Hip Fracture SurgeryHIP-ME-UPNCT07561164
Feasibility of a Co-designed Mobility Intervention After Hip Fracture Surgery
A study testing HIP-ME-UP mobility intervention in people with Hip Fracture Surgery and Mobility Limitation, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fracture Surgery, Mobility Limitation, Postoperative Rehabilitation
- What is being tested?
- HIP-ME-UP mobility intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 11 May 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Fidelity, and Acceptability of a Co-designed Intervention to Promote Mobility in Patients 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.
Read more
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.
Read the detailed description
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.
- Being tested
- HIP-ME-UP mobility intervention
- Keywords
- Early mobility, Physical activity, Feasibility study, Frequent mobility, hospitalization, Fidelity
- Medical subject headings
- Mobility Limitation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIP-ME-UP mobility interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: HIP-ME-UP mobility intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Proportion of patients providing informed consent among those assessed for eligibility
Measured: Continuous during recruitment period (up to 8 weeks)
Retention rate
Proportion of included participants completing planned assessments
Measured: At discharge and 4 months post-discharge
Data completeness
Proportion of completed data among expected assessments
Measured: 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
Measured: 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
Measured: 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
Measured: The last four weeks of the intervention period or shortly thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start11 May 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hip Fracture SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group pre-post feasibility study evaluating feasibility, fidelity, and acceptability of a co-designed mobility intervention delivered during hospitalization after hip fracture surgery
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Swennergren Hansen, Copenhagen University Hospital, Hvidovre
- Investigators
- Maria S Hansen, PhD, Study director, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561164
- Sponsor's protocol ID
- HIP-ME-UP Feasibility Study
- Acronym
- HIP-ME-UP
- Status last verified
- Aug 2026
- First submitted
- 15 Apr 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Hansen MS, Staal ME, Bandholm T, Lindholm ST, Skibdal KM, Pedersen MM, Kirk JW. An ethnographic study of mobilization, basic mobility, physical activity, and exercise during acute hospitalization in patients following hip fracture surgery. Injury. 2026 Oct;57(10):113638. doi: 10.1016/j.injury.2026.113638. Epub 2026 Aug 26.
PubMed 42659875Hansen 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 40257221Hansen 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Fidelity, and Acceptability of a Co-designed Intervention to Promote Mobility in Patients After Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT07561164
- Acronym / sponsor ID
- HIP-ME-UP / HIP-ME-UP Feasibility Study
- Keywords
- Early mobility, Physical activity, Feasibility study, Frequent mobility, hospitalization, Fidelity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group pre-post feasibility study evaluating feasibility, fidelity, and acceptability of a co-designed mobility intervention delivered during hospitalization after hip fracture surgery
| Arm | Type | Receives |
|---|---|---|
| HIP-ME-UP mobility intervention | Experimental | Behavioral: HIP-ME-UP mobility interventionParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIP-ME-UP mobility interventionA 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. | Behavioural | HIP-ME-UP mobility intervention |
Primary outcome
Recruitment rate
Time frame: Continuous during recruitment period (up to 8 weeks)
Proportion of patients providing informed consent among those assessed for eligibility
Retention rate
Time frame: At discharge and 4 months post-discharge
Proportion of included participants completing planned assessments
Data completeness
Time frame: Through study completion, up to 4 months post-discharge
Proportion of completed data among expected assessments
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
Patient acceptability of the intervention
Time frame: At discharge
Assessed using semi-structured interviews assessing perceived relevance, appropriateness, and burden of the intervention
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 42659875Hansen MS, Staal ME, Bandholm T, Lindholm ST, Skibdal KM, Pedersen MM, Kirk JW. An ethnographic study of mobilization, basic mobility, physical activity, and exercise during acute hospitalization in patients following hip fracture surgery. Injury. 2026 Oct;57(10):113638. doi: 10.1016/j.injury.2026.113638. Epub 2026 Aug 26.
- Background: PubMed 40257221Hansen 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.
- Background: PubMed 39835691Hansen 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria S Hansen, PhD study director
Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIP-ME-UP mobility intervention in people with Hip Fracture Surgery and Mobility Limitation, 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Recruitment rate (time frame: Continuous during recruitment period (up to 8 weeks)). The study lists 6 primary outcomes in all. 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 NCT07561164, which also lists 3 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 18 Aug 2026.