activity, and exercise during acute hospitalization in patients following hip fracture surgery. medRxiv 2025.12.18.25342580; https://doi.org/10.64898/2025.12.18.25342580

    BACKGROUND
  • 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.

    PMID: 40257221BACKGROUND
  • 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.

    PMID: 39835691BACKGROUND

MeSH Terms

Conditions

Mobility LimitationMotor Activity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Maria S Hansen, PhD

    Copenhagen University Hospital, Hvidovre

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-group pre-post feasibility study evaluating feasibility, fidelity, and acceptability of a co-designed mobility intervention delivered during hospitalization after hip fracture surgery
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 15, 2026

First Posted

May 1, 2026

Study Start

April 27, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Due to Danish data protection legislation, individual participant data cannot be publicly shared. Access to pseudonymized data may be granted upon reasonable request and approval by the Danish Data Protection Agency.