Hvidovre Hospital
Hvidovre, 2650, Denmark
Location status: Recruiting
NCT Number: NCT07561164
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.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Not applicable
Hvidovre, 2650, Denmark
Location status: Recruiting
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Continuous during recruitment period (up to 8 weeks)
Proportion of patients providing informed consent among those assessed for eligibility
Time frame: At discharge and 4 months post-discharge
Proportion of included participants completing planned assessments
Time frame: Through study completion, up to 4 months post-discharge
Proportion of completed data among expected assessments
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
Time frame: At discharge
Assessed using semi-structured interviews assessing perceived relevance, appropriateness, and burden 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
Time frame: Daily from inclusion until discharge
Assessed using the Cumulated Ambulation Score, range 0-6, higher scores indicate better mobility independence
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
Time frame: At inclusion and 4 months post-discharge
Assessed using New Mobility Score, range 0-9, higher scores indicate better pre-fracture mobility
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
Time frame: Daily from inclusion until discharge
Time spent standing and walking measured using wearable SENS sensors
Time frame: Daily from inclusion until discharge
Number of transitions between postures measured using wearable SENS sensors
Time frame: Daily from inclusion until discharge
Number of steps measured using wearable SENS sensors
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
Time frame: Number of days admitted during index hospitalization
From admission to discharge during index hospitalization, assessed from patient medical records
Time frame: At hospital discharge, up to 30 days after surgery
Discharge destination, assessed from patient medical records
Time frame: From discharge until 4 months post-discharge
Number of hospital readmissions, assessed from patient medical records
Time frame: From discharge until 4 months post-discharge
All-cause mortality, assessed from patient medical records
Contact information is provided by the study sponsor or research team.
Maria S Hansen, PhD
CONTACT
Sofie T Lindholm, MHSc
CONTACT
Hvidovre University Hospital
Other
Feasibility, Fidelity, and Acceptability of a Co-designed Intervention to Promote Mobility in Patients After Hip Fracture Surgery
Acronym: HIP-ME-UP
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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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