Clinical trial NCT06700031: Time on Feet After Hip Fracture Event
Official title: Time on Feet After Hip Fracture Event - the TOFFEE Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hip Fractures (ICD-10 72.01-72.2)
Keywords: hip fracture
mobilization
rehabilitation
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2024-11-21
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with acute hip fractures regardless of age or cognitive status. The fracture should need surgical treatment.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Minutes in upright position per day
timeFrame: During hospital stay, an average of one week
Secondary outcomes:
measure: Complications within 30 days
timeFrame: 30 days from surgery
measure: Association with type of fracture
timeFrame: During hospital stay, an average of one week
measure: Association with type of surgical method
timeFrame: During hospital stay, an average of one week
measure: Association with duration of surgery
timeFrame: During hospital stay, an average of one week
measure: Association with age
timeFrame: During hospital stay, an average of one week
measure: Association with sex
timeFrame: During hospital stay, an average of one week
measure: Association with comorbidities (ASA grade)
timeFrame: During hospital stay, an average of one week
measure: Association with frailty (CFS)
timeFrame: During hospital stay, an average of one week
measure: Association with presence of dementia
timeFrame: During hospital stay, an average of one week
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Dept. of Orthopaedics, Skane University Hospital
Study officials:
affiliation: Lund University
name: Cecilia Rogmark, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Health Sciences, Lund University
name: Eva Ekvall Hansson, PhD, Professor
role: STUDY_CHAIR
References:
citation: Moller U O, Fange A M, J K, D S, F F, Hansson E E. Modern technology against falls - A description of the MoTFall project. Health Informatics J. 2021 Apr-Jun;27(2):14604582211011514. doi: 10.1177/14604582211011514.
citation: Howell DF, Malmgren Fange A, Rogmark C, Ekvall Hansson E. Rehabilitation Outcomes Following Hip Fracture of Home-Based Exercise Interventions Using a Wearable Device-A Randomized Controlled Pilot and Feasibility Study. Int J Environ Res Public Health. 2023 Feb 10;20(4):3107. doi: 10.3390/ijerph20043107.