Time on Feet After Hip Fracture Event (TOFFEE)

Time on Feet After Hip Fracture Event - the TOFFEE Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Fractures (ICD-10 72.01-72.2)
• Intervention / Treatment: Device: Inertial measurement unit

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Cecilia Rogmark, MD, PhD; Phone Number: +46705984992; Email: cecilia.rogmark@skane.se
• Study Contact Backup: Name: Therese Jönsson, PhD; Phone Number: +460703360721

Study Locations

• Sweden
  • Malmö, Sweden, 20502
    • Dept. of Orthopaedics, Skane University Hospital
    • Contact: Malin Lindahl, PT; Phone Number: +4640331000; Email: malin.lindahl@skane.se
    • Contact: Therese Jönsson, PT, PhD; Phone Number: +4646171000; Email: therese.jonsson@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People with acute hip fractures regardless of age or cognitive status. The fracture should need surgical treatment.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minutes in upright position per day	Sitting, standing or walking as measured by the IMU	During hospital stay, an average of one week

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Lund University
• Investigators: Principal Investigator: Cecilia Rogmark, PhD, Professor, Lund University; Study Chair: Eva Ekvall Hansson, PhD, Professor, Department of Health Sciences, Lund University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): November 22, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Estimated): November 21, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: rehabilitation; hip fracture; mobilization
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 2023-07759-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Swedish legislation is rigid on this point and request needs to be handled individually

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No