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NCT Number: NCT07561164

Feasibility of a Co-designed Mobility Intervention After Hip Fracture Surgery

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location status: Recruiting

About this study

This study evaluates the feasibility, fidelity, and acceptability of a co-designed intervention developed within the HIP-ME-UP research program to promote early and frequent mobility among older adults hospitalized after hip fracture surgery.

Despite clinical recommendations for early mobilization, patients with hip fracture are often inactive during hospitalization, which may negatively impact recovery. The intervention was developed in collaboration with healthcare professionals, management, patients, and caregivers to address this gap.

The HIP-ME-UP intervention consists of four components:

  • A dedicated porter supporting physiotherapy and occupational therapy mobility activities
  • A standardized training concept to promote independence in getting in and out of bed
  • Group-based exercise supervised by physiotherapists
  • Personal activities of daily living (P-ADL) performed in the bathroom when feasible

The study uses a single-site, single-group feasibility design and will be conducted over an approximately 8-week period in orthopedic wards at Copenhagen University Hospital Hvidovre.

The primary aim is to assess whether the intervention can be delivered as intended in routine clinical practice. Feasibility outcomes include recruitment, retention, and data completeness. Fidelity will be assessed in terms of adherence to intervention content, dose, frequency, and quality of delivery. Acceptability will be explored through interviews and questionnaire responses among patients and healthcare professionals.

Clinical and functional outcomes, including mobility, physical activity, pain, and health-related quality of life, will be collected descriptively to support interpretation of feasibility findings and potential mechanisms of impact.

Feasibility will be evaluated using predefined progression criteria focusing on recruitment, retention, fidelity, and acceptability. These criteria will be interpreted using a traffic-light approach categorizing results as "stop", "amend", or "go". Progression decisions will be based on an integrated assessment of quantitative feasibility outcomes together with qualitative process data describing barriers, facilitators, and adaptations during implementation.

The findings will be reviewed by the HIP-ME-UP research group and steering committee to determine whether the intervention and trial procedures are sufficiently feasible to proceed to a future large-scale randomized effectiveness trial. The study is not designed to evaluate clinical effectiveness.

The study applies a feasibility-oriented outcome framework without hierarchical prioritization of outcomes. Feasibility, fidelity, acceptability, process data, and descriptive clinical outcomes are assessed in parallel, each contributing equally to a comprehensive evaluation of whether and how the HIP-ME-UP intervention can be delivered in routine clinical practice.

The study was assessed by the Regional Commitee on Health Research Ethics of the Capital Region of Denmark with journal no. H-26006578.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.
  • Inclusion the latest on postoperative day three.

Exclusion criteria

  • Non-ambulatory before the fracture, e.g. permanently bedbound or wheelchair-dependent.
  • Terminal illness with limited expected survival.
  • Post-operative weight-bearing restrictions precluding mobility activities.
  • 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.

Treatment and study plan

HIP-ME-UP mobility intervention

Behavioral

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.

Primary outcomes

  1. Recruitment rate

    Time frame: Continuous during recruitment period (up to 8 weeks)

    Proportion of patients providing informed consent among those assessed for eligibility

  2. Retention rate

    Time frame: At discharge and 4 months post-discharge

    Proportion of included participants completing planned assessments

  3. Data completeness

    Time frame: Through study completion, up to 4 months post-discharge

    Proportion of completed data among expected assessments

  4. Fidelity of intervention delivery

    Time frame: Continuously targeted observations during the 8-week intervention period

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

  5. Patient acceptability of the intervention

    Time frame: At discharge

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

  6. Healthcare professional acceptability of the intervention

    Time frame: The last four weeks of the intervention period or shortly thereafter

    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

Other outcomes

  1. Basic mobility independence

    Time frame: Daily from inclusion until discharge

    Assessed using the Cumulated Ambulation Score, range 0-6, higher scores indicate better mobility independence

  2. In-hospital mobility

    Time frame: Postoperative day 2, 4 and 6

    Assessed using Acute Care Mobility Assessment measuring walking activity during the previous 24 hours across three mobility levels (room, ward corridor, outside ward). Higher scores indicate greater in-hospital mobility

  3. Pre-fracture mobility

    Time frame: At inclusion and 4 months post-discharge

    Assessed using New Mobility Score, range 0-9, higher scores indicate better pre-fracture mobility

  4. Pain intensity

    Time frame: On inclusion and on postoperative day 2, 4, and 6

    Assessed using Verbal Rating Scale, range 0-4, higher scores indicate greater pain intensity. Pain will be assessed at rest and during activity

  5. Upright time

    Time frame: Daily from inclusion until discharge

    Time spent standing and walking measured using wearable SENS sensors

  6. Upright events

    Time frame: Daily from inclusion until discharge

    Number of transitions between postures measured using wearable SENS sensors

  7. Steps

    Time frame: Daily from inclusion until discharge

    Number of steps measured using wearable SENS sensors

  8. Health-related quality of life

    Time frame: At hospital discharge and 4 months post-discharge

    Assessed using the European Quality of Life - 5 Dimensions - 5 Levels questionnaire. EQ Visual Analogue Scale ranges from 0 to 100, where higher scores indicate better self-rated health. Five dimensions are rated from level 1 to level 5, where lower levels indicate better health

  9. Length of hospital stay

    Time frame: Number of days admitted during index hospitalization

    From admission to discharge during index hospitalization, assessed from patient medical records

  10. Discharge destination

    Time frame: At hospital discharge, up to 30 days after surgery

    Discharge destination, assessed from patient medical records

  11. Readmissions

    Time frame: From discharge until 4 months post-discharge

    Number of hospital readmissions, assessed from patient medical records

  12. Mortality

    Time frame: From discharge until 4 months post-discharge

    All-cause mortality, assessed from patient medical records

Study contacts

Contact information is provided by the study sponsor or research team.

Maria S Hansen, PhD

CONTACT

[email protected]

+45 38626191

Sofie T Lindholm, MHSc

CONTACT

[email protected]

+45 38622230

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Feasibility, Fidelity, and Acceptability of a Co-designed Intervention to Promote Mobility in Patients After Hip Fracture Surgery

Acronym: HIP-ME-UP

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 1, 2026
Registry last updated
May 29, 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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