Skip to content

Time on Feet After Hip Fracture Event

Time on Feet After Hip Fracture Event - the TOFFEE Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06700031
Acronym
TOFFEE
Enrollment
40
Registered
2024-11-21
Start date
2024-11-22
Completion date
2026-03-31
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fractures (ICD-10 72.01-72.2)

Keywords

hip fracture, mobilization, rehabilitation

Brief summary

With simple technology investigators can map how long it takes for a patient with a hip fracture to be helped and encouraged to stand and walk in the days following the injury. A small sensor on the thigh can measure advanced data regarding movement patterns. The limited research results available show that patients spend too much time lying down or sitting, which can lead to poorer recovery, complications, and an increased risk of death. The project maps the current situation in orthopedic emergency care as well as in orthopedic geriatric care, which is provided in a modern building with single rooms and private bathrooms. In addition to better understanding the significance of different care models, the project aims to present baseline data that future intervention studies can use as control material. The project will also connect the activity level of the patients during the hospital stay with ongoing rehabilitation studies in community follow-up care.

Detailed description

Purpose and Specific Objectives Can better diagnosis and prevention of inactivity after hip fractures improve outcomes for individuals and society? The goal is to measure how much individuals with hip fractures move during their hospital stay, to investigate the link between activity levels and complications such as thromboembolism, infections, and mortality, and to use inertial measurement units (IMU) to provide feedback to patients and healthcare providers. Outcomes after frailty-related fractures remain poor, despite improved orthopedic surgical treatment. Every year, at least 50,000 people over the age of 65 in Sweden sustain a major fracture. Despite enhanced treatment and care, a fracture in older individuals often leads to permanent reductions in function and quality of life. Hip fractures are also associated with an increased risk of death. In addition to personal consequences, the many fractures have significant effects on healthcare and social elder care. Relatives are also affected. Falls are estimated to cost society over 14 billion kronor annually. To improve recovery and avoid complications after a fracture, coworkers must think broadly and innovatively in healthcare. Given the rapid changes in lifestyle and socioeconomics, it is questionable whether healthcare providers can apply research findings based on previous generations to today's older adults, for example concerning physical activity. A hip fracture is surgically treated so that the skeleton can withstand immediate weightbearing. However, patients spend too much time immobilized, according to the limited research available. This inactivity can lead to limited recovery, complications such as infections and thromboembolism, longer hospital stays, and an increased risk of death.

Interventions

DEVICEInertial measurement unit

A sensor, an inertial measurement unit (IMU), will be attached to the thigh when the individual is on the postoperative ward and will be worn throughout the hospital stay. The IMU measures 7.9 x 3.2 x 0.8 cm and records body positions, movements, and gait parameters.

Sponsors

Lund University
CollaboratorOTHER
Region Skane
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Having an acute hip fractures and being admitted to either two wards with orthopedic standard care or to one with orthogeriatric care at Skane University Hospital, Malmö

Exclusion criteria

* Lack of standing ability prior to the fracture, defined as requiring a sling lift for transfer * Skin disease that prevent the sensor from being attached (dry, flaky, or sore skin, or sensitivity to adhesive) * Additional fractures besides the hip fracture or other injuries that reduce mobility (e.g., head or thoracic injuries)

Design outcomes

Primary

MeasureTime frameDescription
Minutes in upright position per dayDuring hospital stay, an average of one weekSitting, standing or walking as measured by the IMU

Secondary

MeasureTime frameDescription
Association with type of fractureDuring hospital stay, an average of one weekAssociation between total time in upright position with type of fracture (intra- or extracapsular)
Association with type of surgical methodDuring hospital stay, an average of one weekAssociation between total time in upright position with type of surgical method (hemiarthroplasty, total hip arthroplasty, internal fixation)
Association with duration of surgeryDuring hospital stay, an average of one weekAssociation between total time in upright position with duration of surgery (min)
Association with ageDuring hospital stay, an average of one weekAssociation between total time in upright position with age (years)
Complications within 30 days30 days from surgeryMortality and Incidence of infection or venous thromboembolism within 30 days
Association with comorbidities (ASA grade)During hospital stay, an average of one weekAssociation between total time in upright position with comorbidities measured by ASA grade (American society of anesthesiologists classification system)
Association with frailty (CFS)During hospital stay, an average of one weekAssociation between total time in upright position with frailty (CFS - Clinical Frailty Score)
Association with presence of dementiaDuring hospital stay, an average of one weekAssociation between total time in upright position with presence of dementia (medical record information on ICD-code for dementia disease)
Association with sexDuring hospital stay, an average of one weekAssociation between total time in upright position with sex (male/female)

Countries

Sweden

Contacts

Primary ContactCecilia Rogmark, MD, PhD
cecilia.rogmark@skane.se+46705984992
Backup ContactTherese Jönsson, PhD
+460703360721

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026